Senior CMC Regulatory Strategy Manager

Business Introduction
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. Our R&D focuses on discovering and delivering vaccines and medicines combining our understanding of the immune system with cutting-edge technology to transform peoples lives. GSK fosters a culture ambitious for patients accountable for impact and committed to doing the right thing making sure that we focus our efforts on accelerating significant assets that meet patients needs and have the highest probability of success. Were uniting science technology and talent to get ahead of disease together.
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Position Summary
You will lead Chemistry Manufacturing and Controls (CMC) regulatory strategy for development and lifecycle activities. You will work with cross-functional teams across development manufacturing quality and regulatory to prepare submissions and respond to regulatory requests. Your work will directly support timely access to medicines and continued supply for patients. We value clear communicators pragmatic problem solvers and collaborative colleagues who enjoy influencing technical and regulatory decisions.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Drives the CMC strategycoordinatesthetimelypreparationand authors as neededtechnical (CMC) regulatorydocumentstosupport lifecycle maintenance submission contentin accordance withthe applicable regulatory& scientificstandardsand taking into accountthe evolving regulatory requirements. Identifies risks to the business associated with submission data and information packages and provides and communicates well defined risk mitigation strategies.

• 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. Provides strategic direction data assessment and conclusions within and across departments. Able to establishorganizationalnetworks (internal and external) understandingdepartmentalconstraints/pressurewithinahighlycomplexorganization

• Engages and may lead CMC Subject Matter Expert activities both internally (for increased complianceharmonizationand efficiency)and externally(external advocacy and shapingtheregulatory environment).

• May deliver CMC regulatory strategy to support major inspections (e.g. PAIs) or quality incidents (PIRCs).

• 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.

• Ensures all appropriate CMC regulatory aspects for product release are in place to ensure continuity of market supply. Ensures information submitted lifecycle maintenance submissions meets regional requirements allowing maximum Supply/Production/Quality flexibility with minimal unanticipated questions.

• Formulates novel approaches and influences people evaluating/improving CMC Regulatory processes policies and systems to enhance the efficiency and quality of departmental work

• Directs and communicates complex regulatory issues independently across the company and with external agencies and third parties as necessary to influence project and policy issues that are aligned with business needs ensuring optimum position for the company.

• Operates with considerable independence except for matters that affect corporate or agency policies. Rapidly and appropriately communicates sensitive matters or those with potential for high business impact.

• May participate in corporate evaluation and provide CMC regulatory support/advice to in-licensing and divestment projects.

Why You

Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals

• Bachelors degree in life sciences pharmacy chemistry engineering or related field.

• 6 years of CMC regulatory experience in pharmaceutical biologic device or combination product development.

• Experience preparing and contributing to regulatory submissions (CTD modules amendments INDs BLAs/NDAs or equivalents).

• Experience GMP and manufacturing processes and how they relate to regulatory submissions.

• Experience with complex worldwide CMC regulatory requirements and demonstrated ability to influence the global internal/external regulatory environment.

• Experience handling complex global CMC issues through continuous change and improvement.

• Experience in major post approval filing activities (significant manufacturing change or key regulatory interactions in lifecycle management).

Preferred Qualification
If you have the following characteristics it would be a plus

• Advanced degree (Masters or PhD) in a relevant scientific discipline.

• Direct experience leading interactions with U.S. FDA or other global regulatory agencies.

• Experience managing multiple complex projects or supervising small teams.

• Experience with eCTD submissions and regulatory submission tools.

• Prior experience supporting inspections regulatory audits or major filing activities.

• Demonstrated ability to influence stakeholders and drive regulatory solutions in a matrix environment.

• Experience working in cross-functional teams and providing clear regulatory advice to technical colleagues.

• Proven project management and multi-tasking skills.

• Ability to manage and direct multiple projects/teams.

• Track record of effective influencing and negotiating with regulatory agencies industry bodies and internal colleagues personnel in a variety ofsettings.

• Life cycle management experience ideally including previous roles within pharmaceutical and/or vaccines marketed product support.

• 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 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 an organization and has the ability to motivate and lead others.

Work arrangement
This position is hybrid in the United States. Expect a mix of in-office days for team collaboration and remote days for focused work as agreed with your manager.

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If you are based in Cambridge MA; Waltham MA; Rockville MD; or San Francisco CA the annual base salary for new hires in this position ranges $144375 to $240625. The US salary ranges take into account a number of factors including work location within the US market the candidates skills experience education level and the market rate for the addition this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family) retirement benefits paid holidays vacation and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country the relevant compensation will be discussed during the recruitment Salary Range / Fourchette salariale Belgique: EUR 90000 to EUR 150000The annual gross base salary range for new hires in this position is listed above for each applicable location. These ranges take into account a number of factors including the candidates skills experience education level and the market rate for the addition this position may offer an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. More detailed information on the total benefits package will be supplied during the recruitment process. This role is available for applicants from multiple locations and therefore salary ranges for certain locations are also shown. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the candidates skills experience education level and the market rate for the role. Offers are typically made within the advertised range based on the candidates skills experience and qualifications with the upper end generally reserved for highly experienced candidates or other exceptional circumstances aligned with these criteria.

Please visit GSK US Benefits Summary to 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 purpose to unite science technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade as a successful growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory immunology and inflammation; oncology; HIV; and infectious diseases to impact health at scale.

People and patients around the world count on the medicines and vaccines we make so were committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients accountable for impact and doing the right thing is the foundation for how together we deliver for patients shareholders and our people.

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GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race color religion sex (including pregnancy gender identity and sexual orientation) parental status national origin age disability genetic information (including family medical history) military service or any basis prohibited under federal state or local law.

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