Regulatory Affairs Director for Pharmaceutical Development
2 weeks ago
At 1925 GlaxoSmithKline LLC, we are seeking an experienced Regulatory Affairs Director to join our team. This role offers a competitive salary of $180,000 per annum.
This position is responsible for managing global CMC regulatory activities, from early phase clinical through marketing applications and early lifecycle activities for multiple projects and teams simultaneously.
Key Responsibilities:- CMC Strategy Development: Drives the CMC strategy for camlipixant or similar products, coordinating the timely preparation and authoring, as needed, technical (CMC) regulatory documents to support development/registration/lifecycle maintenance submission content, in accordance with the applicable regulatory & scientific standards, and taking into account the evolving regulatory requirements.
- Risk Management: Identifies risks to the business associated with submission data and information packages and provides and communicates well-defined risk mitigation strategies.
- Team Leadership: Mentors or trains staff. May have direct line management responsibility. Manages project activities for multiple complex projects and teams simultaneously, including those for reporting staff as appropriate.
- Subject Matter Expertise: Engages and may lead CMC Subject Matter Expert activities and typically has deep/specialized area of expertise, both internally (for increased compliance, harmonization, and efficiency) and externally (external advocacy and shaping the regulatory environment).
- Regulatory Strategy: May deliver CMC regulatory strategy to support major inspections (eg PAIs) or quality incidents (PIRCs).
- Submission Content: Has accountability for submission content. Understands, interprets, and advises on regulations, guidelines, procedures, and policies relating to development, registration, and manufacturing of biopharmaceutical products, to expedite submission, review, and approval of global CMC applications.
- Education: Bachelor's degree.
- Experience: 6+ years of regulatory affairs experience.
- Skills: Drug development and manufacturing and supply processes. Negotiating with regulatory agencies, industry bodies, and internal colleagues in a variety of settings.
- Filing Activities: Filing activities (MAA/NDA/BLA, significant manufacturing change or key development interactions at EOP2/prePhase 3 or other regulatory interactions in early development).
We offer a comprehensive benefits package, including medical, dental, and vision coverage, retirement plans, and paid time off.
GSK is an Equal Opportunity Employer and adheres to Affirmative Action principles. We do not accept referrals from employment businesses and/or employment agencies.
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