![Director, Regulatory Affairs - CMC Director, Regulatory Affairs - CMC](https://www.workplacediversity.com/sites/default/files/styles/job_squared_logo_medium/public/org_logos/212513_1694007694.jpg?itok=Ppcg2R9x)
Director, Regulatory Affairs - CMC
Leadership / Executive Board
Full Time
About Pacira
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. Each of our 3 marketed products, both in pharmaceutical and medical device, represent cutting edge technologies for pain management. We have 700+ employees and have averaged double digit growth year over year for the past 5 years, with $500M in revenue. We are small enough for you to make your mark, and big enough for you to learn and grow! We have facilities in New Jersey, California and Florida. Our San Diego, CA campus is a world class manufacturing and R&D facility. We are rapidly growing and have opportunities across all of our sites and functional areas.
Why work with us?
Rarely do you have an opportunity to do work that really matters. What drives us is our mission. What makes us successful are our people. At Pacira, you are part of an inclusive culture that fosters collaboration, growth, and innovative thinking – a place where you can make an impact and help change the standard of care in non-opioid pain management. Be part of our movement, let’s pursue excellence together. Summary:This position is responsible for assigned regulatory projects to ensure regulatory compliance for approved marketing applications (NDA/MAA/NDS etc.) and leading to successful preparation of clinical trial applications (IND/CTA etc.). It also provides regulatory expertise to the Pacira Pharmaceuticals regulatory team.Essential Duties & Responsibilities:The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned.
- Prepare regulatory filings for submission to US and international health agencies in the areas of new drug development, marketing applications and approved product support. This would include IND applications, annual reports, Investigator brochures, and meeting requests
- Ensure conformance to commitments made with various health agencies (e.g., IND/NDA/MAA/NDS commitments).
- Propose and/or assist in developing regulatory strategies; identify and implement appropriate submission strategies for assigned projects.
- Work with submission manager to 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.
- Can act as regulatory affairs CMC liaison with partner companies and contract manufacturers
- Other duties as assigned.
- Bachelor’s degree in life science or related discipline required
- Minimum 10 years of progressively responsible experience in Regulatory Affairs in the U.S. pharmaceutical industry required
- Demonstrated strong understanding of the U.S. 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 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
- Medical, Prescription, Dental, Vision Coverage
- Flexible Spending Account & Health Savings Account with Company match
- Employee Assistance Program
- Mental Health Resources
- Disability Coverage
- Life insurance
- Critical Illness and Accident Insurance
- Legal and Identity Theft Protection
- Pet Insurance
- Fertility and Maternity Assistance
- 401(k) with company match
- Flexible Time Off (FTO) and 11 paid holidays
- Paid Parental Leave
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