What are the responsibilities and job description for the Senior Regulatory Affairs Specialist position at Tucker Parker Smith Group (TPS Group)?
Regulatory Affairs Manager – Clinical & Nonclinical Submissions
Location: Fully Remote
Industry: Biotechnology / Pharmaceutical
Duration: 10 months (potential to extend or convert)
Pay: $60-70/hour
Our client is a leading biotechnology company known for developing breakthroughs in rare and specialty diseases. They combine cutting-edge science with a mission-driven culture, offering an environment where regulatory professionals can directly impact meaningful, life-changing therapies. This is an exciting chance to join a passionate team working at the forefront of global drug development.
About the Role
Our client, an innovative biotechnology company, is seeking a Regulatory Affairs Manager to support global nonclinical and clinical regulatory activities. This role helps drive regulatory strategy, supports Health Authority interactions, and contributes to key submissions across the product lifecycle.
What You’ll Do
- Support development of nonclinical/clinical regulatory strategy.
- Assist with planning and preparing for Health Authority (HA) meetings.
- Participate in cross-functional study and program teams.
- Contribute to IND/CTA updates, annual reports, protocols, and briefing documents.
- Coordinate and review regulatory submission content (INDs, CTAs, NDAs, BLAs).
- Partner with Regulatory Operations and Project Management on timelines and deliverables.
- Maintain and organize regulatory documentation and archived submissions.
- Support updates to core dossiers for international markets and lifecycle submissions.
What We’re Looking For
- Degree in a scientific discipline (e.g., life sciences, chemistry, molecular biology).
- PhD preferred; MS/BS with strong relevant experience also considered.
- 4 years of Regulatory Affairs experience, ideally within nonclinical and/or clinical development.
- Experience supporting global submissions and Health Authority interactions strongly preferred.
- Excellent communication, organizational, and cross-functional collaboration skills.
- Ability to manage multiple priorities and deliver high-quality work in a fast-paced environment.
Salary : $60 - $70