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Manager, Regulatory Affairs CMC
Job Description
- Participate on product and cross-functional teams to represent Regulatory Affairs and to advance company and project goals. Perform assessment of changes for Regulatory reportability and document with the change control and document management systems as needed. Advise SME teams on strategic activities to improve product supply, commercial, and regulatory outcomes.
- With supervision, 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, etc.
- Ensure conformance to commitments made with various health agencies (e.g., IND/NDA/MAA commitments).
- Assist in developing regulatory CMC strategies; identify and implement appropriate submission strategies for assigned projects. Provide input for product labeling, CMC changes and clinical projects.
- With supervision, 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.
- With supervision, 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.
- Bachelor's degree in life science or other related field required
- Minimum 4 years progressively responsible experience in Regulatory Affairs in the U.S. pharmaceutical industry required
- Demonstrated good knowledge 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 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
- 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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