My client is a CRO delivering discovery in preclinical and clinical drug development services. Some of their areas of expertise are translational medicine and clinical development. They have over a thousand employees based globally and they are seeking a Senior Regulatory Affairs Specialist to join their dynamic team! This is a full time permanent remote position.
- Prepare proposals, conduct meetings, and address regulatory submissions and strategy needs
- Interacts directly with the FDA and other regulatory bodies, as applicable
- Provide interpretive guidance on regulatory requirements on projects
- Provide regulatory expertise internally and externally
- Partner with clients to provide information as necessary to support their regulatory filings
- Author global regulatory filings
- Remains current with regulatory intelligence and ensures submissions are aligned with current standards/expectations
- Demonstrate expert knowledge of submission or technology-related global health authority guidelines/regulations
- Responsible for the overall regulatory affairs, intelligence, submissions and strategy scope including client relations and client development
- Develop options for regulatory strategy and intelligence
- Advanced Degree in a Scientific discipline
- 10+ years Biopharmaceutical, and/or Pharmaceutical, or Medical Device experience
- Former FDA or equivalent
If you believe that you are the right person for this role, please apply now. Alternatively, if you believe you know somebody in your network who would be suited to this position please forward the details, we offer a competitive referral fee. We also have a presence on LinkedIn and Twitter, or you can sign to our mailing list on our website to be kept up to date with our roles.
As specialist recruiters in life sciences, our mission is to create a positive impact in the world. We place visionary people in thriving cultures where they can create a brighter future. Our impact and what that means to society is why we go the extra mile. We even baked it into our name, Medella, which means to heal. Pairing brilliant scientists with brilliant companies we find wildly exciting, and it drives everything