Director, Regulatory Affairs Cmc

7+ years

Not Disclosed

Remote, USA

10 Jan. 17, 2025

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Director of Regulatory Affairs, CMC – GSK
Locations: UK – London (New Oxford Street), Baar Onyx (Belgium), Rixensart (Belgium), UK – Hertfordshire (Stevenage), USA – Pennsylvania (Upper Providence)
Posted Date: November 19, 2024

Are you looking for a pivotal role that allows you to be a key strategic partner representing Global Regulatory activities? If so, the Director of Regulatory Affairs, CMC at GSK might be the perfect opportunity for you.

In this role, you will lead and provide strategic direction for the Chemistry, Manufacturing, and Controls (CMC) team, ensuring the regulatory leadership for investigational, late development, and early commercial biological products. You will guide the development, registration, and lifecycle maintenance of GSK’s medicines, with a focus on supporting new drug applications globally, including in the US and EU.

Key Responsibilities:

Lead and provide regulatory oversight on CMC activities for investigational and early commercial GSK biological products.
Drive the development of CMC strategies and author technical regulatory documents in alignment with evolving global regulatory requirements.
Identify risks to the business related to submission data and create clear risk mitigation strategies.
Serve as a key strategic partner on global Regulatory Networks and Matrix Teams, providing guidance to cross-functional teams, including Biopharmaceutical, Pharma Supply Chain, Clinical Trial Supply, Quality Assurance, and Commercial teams.
Provide regulatory support for major inspections (e.g., PAI) and quality incidents (PIRCs).
Contribute CMC regulatory support to in-licensing and divestment projects.
Ensure all appropriate regulatory aspects are in place for clinical trials, product release, and stability to prevent clinical holds and ensure market supply continuity.

Impact of Decisions:

Advise on regulations, guidelines, and strategies relating to the development, registration, and manufacturing of biopharmaceutical products, accelerating submission and approval processes.
Ensure the CMC regulatory aspects are properly coordinated across teams to support change control requests, including product transfers within GSK or with third parties.
Responsible for ensuring that regulatory information meets regional requirements to maximize manufacturing flexibility and innovation.

Problem Solving:

Lead the formulation of novel approaches and influence key stakeholders to ensure optimal project execution.
Guide senior management on data assessment, conclusions, and the formulation of risk mitigation strategies.
Continuously improve CMC regulatory processes, policies, and systems to enhance efficiency and quality.

Basic Qualifications:

Degree in Biological Sciences.
Significant direct experience in CMC Regulatory Affairs, with expertise in leading strategic activities for investigational and/or early commercial biopharmaceuticals.
Experience in large enterprise companies and managing complex projects.
Extensive experience in new drug applications in the US or EU.
Proven ability to create and execute on CMC regulatory strategy.

Preferred Qualifications:

Advanced degree in Biological Sciences.
Experience leading CMC regulatory projects for biological medicines.
Ability to adapt to changing priorities in a fast-paced environment.
High resilience and flexible thinking in challenging situations.

Why GSK?
At GSK, we unite science, technology, and talent to advance the health of billions of people worldwide. As a global biopharmaceutical leader, we focus on infectious diseases, HIV, respiratory/immunology, and oncology, while continuing to innovate with vaccines and medicines.

Our success is driven by our people. We aim to create an environment where you feel inspired, encouraged, and empowered to reach your full potential. GSK is a place where everyone can thrive – where you can grow, be yourself, and make a difference in the world.

Benefits:
GSK offers a comprehensive benefits program. To learn more, please visit the GSK US Benefits Summary.

Application Instructions:
Apply by December 3, 2024, by submitting your detailed CV or cover letter showcasing your qualifications for this role.

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Director, Regulatory Affairs Cmc

Job Description

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