Senior Manager, CMC Facilities Regulatory Affairs
4 weeks ago
Posted Date: May
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We're uniting science, technology and talent to get ahead of disease together.
The Senior Manager, CMC Facilities Regulatory Affairs will be responsible for regulatory submissions, interactions with FDA, and strategy for various US vaccines regarding manufacturing facilities and equipment aspects.
Management of facilities and equipment matters required for INDs, registration and life cycle for GSK Vaccines products including definition of the proper regulatory filing strategy, file preparation & submission and regulatory authorities' interactions for Assigned Projects/Sites in which GSK vaccines are manufactured.
For US FDA/CBER specific interactions (for instance submissions, consultations...), will function as the "legal agent" regarding Facilities & Equipment CMC submissions and Inspections.
Key Responsibilities:
- Specifically for US function act as "Legal Agent" for CMC Facility specific submissions provides consistent point of contract for FDA to facilitate interactions such as Information Requests/Clarifications.
Interact with internal project related teams, for Facilities related regulatory affairs aspects of a given project on technical aspects. - Participate in project/product-related discussions and provide strategic, scientific and regulatory affairs input, for Facilities related aspects of given project on technical aspects.
- Provide input into the asset specific regulatory strategy on a global scale.
- Provide support to the GRL via input and/or critical review of the facilities regulatory documents, Global Regulatory Plan(s) and/or Key Message Summaries.
- Provide support to the GRL to assure efficient interactions with the regulatory authorities to achieve on-time approvals of GSK Vaccines submissions for the asset(s).
- Write/review/approve regulatory submissions before they are submitted to regulatory agencies, mainly to the US FDA (CBER)
- Assess the regulatory impact of Regulatory Facilities related changes pertaining to approved commercial products.
- Be aware of changes in regulatory guidelines and their impact on regulatory strategy for the particular asset(s).
- The job also includes providing support (coaching, mentoring, lead) to several Managers and Specialists in the team.
Basic Qualifications:
- Bachelor's Degree in Life Sciences or related discipline.
- Five or more years of experience in Regulatory Affairs.
- Three or more years of experience in US FDA regulations pertinent to CMC/Establishments/GMP
- Three or more years of experience in CMC/Establishments/GMP/ Equipment, cleaning, sterilization validations
Preferred Qualifications:
- MS or PhD. In Life Sciences or related field.
- Pharmaceutical development or regulatory affairs experience with biologics and vaccines preferred.
- Experience in providing strategic advice on integrated regulatory development plans and life cycle management, preferably for the US. Providing US-focused input into regulatory strategy, evaluating potential impact on overall project/product strategy.
- Proven project management and multi-tasking skills.
- Track record of effective influencing and negotiating with regulatory agencies, industry bodies, and personnel in a variety of settings.
- Experience in understanding, interpreting and advising on regulations, guidelines, procedures, policies and strategies relating to Facilities and Equipment to expedite submission, review and approval of global CMC applications.
- Demonstrated ability to handle complex global CMC Facilities and GMP issues through continuous change and improvement.
- Regulatory CMC (Development or Mature products) and/or QA experience ideally including previous roles within pharmaceutical and/or vaccines product development/manufacturing.
- Continued professional growth in global regulatory affairs including communication of evolving/emerging trends and policies. Has identified opportunities to further educate internal colleagues and formulate company approaches to most effectively meet new requirements.
- Identified as CMC Regulatory expert in a specific subject area.
- Highly developed interpersonal, presentation and communication skills with established internal and external networks.
- Proven experience in supervising and training junior staff within and across the organisation and has the ability to motivate and lead others.
Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees.
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.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at US Toll Free) or outside US).
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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