We are looking for a Senior Regulatory Affairs Analyst to manage regulatory activities for synthetic and biological drugs. This position is responsible for ensuring compliance with local health regulations, supporting product registration and renewal processes, and collaborating closely with global regulatory teams.
What you will do
- Prepare and submit registration dossiers for new products, post-registration changes, renewals, and other regulatory processes to ANVISA.
- Act as the primary point of contact to respond to ANVISA requirements and track the progress of dossier reviews.
- Review and approve promotional materials using the Veeva platform.
- Manage package insert and labeling updates based on changes to the global Core Data Sheet (CDS).
- Support inspections and renewals of Good Manufacturing Practice (BPF/GMP) certifications for international manufacturing plants.
- Monitor regulatory information, including public consultations, health resolutions, and competitor activities.
- Maintain regulatory databases and documentation up to date.
- Collaborate with cross-functional teams and participate in international regulatory meetings.
Who you are
You are an organized, detail-oriented, and proactive person, capable of working effectively under pressure. You demonstrate solid regulatory analysis capabilities, excellent communication skills, and strong collaboration with different areas of the organization.
Requirements
- Degree in Pharmacy, Biochemistry, or related fields.
- Experience in Regulatory Affairs.
- Solid knowledge of ANVISA regulations for synthetic and biological products.
- Advanced English (oral, written, and reading).
- Proficiency in Microsoft Office tools.
Preferred qualifications
- Experience with generic drug regulation.
- Previous participation in Good Manufacturing Practice (BPF/GMP) inspections.
Job Level: Professional
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.