Project Manager, CMC Regulatory Affairs

Project Manager, CMC Regulatory Affairs

Responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products.

Key Responsibilities

• Responsible for the global CMC regulatory activities for assigned projects and responds readily to changing events and priorities.
• Responsible for CMC strategy development, with managerial support, for CMC submission documents from early phase clinical submissions (IND/IMPD) through to marketing applications (NDA/BLA/MAA) and early lifecycle management activities in accordance with applicable regulatory & scientific standards.
• Understands, interprets and will sometimes advise teams on regulations, guidelines, procedures and policies relating to development, registration and manufacture of medicinal products, to expedite the 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 meets regional requirements, allowing maximum Supply/Production/Quality flexibility with minimal unanticipated questions.
• Works in cross functional matrix project teams, which include colleagues from regulatory, development, quality and manufacturing ensuring adequate interaction and partnership in order to define proper regulatory CMC filing strategy.
• Maintains high quality standards and seeks to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment.
• Ensures regulatory compliance is maintained and shares best practices and learnings within the CMC Regulatory teams and other impacted functions.
• Engages in CMC Subject Matter Expert activities internally (for increased compliance, harmonisation and efficiency).
• Will sometimes deliver CMC regulatory strategy to support major inspections (e.g. PAIs) with managerial support.

Required Skills and Qualifications

• Chemistry, Manufacturing and Controls (CMC) regulatory affairs or product development experience with direct involvement in regulatory submission preparation across all stages of development through to early life cycle submissions.
• Degree in life sciences or related scientific discipline.
• Sound knowledge of drug development, manufacturing processes and supply chain and may have a specialized area of expertise.
• Knowledge of worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for new medicines in development.
• Good time management skills with the ability to effectively plan, prioritise and coordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines.
• Demonstrated knowledge of all relevant components of project management, including management of scope, time, cost, quality, integration, influence & negotiation, communications, risk, and scenario planning across all project management focus areas, namely initiating, planning, executing, monitoring, controlling, and closing of projects (i.e. strong theoretical knowledge).

Benefits

• Career at one of the leading global healthcare companies.
• Contract of employment.
• Attractive reward package (annual bonus & awards for outstanding performance, recognition awards, holiday benefit).
• Hybrid working model.
• Extensive support of work life balance (flexible working solutions, minimum 2 3 days/week working from the office, health & well being activities).
• Life insurance and pension plan.
• Private medical package with additional preventive healthcare services for employees and their eligible families.
• Sports cards (Multisport).
• Possibilities of development within the role and company's structure.
• Personalized learning approach (internal trainings, mentoring, access to online training platforms: Keep Growing Campus, LinkedIn Learning, Business Skills, Harvard Manage Mentor, Skillsoft and external training).
• Supportive community and integration events.
• Modern office with creative rooms, fresh fruits every day.

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.