Manager/Associate Director, Regulatory Affairs CMC

Reference #: 406144
Site Name: USA – Pennsylvania – Upper Providence, UK – Hertfordshire – Ware, USA – Massachusetts – Waltham
Posted Date: Oct 16 2024

Are you interested in a highly-visible US regulatory affairs role that allows you to drive strategy and shape integrated regulatory development across portfolios?  If so, this Regulatory Affairs Management Manager could be an ideal opportunity to explore.

As a Regulatory Affairs Management Manager/Associate Director, you will be responsible for regulatory submissions, interactions, and strategy related to products within the US.

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 needed,technical (CMC) regulatorydocumentstosupport development/registration/lifecycle maintenance submission content,in accordance withthe applicable regulatory& scientificstandards,and 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 establishorganisationalnetworks (internal and external understanding departmental constraints/pressure within a highly complexorganisation

Engages and may lead CMC Subject Matter Expert activities, both internally (for increased compliance,harmonisationand efficiency)and externally(external advocacy and shapingtheregulatory 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.

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

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:
Bachelors Degree in Life Sciences or associated discipline
Experience in drug development and manufacturing and supply processes and may have a specialized area of expertise.
Experience with complex worldwide CMC regulatory requirements and demonstrated ability to influence the global internal/external regulatory environment.
Developing experience in major filing activities (MAA/NDA/BLA, significant manufact ring 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:
PhD in Life Sciences or associated discipline
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 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 organisation and has the ability to motivate and lead others.
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 of settings
Demonstrated ability to handle complex global CMC issues through continuous change and improvement.

#LI-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, its 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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