Job Title: Associate Director, Regulatory Affairs – Biosimilar/BLA
Location: Piscataway, NJ, United States
Company: Amneal Pharmaceuticals
Job Category: Regulatory Affairs
Job Schedule: Full-time
Company Overview
Amneal Pharmaceuticals is a global pharmaceutical company focused on developing high-quality medicines, including biologics and biosimilars. The company emphasizes regulatory compliance, innovation, and cross-functional collaboration to advance patient care.
Job Overview
The Associate Director of Regulatory Affairs will serve as a regulatory expert for Biosimilar and Biologics License Application (BLA) submissions. The role includes strategizing, leading, and managing global regulatory submissions, providing regulatory guidance, and supporting post-approval activities.
Key Responsibilities
Regulatory Strategy & Submission
Develop and execute global regulatory strategies for Biologics, Biosimilars, and Small Molecules.
Lead CMC and clinical regulatory strategy formulation, aligning with regulatory trends and business goals.
Oversee planning, authoring, reviewing, and coordination of regulatory filings (e.g., BLA, MAA).
Ensure timely, high-quality submissions meeting global regulatory requirements.
Health Authority Interaction
Lead interactions with Health Authorities (FDA, EMA, Health Canada).
Prepare briefing books, plan rehearsals, and mitigate regulatory risks.
Represent Regulatory Affairs on cross-functional teams addressing regulatory issues.
Guidance & Compliance Oversight
Provide strategic regulatory advice to cross-functional teams.
Assess regulatory impact of changes in CMC procedures.
Develop and maintain internal regulatory guidance documents.
Development & Post-Approval Support
Collaborate on development, submission, and post-approval activities from a regulatory perspective.
Maintain partnerships with internal and external stakeholders to ensure smooth regulatory processes.
Stay updated on all regulatory activities for new and approved drug products.
Qualifications & Experience
Education:
Required: Master’s degree in Science (Chemistry, Pharmacy, Biochemistry, Molecular Biology, Biotechnology, Biology).
Experience:
Minimum 11 years in Regulatory Affairs, specifically with Biosimilar/BLA submissions.
Skills:
Advanced time management, organization, multitasking, and prioritization skills.
High accuracy and attention to detail while meeting deadlines.
Excellent written, verbal, and interpersonal communication skills.
Ability to work independently and collaboratively in a team structure.
Effective problem-solving and regulatory strategy skills.
Experience interfacing with professionals domestically and internationally.
Specialized Knowledge:
Prior experience with Biologics License Applications (BLAs).
Knowledge of ICH and FDA regulations.
Experience managing complex CMC regulatory issues and submission processes.
Broad knowledge of regulatory submission modules (Module 3, 4, 5).
Proficiency in MS Word, Excel, Outlook, eCTD software, and Adobe Acrobat.
Strong presentation and scientific/technical writing skills.
Leadership experience within a regulatory affairs function.
Salary & Benefits
Base salary range: $170,000 – $200,000 per year
Eligibility for short-term incentive opportunities within the first 12 months.
Comprehensive benefits including health insurance, 401(k) matching, and programs promoting employee well-being.
Equal Opportunity
Amneal is an Equal Opportunity Employer and does not discriminate based on sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, or any other legally protected status.
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