Senior CMC Regulatory Leader – Vaccines & Biopharm

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.

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

• Drive the CMC strategy, coordinate the timely preparation and author, 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.
• Identify risks to the business associated with submission data and information packages and provide and communicate well defined risk mitigation strategies.
• Mentor or train staff. May have direct line management responsibility.
• Manage project activities for multiple complex projects and teams simultaneously, including those for reporting staff as appropriate.
• Provide 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 organisation).
• Engage and may lead CMC Subject Matter Expert activities, both internally (for increased compliance, harmonisation 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).
• Have accountability for submission content.
• Understand, interpret and advise 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.
• Ensure 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.
• Ensure information submitted in clinical/marketing applications/lifecycle maintenance submissions meets regional requirements, allowing maximum supply/production/quality flexibility with minimal unanticipated questions.
• Formulate novel approaches and influence people, evaluating/improving CMC Regulatory processes, policies and systems to enhance the efficiency and quality of departmental work.
• Direct and communicate 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.
• Operate with considerable independence, except for matters that affect corporate or agency policies.
• Rapidly and appropriately communicate 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.

• 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.

• 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 interactions in early development).
• Development experience ideally including previous roles within pharmaceutical and/or vaccines product development.
• Significant experience in pharmaceutical industry or research organisations, 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.

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 $144,375 to $240,625. In addition, this position offers an annual bonus and eligibility to participate in our share-based long term incentive programme 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.

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.