Summary:
Pacira BioSciences, a leader in non-opioid pain management, is seeking a Regulatory Affairs professional to support clinical development projects and regulatory submissions. This role involves maintaining regulatory documentation (e.g., INDs, NDAs), supporting global submissions, managing timelines, and collaborating cross-functionally to ensure compliance and strategic execution of regulatory initiatives.
Key Responsibilities:
- Support preparation and submission of regulatory filings (INDs, NDAs, annual reports, global applications).
- Act as a Regulatory Affairs representative on project teams, providing strategic guidance.
- Author and review regulatory documents ensuring compliance and scientific accuracy.
- Contribute to regulatory strategy development and execution.
- Help prepare for health authority meetings and manage vendor contributions.
- Oversee and track project timelines and deliverables.
Qualifications:
- Bachelor’s or Master’s in life sciences with 3+ years in Regulatory Affairs; or
- Doctoral degree (Ph.D., M.D., Pharm.D.) with 1+ year of experience.
- Strong knowledge of clinical development and regulatory processes.
- Excellent communication, writing, and project management skills.
- Proficient in Microsoft Office; familiarity with project management tools a plus.
Why Join Pacira?
- Mission-driven work in non-opioid pain management
- Inclusive, collaborative culture with opportunities to make a real impact
Job sourced from Pacira BioSciences.