Project Manager, CMC Regulatory Affairs

GSK

19h•Hybrid

About The Position

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. Find out more: Our approach to R&D 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.

Requirements

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 co-ordinate 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).

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 the 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 (eg PAIs) with managerial support

Benefits

Career at one of the leading global healthcare companies
Contract of employment
Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)
Hybrid working model (where GSK site are in Poland)
Extensive support of work life balance (flexible working solutions, min. 2-3 days/week working form the office, health & well-being activities)
Life insurance and pension plan
Private medical package with additional preventive healthcare services for employees and their eligible
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