Regulatory Change Manager

Job Title: Regulatory Change Manager (RCM)

Organizational Relationship(s) including to whom the position reports (JD Job Title):

Position reports into a Line Manager within the Global Regulatory Operations (GRO) - Submissions Management (SM) organization.

Organizational relationships include:

• PGS and R&D (PTx, BTx, PCH) colleagues & functional managers
• GRA and GRO colleagues & functional / regional managers
• CMC Product & Regional Strategists
• External partners, CMOs, CROs, consultant & contracted resources.

Position Purpose

Based within GRO Submission Management, this role sits within a team working to tight, business-critical deadlines within a highly regulated environment.  Primary focus is on allocated products or therapeutic areas, with additional responsibility to support others through utilization of global tools.

Working in partnership with and in support of Regulatory CMC Strategists, this role is responsible for enabling CMC Change Management process and portfolio execution through logistical management and provision of CMC content and deliverables, encompassing regulatory change management compliance, document maintenance and structure.

Primary Responsibilities

Partnering with internal and external partners, the incumbent confirms the appropriate components required to support a CMC change in collaboration with the CMC Strategist and/or RCM Product Manager, confirms and/or establishes CMC content provision timelines and subsequently project manages their delivery to the appropriate colleagues.  In parallel the incumbent assumes responsibility to assure product compliance through timely and accurate maintenance of CMC product information in both CMC change management systems and regulatory planning and document management systems.

CMC change management planning and compilation can take place over days, weeks or months from trigger to completion and will involve coordination with others regarding components and standards required for multiple Boards of Health. Multiple CMC change types at different stages may be managed in parallel, related to product, dossier type or country assignments/requirements. 

To be successful within the role it is expected that the incumbent:

Senior Associate:

• Works with colleagues from multiple regions in order to deliver CMC changes that meet the individual national requirements for which the CMC change leading to a BoH submission is targeted (Asia Pacific, Australia/New Zealand, Africa - Middle East, Europe, East Europe, Latin America and United States)
• Enters and maintains critical regulatory information relating to assigned CMC change management activities within required systems and to required standards and timelines.
• Escalates risks to quality and timelines of CMC changes to strategy, management, or other applicable contact in order to mitigate the risks.
• Facilitates delivery and approval of Pfizer electronic and paper regulatory submissions through co-ordination and execution of CMC components to unique requirements and standards of each submission and national market.
•  Builds knowledge of electronic and paper publishing systems and tools and how these are applied in relation to producing CMC change management outputs; 
• Adheres to the required use of technical tools, through use of working practices and QC/QA regimes, such that regulatory and internal compliance is preserved.
• As required, supports implementation of national and regional process efficiencies and project learning sessions.

Manager (cumulative from above):

• Proactively enters and maintains critical regulatory information relating to assigned CMC change management activities within required systems and to required standards and timelines.
• Through active management of status and expected deliverables, identifies risks and partners with regulatory strategists and relevant stakeholders to mitigate risks to quality and timeliness of CMC changes while ensuring status is accurately reflected at all times through maintenance of metadata in regulatory workflow and/or document management system(s).
• Maintains a working knowledge of electronic and paper publishing systems and tools and how these are applied in relation to producing CMC change management outputs; 
• As required, participates in and/or represents SM in the implementation of national and regional process efficiencies and project learning sessions.
• Demonstration of experience working in a challenging customer service environment

Additional responsibilities for Single Point of Contact (SPOC) (Manager):

• Relevant experience in electronic submissions builds within the Pharmaceutical Industry
• Understanding of existing filing types and components, applicable filing regulatory guidelines and fluency regarding order and presentation of regional and national regulatory dossiers
• Knowledge of drug development process, regulatory affairs, and submissions management
• Understanding of systems and electronic technologies used to support submission and planning activities, as well as demonstrated experiences in process development and new or enhanced technology implementation.

Technical Skill Requirements

Senior Associate (qualitative examples)

• Proven technical aptitude and ability to swiftly learn and apply processes, systems and standards including electronic document maintenance (e.g., Word, Excel, Adobe, Documentum, dossier workflow tools) and other data management tools.
• Ability to successfully plan workload against competing priorities
• Strong communicator, tested excellent verbal and written English language and customer facing skills
• Experience with CMC change management processes/systems and CMC CTD content is essential.
• Proven experience to working within a tightly regulated environment
      
Manager (qualitative examples)

• Strong understanding in identifying and mitigating compliance risks through proper management of CMC product content. 
• Able to build strong global and local networks across functions, lines and zones.
• Ability to work independently is mandatory.  Position receives minimal supervision and guidance and works independently on most projects.
• Experience with CMC regulatory submissions, process development and/or GMP manufacture of clinical and/or commercial products.
• Experience in project management through working submission or CMC change management knowledge gained in Regulatory Operations or Regulatory Affairs

Qualifications (i.e., preferred education, experience, attributes)

• Bachelors level education in pharmaceutical-science or related discipline preferred equivalent relevant professional experience will be considered. 
• 3+ years within the pharmaceutical industry, ideally within Pharmaceutical Sciences, GMP Manufacturing, and/or Regulatory CMC.
• Pharmaceutical industry, specifically Chemistry, Manufacturing and Controls regulatory or quality experience required.
• Require experience with CMC regulatory submissions, process development and/or GMP manufacture of clinical and/or commercial products.
• Experience operating within GMP, GLP, or GCP related SOPs.
• Experience with eCTD publishing, especially Module 3, and workflow management tools
• Knowledge of the CMC business as it relates to drug development, CMC CTD content, and Change Management systems is desired.
• Experience working cross-functionally on broad and strategic initiatives is desired.
• Compliance/Quality experience in pharmaceutical or other regulated industry is desired.
• Lean and/or Six Sigma experience is helpful

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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