Overview:
Meet is partnered with an innovative biopharmaceutical company dedicated to advancing treatments for rare diseases. We are looking for a driven regulatory professional to join our team as Senior Director, Regulatory Affairs. In this role, you will lead the creation and implementation of regulatory strategies, ensuring compliance with global regulations while supporting product launches, lifecycle management, and other critical initiatives. This is a hybrid position with 2 days in person per week.
Key Responsibilities:
- Lead the development of regulatory strategies and risk mitigation plans.
- Collaborate with cross-functional teams to support product approvals and submissions outside the US.
- Manage global regulatory submissions, ensuring consistency across regions.
- Provide regulatory guidance to product development teams and other functions (CMC, clinical, etc.).
- Draft and finalize responses to regulatory authority queries.
- Stay current on regulatory changes and communicate updates to internal teams.
Qualifications:
- Advanced degree (MSc, PhD, PharmD) in a life sciences or related field.
- At least 15 years of pharmaceutical regulatory experience, including 5 years of international experience.
- Expertise in regulatory affairs for rare diseases, with experience in regions like the EU, APAC, and LATAM preferred.
- Proven ability to manage complex projects and adapt to changing priorities.
- Strong skills in MS Office, document management, and submission processes.
- Excellent communication, negotiation, and interpersonal skills.
*Please note that this position does not offer visa sponsorship or support for visa transfers. Applicants must have current, unrestricted authorization to work in the United States.
