5 Regulatory Affairs jobs in Qatar

Premium Solutions Consultancy is seeking a highly skilled and motivated Regulatory Affairs professional to join our team. As a Regulatory Affairs Specialist, you will be responsible for ensuring compliance with regulatory requirements and guidelines for our client projects. You will work closely with cross-functional teams to prepare and submit regulatory applications, maintain product registrations, and monitor regulatory changes. Responsibilities Prepare and submit regulatory applications, including product registrations and notifications Coordinate with internal and external stakeholders to collect necessary documentation and information Maintain up-to-date knowledge of relevant regulations and guidelines Monitor and communicate changes in regulatory requirements that may impact our clients Conduct regulatory assessments for new products and ensure compliance throughout the product lifecycle Participate in regulatory agency inspections and audits Collaborate with cross-functional teams to develop regulatory strategies and plans Review and provide input on labeling and promotional materials to ensure compliance Requirements Bachelor's degree in a scientific or healthcare-related field Minimum of 3 years of experience in regulatory affairs in the pharmaceutical, medical device, or biotechnology industry Strong knowledge of local and international regulatory requirements and guidelines Excellent communication and project management skills Experience in preparing and submitting regulatory applications Attention to detail and strong analytical skills Ability to work independently and in a team environment

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Job Description

OBJECTIVE/ PURPOSE OF THE JOB

The key objective of the Regulatory Affairs Specialist is to ensure that all products within the Beauty Division and the steps involved in registering, testing and marketing them, meet legislative requirements. Typical duties include; studying scientific and legal documents to ensure compliance with applicable laws and regulations within each respective country. They will be responsible on all compliance related matters within the Beauty Industry regulations by navigating the company through the governments continually changing policies and must ensure compliance and release of the product in the market on time. Overall, their strategic directive is to achieve a balance between regulatory concerns, technology, marketing objectives, compliance, time to market, and costs.

Key Responsibilities

• Navigating Regulatory Requirements: Staying abreast of evolving regulations and guidelines pertinent to the industry and ensuring products meet these standards.
• Documentation and Submission: Compiling, organizing, and submitting regulatory documentation required for product approvals, licenses, and permits.
• Communication Liaison: Serving as a liaison between the company and regulatory authorities, facilitating communication and addressing inquiries or concerns.
• Compliance Management: Monitoring and ensuring ongoing compliance with regulatory requirements throughout the product lifecycle, from brand onboarding to marketing and post-market surveillance.
• Risk Assessment: Conducting risk assessments to evaluate potential impacts of regulatory changes or non-compliance on product development and market approval.
  
  

Core Responsibilities

• Ensure that a Company's products comply with the regulations of the regions where they want to distribute them
• Ensure the Company maintains compliance with all regulatory requirements and standards to protect consumer safety and company reputation
• Keeping up to date with regulatory changes to ensure that a company's products comply with the regulations of the regions where they want to distribute them
• Advise the company on necessary adjustments and ensure all changes are carried out
• Ensure compliance with all relevant ISO standards in the region, including regulations for cosmetics and other beauty products
• Regularly reporting on compliance status and measures to both internal and external parties
• Explaining industry regulations, policies, and procedures to respective personnel
• Serve as the primary point of contact for regulatory agencies and address inquiries or issues
• Advising Division on regulatory and compliance matters
• Identifying and interpreting relevant regulatory guidelines for Division
• Evaluate applicable laws and regulations to determine impact on Company activities
• Studying scientific and legal documents to check they meet legal requirements
• Review product formulations to ensure a smooth approval process with authorities
• Providing technical reviews of reports for regulatory compliance
• Maintaining familiarity with Division product ranges
• Submitting information and responding to queries from medical bodies on Medical Cosmetics and Healthcare products with the Ministry of Health in the respective Countries
• Advise brand scientists and manufacturers on regulatory requirements
• Undertake and manage regulatory inspections
• Liaise with, and make presentations to, regulatory authorities
• Protect consumer safety and uphold the company's reputation by ensuring all products meet legal and safety standards in the region
• Validates stock for daily distribution
  
  

Document Management, Recording and Audits

• Preparation of all the necessary documents for new product registration applications and for product registration renewal
• Reviews the data accuracy prepared for compliance and highlights variances to the respective manager
• Continually follows up on product registration submissions under review
• Managing regulated documentation for certifying bodies or government agencies
• Maintaining critical data related to regulatory compliance in databases or information systems
• Maintain detailed records of product ingredients and formulations for regulatory reporting
• Maintains a database of all product approvals and under approval with active status and keep a full compilation of records A-Z.
• Maintaining data and files for future reference, particularly in the event of an audit by a regulatory agency
• Participate in regulatory audits and inspections and implement corrective actions as needed
  
  

License Renewals

• Develop and write clear arguments and explanations for new product licenses and license renewals
• Prepare submissions of license variations and renewals to strict deadlines
• Monitor and set timelines for license variations and renewal approvals.
  
  

Marketing Compliance

• Presenting registration documents to regulatory agencies and carrying out any subsequent negotiations necessary to obtain or maintain marketing authorization for the products concerned
• Provide accurate and timely action on product labeling to meet regulatory requirements.
• Write clear, accessible non-removable product labels in Arabic for over-labelling of products to comply with governmental standards
• Take part in the development of marketing concepts and approve packaging and advertising before a product's release.
• Outline requirements for product storage.
  
  

Others

• Provide training to staff on regulatory requirements and best practices.
• Develops regulatory affairs SOP's for the Division and ensures that it is adhered to
  
  

Skills

JOB REQUIREMENT

Education and Qualification

• A Bachelor's degree in Pharmacy, Science, Law, or a related field is preferred.
• Majors in biochemistry, biological sciences, chemistry, pharmacy, pharmacology, toxicology, medicine, or engineering are desirable, though not mandatory.
• A pharmacist license in Qatar is preferred but not required.
• Holding a pharmacist license in the UAE, KSA, Kuwait, Bahrain, or Oman is considered an advantage.
  
  

Work Experience

• A minimum of 2-3 years of experience in a Regulatory Affairs role is essential.
• Experience in the pharmaceutical industry is desirable but not mandatory.
• A strong understanding of regulatory procedures for beauty products is required.
• Experience with the registration of beauty products within the GCC is considered an advantage.
  
  

Skills And Abilities

• Fluency in both Arabic and English Languages
• Advanced knowledge in MS Office including Outlook, Word, Excel and PPT
• Proven ability to understand both legal and scientific matters
• Skilled at interpreting complex technical information and translating it into clear, actionable insights
• Quick to grasp new concepts and adept at assimilating and evaluating scientific data
• Professional ability to communicate in Business Language
• Proficient Communication Skills, Interpersonal Skills, Critical Thinking

Job Description

OBJECTIVE/ PURPOSE OF THE JOB

The key objective of the Regulatory Affairs Specialist is to ensure that all products within the Beauty Division and the steps involved in registering, testing and marketing them, meet legislative requirements. Typical duties include; studying scientific and legal documents to ensure compliance with applicable laws and regulations within each respective country. They will be responsible on all compliance related matters within the Beauty Industry regulations by navigating the company through the governments continually changing policies and must ensure compliance and release of the product in the market on time. Overall, their strategic directive is to achieve a balance between regulatory concerns, technology, marketing objectives, compliance, time to market, and costs.

Key Responsibilities

Navigating Regulatory Requirements: Staying abreast of evolving regulations and guidelines pertinent to the industry and ensuring products meet these standards. Documentation and Submission: Compiling, organizing, and submitting regulatory documentation required for product approvals, licenses, and permits. Communication Liaison: Serving as a liaison between the company and regulatory authorities, facilitating communication and addressing inquiries or concerns. Compliance Management: Monitoring and ensuring ongoing compliance with regulatory requirements throughout the product lifecycle, from brand onboarding to marketing and post-market surveillance. Risk Assessment: Conducting risk assessments to evaluate potential impacts of regulatory changes or non-compliance on product development and market approval.

Core Responsibilities

Ensure that a Company’s products comply with the regulations of the regions where they want to distribute them Ensure the Company maintains compliance with all regulatory requirements and standards to protect consumer safety and company reputation Keeping up to date with regulatory changes to ensure that a company’s products comply with the regulations of the regions where they want to distribute them Advise the company on necessary adjustments and ensure all changes are carried out Ensure compliance with all relevant ISO standards in the region, including regulations for cosmetics and other beauty products Regularly reporting on compliance status and measures to both internal and external parties Explaining industry regulations, policies, and procedures to respective personnel Serve as the primary point of contact for regulatory agencies and address inquiries or issues Advising Division on regulatory and compliance matters Identifying and interpreting relevant regulatory guidelines for Division Evaluate applicable laws and regulations to determine impact on Company activities Studying scientific and legal documents to check they meet legal requirements Review product formulations to ensure a smooth approval process with authorities Providing technical reviews of reports for regulatory compliance Maintaining familiarity with Division product ranges Submitting information and responding to queries from medical bodies on Medical Cosmetics and Healthcare products with the Ministry of Health in the respective Countries Advise brand scientists and manufacturers on regulatory requirements Undertake and manage regulatory inspections Liaise with, and make presentations to, regulatory authorities Protect consumer safety and uphold the company’s reputation by ensuring all products meet legal and safety standards in the region Validates stock for daily distribution

Document Management, Recording and Audits

Preparation of all the necessary documents for new product registration applications and for product registration renewal Reviews the data accuracy prepared for compliance and highlights variances to the respective manager Continually follows up on product registration submissions under review Managing regulated documentation for certifying bodies or government agencies Maintaining critical data related to regulatory compliance in databases or information systems Maintain detailed records of product ingredients and formulations for regulatory reporting Maintains a database of all product approvals and under approval with active status and keep a full compilation of records A-Z. Maintaining data and files for future reference, particularly in the event of an audit by a regulatory agency Participate in regulatory audits and inspections and implement corrective actions as needed

License Renewals

Develop and write clear arguments and explanations for new product licenses and license renewals Prepare submissions of license variations and renewals to strict deadlines Monitor and set timelines for license variations and renewal approvals.

Marketing Compliance

Presenting registration documents to regulatory agencies and carrying out any subsequent negotiations necessary to obtain or maintain marketing authorization for the products concerned Provide accurate and timely action on product labeling to meet regulatory requirements. Write clear, accessible non-removable product labels in Arabic for over-labelling of products to comply with governmental standards Take part in the development of marketing concepts and approve packaging and advertising before a product's release. Outline requirements for product storage.

Others

Provide training to staff on regulatory requirements and best practices. Develops regulatory affairs SOP’s for the Division and ensures that it is adhered to

Skills

JOB REQUIREMENT

Education and Qualification

A Bachelor's degree in Pharmacy, Science, Law, or a related field is preferred. Majors in biochemistry, biological sciences, chemistry, pharmacy, pharmacology, toxicology, medicine, or engineering are desirable, though not mandatory. A pharmacist license in Qatar is preferred but not required. Holding a pharmacist license in the UAE, KSA, Kuwait, Bahrain, or Oman is considered an advantage.

Work

Experience

A minimum of 2–3 years of experience in a Regulatory Affairs role is essential. Experience in the pharmaceutical industry is desirable but not mandatory. A strong understanding of regulatory procedures for beauty products is required. Experience with the registration of beauty products within the GCC is considered an advantage.

Skills And Abilities

Fluency in both Arabic and English Languages Advanced knowledge in MS Office including Outlook, Word, Excel and PPT Proven ability to understand both legal and scientific matters Skilled at interpreting complex technical information and translating it into clear, actionable insights Quick to grasp new concepts and adept at assimilating and evaluating scientific data Professional ability to communicate in Business Language Proficient Communication Skills, Interpersonal Skills, Critical Thinking

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OBJECTIVE/ PURPOSE OF THE JOB The key objective of the Regulatory Affairs Specialist is to ensure that all products within the Beauty Division and the steps involved in registering, testing and marketing them, meet legislative requirements. Typical duties include; studying scientific and legal documents to ensure compliance with applicable laws and regulations within each respective country. They will be responsible on all compliance related matters within the Beauty Industry regulations by navigating the company through the governments continually changing policies and must ensure

compliance and release of the product in the market on time. Overall, their strategic directive is to achieve a balance between regulatory concerns, technology, marketing objectives, compliance, time to market, and costs. KEY RESPONSIBILITIES Navigating Regulatory Requirements

: Staying abreast of evolving regulations and guidelines pertinent to the industry and ensuring products meet these standards. Documentation and Submission:

Compiling, organizing, and submitting regulatory documentation required for product approvals, licenses, and permits. Communication Liaison:

Serving as a liaison between the company and regulatory authorities, facilitating communication and addressing inquiries or concerns. Compliance Management:

Monitoring and ensuring ongoing compliance with regulatory requirements throughout the product lifecycle, from brand onboarding to marketing and post-market surveillance. Risk Assessment:

Conducting risk assessments to evaluate potential impacts of regulatory changes or non-compliance on product development and market approval. Core Responsibilities Ensure that a Company’s products comply with the regulations of the regions where they want to distribute them Ensure the Company maintains compliance with all regulatory requirements and standards to protect consumer safety and company reputation Keeping up to date with regulatory changes to ensure that a company’s products comply with the regulations of the regions where they want to distribute them Advise the company on necessary adjustments and ensure all changes are carried out Ensure compliance with all relevant ISO standards in the region, including regulations for cosmetics and other beauty products Regularly reporting on compliance status and measures to both internal and external parties Explaining industry regulations, policies, and procedures to respective personnel Serve as the primary point of contact for regulatory agencies and address inquiries or issues Advising Division on regulatory and compliance matters Identifying and interpreting relevant regulatory guidelines for Division Evaluate applicable laws and regulations to determine impact on Company activities Studying scientific and legal documents to check they meet legal requirements Review product formulations to ensure a smooth approval process with authorities Providing technical reviews of reports for regulatory compliance Maintaining familiarity with Division product ranges Submitting information and responding to queries from medical bodies on Medical Cosmetics and Healthcare products with the Ministry of Health in the respective Countries Advise brand scientists and manufacturers on regulatory requirements Undertake and manage regulatory inspections Liaise with, and make presentations to, regulatory authorities Protect consumer safety and uphold the company’s reputation by ensuring all products meet legal and safety standards in the region Validates stock for daily distribution Document Management, Recording and Audits Preparation of all the necessary documents for new product registration applications and for product registration renewal Reviews the data accuracy prepared for compliance and highlights variances to the respective manager Continually follows up on product registration submissions under review Managing regulated documentation for certifying bodies or government agencies Maintaining critical data related to regulatory compliance in databases or information systems Maintain detailed records of product ingredients and formulations for regulatory reporting Maintains a database of all product approvals and under approval with active status and keep a full compilation of records A-Z. Maintaining data and files for future reference, particularly in the event of an audit by a regulatory agency Participate in regulatory audits and inspections and implement corrective actions as needed License Renewals Develop and write clear arguments and explanations for new product licenses and license renewals Prepare submissions of license variations and renewals to strict deadlines Monitor and set timelines for license variations and renewal approvals. Marketing Compliance Presenting registration documents to regulatory agencies and carrying out any subsequent negotiations necessary to obtain or maintain marketing authorization for the products concerned Provide accurate and timely action on product labeling to meet regulatory requirements. Write clear, accessible non-removable product labels in Arabic for over-labelling of products to comply with governmental standards Take part in the development of marketing concepts and approve packaging and advertising before a product's release. Outline requirements for product storage. Others Provide training to staff on regulatory requirements and best practices. Develops regulatory affairs SOP’s for the Division and ensures that it is adhered to

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