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Director, CMC Regulatory Affairs
4 months ago
Job Purpose:
Leads CMC regulatory activities in the global lifecycle management of GSK biopharmaceutical products. Management oversight for a team ensuring compliance with GSK policies and procedures, staff development and training to deliver roles.
Key Responsibilities:
Represents Global CMC Regulatory, on Regulatory Networks and Matrix Teams providing and overseeing strategic direction and guidance to Supply Chain, Quality Assurance, 3rd Party Contract Management, Commercial and wider GRA on both global project and key strategic business initiatives.
Identifies key risks to the business associated with submission strategy and information packages and provides and communicates to senior management well defined risk mitigation strategies.
Likely to have direct line management responsibility. Coaches and mentors staff across CMC RA on lifecycle management in CMC.
Responsible for managing budget and resource for their teams. Responsible for team compliance with GSK policies and procedures, staff development and training to deliver roles.
Has effective organisational (internal and external) networks. Leads influences and motivates staff within and across departments.
Commercially astute and organisationally aware and able to deal with sensitive and confidential issues. May participate in corporate evaluation and provide CMC regulatory support/advice to in-licensing and divestment projects.
Delivers CMC regulatory strategy to support major inspections (e.g. PAI's) or quality incidents (LICs/PIRCs).
Likely to be involved in and lead current, business critical activities across internal and external networks on behalf of the company. Leads the company position to influence the internal/external CMC Regulatory environment through specialist areas of intelligence.
Has accountability for submission content. Understands, interprets, and advises on regulations, guidelines, procedures, policies, and strategies relating to development, registration, and manufacturing of pharmaceutical products, to expedite submission, review, and approval of global CMC applications in alignment with regional requirements.
Directs resources (across multiple projects and teams simultaneously) to ensure all appropriate CMC regulatory aspects across teams to support license maintenance and change control requests including transfer of supply within the company or with a 3rd party are delivered to agreed timelines.
Formulates novel approaches and influences people, evaluating/improving CMC Regulatory processes, policies, and systems to enhance the efficiency and quality of departmental work.
Operates with independence. Directs and communicates complex regulatory issues independently at senior levels across the company and with external agencies and third parties as necessary, to influence CMC project and policy issues that are aligned with business needs ensuring optimum position for the company.
Basic Qualifications:
BSc in Life Sciences or related scientific discipline with 5+ years of Post Approval CMC Regulatory experience for biopharmaceutical products
Experience in leading major post-approval filing activities for biopharmaceutical products (e.g. significant manufacturing change and key regulatory interactions in lifecycle management)
Experience in biopharm drug development and manufacturing and supply processes.
Experience working with complex worldwide CMC regulatory requirements.
Project management skills.
Effective influencing and negotiating experience with regulatory agencies, industry bodies, and personnel within the company in a variety of settings.
Experience handling complex global CMC issues through continuous change and improvement.
Preferred Qualifications:
PhD in Life Sciences or related scientific discipline.Life cycle management experience ideally including previous roles within pharmaceutical and/or vaccines product support.
Demonstrated ability to influence the global internal/external regulatory environment in the biopharm space.
Continued professional growth in global regulatory affairs including communication of evolving/emerging trends and policies.
Has identified opportunities to further educate colleagues and formulate approaches to most effectively meet new requirements.
Identified as CMC Regulatory expert in a specific subject area.
Proven experience in supervising and training staff within and across the organisation.
Able to demonstrate the following key high-performance behaviours: customer driven, flexible thinking, and continuous improvement.
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Why GSK?
Uniting science, technology and talent to get ahead of disease together.
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).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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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