Senior CMC Regulatory Strategy Manager

GSK•Waltham, PA

6d•Hybrid

About The Position

This role leads Chemistry, Manufacturing and Controls (CMC) regulatory strategy for development and lifecycle activities. The position involves working with cross-functional teams across development, manufacturing, quality, and regulatory to prepare submissions and respond to regulatory requests. The work directly supports timely access to medicines and continued supply for patients. The company values clear communicators, pragmatic problem solvers, and collaborative colleagues who enjoy influencing technical and regulatory decisions. This role offers the opportunity to lead key activities to progress one's career.

Requirements

Bachelor’s 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).

Nice To Haves

Advanced degree (Master’s 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 of settings.
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.

Responsibilities

Drives the CMC strategy, coordinates the timely preparation and authors, as needed, technical (CMC) regulatory documents to support 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 organizational networks (internal and external) understanding departmental constraints/pressure within a highly complex organization.
Engages and may lead CMC Subject Matter Expert activities, 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 (e.g. PAI's) 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.