Regulatory Affairs Manager
2 months ago
About the Role:
We are seeking a highly skilled Regulatory Affairs Manager to join our team at 1925 GlaxoSmithKline LLC. As a key member of our CMC Regulatory Affairs team, you will be responsible for ensuring the global regulatory compliance of our products throughout the investigational, late phase development, and early commercial lifecycle management.
Key Responsibilities:
- Develop and implement CMC regulatory strategies for assigned projects, ensuring compliance with global regulatory requirements.
- Collaborate with cross-functional teams to ensure timely and accurate submission of regulatory documents, including IND/IMPD, NDA/BLA/MAA, and marketing applications.
- Provide regulatory guidance and support to teams on regulations, guidelines, procedures, and policies related to development, registration, and manufacture of medicinal products.
- Ensure all CMC regulatory aspects for clinical trials and product release are in place, avoiding clinical holds and ensuring continuity of market supply.
- Work closely with regulatory, development, quality, and manufacturing teams to define proper regulatory CMC filing strategy.
- Maintain high-quality standards and continuously improve performance through innovative approaches in responding to the evolving regulatory environment.
- Ensure regulatory compliance is maintained and share best practices and learnings within the CMC Regulatory teams and other impacted functions.
- Engage in CMC Subject Matter Expert activities internally to increase compliance, harmonization, and efficiency.
Requirements:
- BS in a Life Sciences or related field.
- Two or more years of experience in CMC regulatory affairs or product development with direct involvement in regulatory submission preparation across all stages of development through to early life cycle submissions.
- Two or more years of experience in drug development, manufacturing processes, and supply chain, with a specialized area of expertise.
Preferred Qualifications:
- MS in a Life Sciences or related field.
- RAPS Certification.
- Biologics experience.
- Veeva Vault experience.
- Pre-approval experience (phase 1 to phase 3 submission experience).
- Knowledge of worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for new medicines in development.
About GSK:
GSK is a global biopharma company with a special purpose – to unite science, technology, and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology, and oncology).
Why GSK?
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status, or any other federal, state, or local protected class.
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