Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients. Our in-depth knowledge of non-opioid pain management, coupled with our passion for advancing patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results. Pacira BioSciences currently has an opening for a Associate Director, Regulatory CMC
This position provides regulatory expertise and leads regulatory projects for the Pacira Pharmaceuticals regulatory team.
Coordinate, write and review CMC sections for regulatory submission to US and international health agencies in the areas of new drug development, marketing applications, life-cycle management submissions, formal meeting briefing package.
- Ensure conformance to commitments made with various health agencies (e.g., IND/NDA/MAA commitments).
- Assist in developing regulatory strategies; identify and implement appropriate submission strategies for assigned projects. Provide input for product labeling, CMC changes and clinical projects.
- Coordinate the submissions and ensure regulatory submissions are of high quality and submitted in a timely manner; review submissions for accuracy, completeness, and compliance with applicable regulatory requirements and internal procedures.
- Participate in Regulatory interaction and presentations to Regulatory Health Authorities, customers and partners.
- Monitor and maintain awareness of regulatory environment assessing impact to business, interpret and disseminate information to affected departments.
- Other duties as assigned.
The qualified individual will possess the following:
Bachelor degree in life science from an accredited college or university
- Minimum 8 years progressively responsible experience in Regulatory Affairs in the U.S. pharmaceutical industry
- Demonstrated strong understanding of the U.S. and EU Regulatory requirements.
- Proven ability to interpret and apply regulations to specific projects (FDA and ICH or other regulatory agency guidance requirements).
- Excellent written and verbal English communication skills
- Demonstrated excellent organizational skills
- Proven negotiation skills.
- Proven ability to manage multiple projects, set priorities and meet deadlines.
- Excellent skill level in MS Office including Word, Excel and Outlook.
Equal Opportunity Employer/Veterans/Disabled