Regulatory Affairs Manager
3 days ago
Job Summary:
The Regulatory Affairs Manager is responsible for ensuring the company's products meet all regulatory requirements in the markets where they are sold. This role involves managing regulatory submissions, ensuring compliance with national and international laws, and liaising with regulatory authorities to facilitate approvals and maintain compliance throughout the product lifecycle.
Key Responsibilities:
- Regulatory Submissions: Prepare and submit regulatory documents, dossiers, and applications (e.g., for product approval, renewals, or amendments) to relevant authorities (e.g., FDA, EMA, TGA, etc.).
- Compliance Management: Monitor and ensure ongoing compliance with regulatory requirements across different markets and product categories.
- Regulatory Strategy: Develop regulatory strategies and provide advice to internal teams (e.g., R&D, marketing, and manufacturing) to ensure regulatory compliance in product development, manufacturing, and commercialization.
- Liaison with Regulatory Authorities: Act as the point of contact between the company and regulatory bodies, managing communication, addressing inquiries, and handling inspections and audits.
- Regulatory Intelligence: Stay current on evolving regulatory requirements, industry trends, and new legislation to ensure the company's products remain compliant.
- Risk Assessment: Identify potential regulatory risks and advise on mitigation strategies to ensure the timely approval and market launch of products.
- Documentation and Reporting: Maintain thorough records of regulatory submissions, approvals, and communications with authorities.
- Cross-Functional Collaboration: Work closely with cross-functional teams (e.g., Quality, Marketing, R&D) to provide regulatory guidance and support throughout the product lifecycle.
- Training and Education: Provide training and updates to internal teams on regulatory requirements and compliance processes.
Qualifications:
- Education: Bachelor's degree in life sciences, pharmacy, chemistry, biology, food engineering or a related field (advanced degrees preferred).
- Experience: At least 8 years of experience in regulatory affairs within the food supplement, medical device.
- Knowledge: Strong knowledge of global regulatory requirements and guidelines (FDA, EMA, ICH, etc.).
- Skills: Excellent communication, project management, and problem-solving skills. Ability to interpret and apply regulatory guidelines effectively.
Mid-Senior level
Employment typeFull-time
Job functionLegal
IndustriesPharmaceutical Manufacturing
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