Associate Director, Regulatory Affairs, CMC
Job Description
- 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.
- When needed, 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; advanced degree is preferred
- Minimum 8 years of progressively responsible experience in Regulatory Affairs or related CMC function in the U.S. pharmaceutical industry required
- Demonstrated strong understanding of the U.S., EU, and Canadian 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
- Ability to travel 15%
- 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
EEO Statement: Pacira is proud to be an Equal Opportunity Employer and does not discriminate against applicants because of race, color, religion, sex (including gender identity, sexual orientation, and pregnancy), national origin, age (40 or older), veteran status, disability or genetic information, or any other characteristic protected under applicable federal, state, or local law. At Pacira we are committed to intentionally cultivating a culture of inclusion where all feel welcomed and valued for their background, perspectives, and experiences. We hold one another accountable to promote trust and transparency in support of our communities and collective purpose.
Agency Disclaimer: Pacira Biosciences, Inc. (Hereafter, Pacira) does not accept unsolicited resumes from recruiters or employment agencies in response to the Pacira Careers page or a Pacira social media post. Pacira will not consider or agree to payment of any referral compensation or recruiter fee relating to unsolicited resumes. Pacira explicitly reserves the right to hire said candidate(s) without any financial obligation to the recruiter or agency. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Pacira.
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