Manager/Associate Director, CMC Regulatory Affairs

Site Name: USA - Pennsylvania

• Upper Providence, GSK House

Posted Date: Jun 11 2024

Does leading and delivering Chemistry and Manufacturing Controls regulatory strategy interest you? If so, this role may be for you!

As Regulatory Affairs

• Chemistry, Manufacturing and Controls (CMC) Manager, you will be responsible for managing global CMC regulatory activities, from early phase clinical through marketing applications and early lifecycle activities for multiple projects and teams simultaneously. You will interpret and advise teams on global guidelines, procedures and policies relating to development, registration and manufacture of new pharmaceutical products, responding readily to changing events and priorities.

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 strategy for camlipixant or similar products coordinates the timely preparation and authors, as needed, technical (CMC) regulatory documents to support development/registration/lifecycle maintenance submission content, in accordance with the applicable regulatory & scientific standards, and taking into account the 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 establish organisational networks (internal and external understanding departmental constraints/pressure within a highly complex organization.

• Engages and may lead CMC Subject Matter Expert activities and typically has deep/specialized area of expertise, both internally (for increased compliance, harmonization and efficiency) and externally (external advocacy and shaping the regulatory environment).

• May deliver CMC regulatory strategy to support major inspections (eg 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. Typically has significant experience managing complex regulatory strategies.

• Ensures all appropriate CMC regulatory aspects for clinical trials/product release are in place, to avoid clinical holds and/or to ensure continuity of market supply. Ensures information submitted in clinical/marketing applications/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 Comfortable taking opposing views/position and can do so assertively, but not aggressively and can provide rationale for position with data/precedent/guidance; evaluates data and environment objectively.

• Directs and communicates complex regulatory issues independently 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.

• 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 Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor's degree.

• 6 + years of regulatory affairs experience.

• Drug development and manufacturing and supply processes.

• Negotiating with regulatory agencies, industry bodies, and internal colleagues in a variety of settings.

• Filing activities (MAA/NDA/BLA, significant manufacturing change or key development interactions at EOP2/prePhase 3 or other regulatory interactions in early development).

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Master of science degree or PhD.

• Knowledge and experience of camlipixant development history and regulatory submissions and strategy.

• Development experience ideally including previous roles within pharmaceutical and/or vaccines product development.

• Significant experience in Pharmaceutical industry or Research organizations, established in Regulatory Affairs and with demonstrated experience of team leadership .

• 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.

• 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.

• Typically has significant line management expertise across multiple or multifunctional teams.

• Typically has significant experience managing agency interactions.

• Experience communicating with senior stakeholders.

• Excellent oral and written communication skills.

#LI-GSK

Why GSK?

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 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.

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