Senior Manager - CMC RA Biopharm Development Projects Job Waltham area,Massachusetts USA,Business

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 people's 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. We're uniting science, technology, and talent to get ahead of disease together.

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Our approach to R&D

This position is responsible for leading CMC regulatory activities for investigational, late development and/or early commercial GSK products.

Key Responsibilities:

Drives the CMC strategycoordinatesthetimelypreparationand authors, as needed,technical (CMC) regulatorydocumentstosupport development/registration/lifecycle maintenance submission content,in accordance withthe 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 establishorganisationalnetworks (internal and external understanding departmental constraints/pressure within a highly complex organisation
Engages and may lead CMC Subject Matter Expert activities, both internally (for increased compliance,harmonisation and efficiency) and externally(external advocacy and shapingtheregulatory 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 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.

Basic Qualifications:

Bachelor's degree in Life Sciences or related field.
Four or more years of experience in drug development and manufacturing and supply processes and may have a specialized area of expertise.
Four or more years of experience interpreting and executing complex worldwide CMC regulatory requirements and demonstrated ability to influence the global internal/external regulatory environment.
Two or more years of experience completing project management tasks.

Preferred Qualifications:

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.
Developing experience in major filing activities (MAA/NDA/BLA, significant manufacturing change or key development interactions at EOP2/pre-Phase 3 or other regulatory…