Manages the day-to-day activities along with the regulatory activities associated with projects assigned
Responsible for the deliverables of junior colleagues, in case, assigned
Provides review support and guidance to the team in impact assessment of regulatory changes, preparation of regulatory strategy, and supplement/variation authoring.
Primary accountable for managing multiple projects/ CMC programs of various complexities, managing and ensuring daily delivery of regulatory and strategic activities, and post-approval changes for Brands in collaboration with Global Regulatory Strategists –CMC (GRSs-CMC) assigned to the team.
For individual projects, review proposed changes for completeness and accuracy and development of initial global regulatory strategy while considering registered content and seeking endorsement by the CMC GRL.
Provides adequate support and guidance to the team in terms of being resourceful on technical and regulatory knowledge.
Represents GRA CMC’s point of view and meets with key stakeholders to resolve challenges. Authors and/or compile Regulatory Strategy Documents (RSD) where needed, as well as CMC submission packages globally, i.e. Module 1, Module 2.3, M3.2 S/P/R under guidance from the CMC GRL as appropriate and within agreed timelines.
Major and Emerging Market Focused
Reviews technical/supportive information for submission to support change
Reviews and applies pertinent global regulatory guidelines
Develops technical justification of change for agency submission
Updates M3 dossier
Coordinates M3.2.R Ancillary documents
Flags identified risks to the CMC GRL and/or appropriate leadership
Ensures resolution of issues and manages regulatory risks within the project.
Investigates opportunities for regulatory innovation / promote the use of novel approaches to resolve issues and problems.
Responsible for ensuring compliance with Company’s submission standards, policies, and procedures for self and team.
Contributes to the development of internal policies, processes, and procedures
Remains knowledgeable about current regulations and guidance interprets and notifies appropriate personnel.
Coordinates internal document review and sign-off.
Utilizes Pfizer’s CMC systems, i.e. GDMS, PDM, SPA, etc, as appropriate
Supports Query and/or commitment management in collaboration with CMC Leads
Maintains conformance systems maintenance in support of the CMC Product Leads
Remains knowledgeable about current regulations and guidance interprets and implements in the assigned projects
Qualifications
Must-Have
Master’s Degree
7+ years of experience
Industry experience in Regulatory Affairs and/or Clinical Trial Management
Knowledge of the regulatory environment and how this impacts regulatory strategy development and implementation
Proven ability to consistently deliver to time, cost, and quality standards
Strong problem-solving skills and team orientation
Excellent written and verbal communication skills
Good knowledge of Windows and Microsoft Office
Nice-to-Have
Master’s degree
Relevant pharmaceutical experience
Awareness of and ideally experience in successfully communicating with Health Authorities
Familiarity with pharmaceutical organizational structures, systems, and culture
