Job Description
Senior Regulatory Affairs Specialist
Job Purpose:
Manage regulatory activities to ensure compliance of pharmaceutical products with applicable regulations, guidelines, and company standards throughout the product lifecycle.
Key Responsibilities:
- Review and assess scientific and legal documents to ensure regulatory compliance.
- Prepare, organize, and maintain regulatory documentation and information.
- Ensure compliance with applicable regulatory requirements and industry guidelines.
- Maintain thorough knowledge of the company's product portfolio and related regulatory requirements.
- Monitor changes in regulatory legislation and guidelines and assess their impact on products.
- Analyze regulatory information and provide appropriate recommendations.
- Coordinate with cross-functional teams to ensure timely completion of regulatory activities.
- Support regulatory submissions, responses, renewals, variations, and other product lifecycle activities.
- Maintain accurate regulatory records and ensure timely follow-up on regulatory commitments.
Requirements:
- Bachelor's degree in pharmacy, Pharmaceutical Sciences, Science, or a related field.
- 4–7 years of relevant experience in Regulatory Affairs within the pharmaceutical industry.
- Strong knowledge of pharmaceutical regulations and regulatory guidelines.
- Professional English level is mandatory, with strong reading and writing skills to be assessed during screening.
- Strong computer skills, particularly MS Word and Excel.
- French language proficiency.
- Strong analytical and problem-solving skills.
- Excellent organizational and time management skills.
- Strong communication and interpersonal skills with the ability to work effectively across teams.
- High attention to detail and ability to manage multiple priorities.
