Regional Senior Regulatory Affairs Manager

3 days ago

บางรก กรงเทพมหานคร, Thailand PRTR Full time

**Responsibilities**:

- Using regulatory experiences and insights as input to support Head of RA to formulate and execute regulatory strategies to secure registration of products (both recipe and label) with government authorities.
- Reviewing, validating, and giving suggestions in the area of specialized nutrition, nutrition composition & specifications, labeling and packaging design are compiled under local regulation, international regulation, and the company’s guidelines and policies framework
- Achieving the registration process to get FDA approval as plan and ensuring all concerned documents are completed and ready to be submitted for FDA’s consideration i.e. Application form, GMP certificate, COA, COF, Product specification sheet, Certificate of the manufacturer, import license, Label, Clinical study, etc.
- Closely monitoring and following up on product/label registrations to ensure it is as per the project timeline /plan.
- Communicating immediately to management and relevant cross-functional team member in the project team if the registration process is expected to delay, require more information, or may impact the product launch plan.
- Solving the problems that are from government agencies by giving and receiving recommendation to and from the relevant cross-functional team so that registration can be completed as per plan.
- Anticipating and/or identifying the emerging risks & opportunities related to registration of product/label, then assessing the impact, recommending risk mitigation and providing regulatory risk assessment when necessary.
- Contributing to innovation projects by bringing regulatory expertise & solutions, information, and suggestion to the project team.
- Giving regulatory guidance and updates to colleagues (SEA GS, Supply Point and CBU).
- Supporting the development and implementation of regulatory guidelines & tools to facilitate sustainable registration of products.
- Coordinating with Scientific Affairs/R&I to consolidate scientific dossier consisting of clinical trials, and research papers and submit to government agencies to get the approval of FSMP or novel food or the use of novel ingredient or new health claim in the product.
- Supporting the deployment of global GS initiatives such as Compliance.
- Conducting mandatory labeling requirement/government product/label registration training to colleagues from SEA GS, Supply Point, and CBU.
- Nurturing productive relationships with influential officers from FDA, provincial FDA, and DLD.
- Anticipating and managing the evolving regulatory environment through proactive monitoring of the development of international and local regulatory standards.
- Attending technical meetings organized by Industry/ government bodies to support the Head of RA to influence and shape the regulatory environment.
- Continuously developing company image with relevant government key officers.
- Working towards being seen as a regulatory expert in the area of specialized nutrition.
- Coordinating and working with CBU and Supply point regarding the license to operate, food safety, product compliance, and food regulatory issues.
- Maintaining good filing of all labels vetted and approved by MOH.
- Maintaining a good filing of letters, meeting minutes, and directives from authorities, company, and industry.

**Qualifications**:

- Thai Only.
- BA or Master's Degree in Food Science/Nutrition or Dietetics and/or Pharmacy or relevant science field (preferable Master's Degree).
- Minimum 8 years experience in regulatory affairs in the nutrition business or food industry.
- Good knowledge and experience with Food laws and regulations in Thailand and Codex Standards/EU.
- Ethical and trustworthy, service-oriented, good negotiation, and presentation skills.
- Good attitude/interpersonal skills and collaborative mindset.
- Flexible and able to work under pressure.
- Coaching, facilitator, and training skill.
Problem solving & detail-oriented with strong analytical thinking skill.

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