1+ months

Assistant Manager

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**Primary Responsibilities:** The following outlines CMC Change management activities required for managing compliance, coordinating, creating, and delivering CMC content for onward provision to Boards of Health (BoH).

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:

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)

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).

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.

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;

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, participates in the implementation of national and regional process efficiencies and project learning sessions.

**Technical Skill Requirements**

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.

Experience with CMC change management processes/systems and CMC CTD content is


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.

Aptitude for customer service, facilitation, and conflict resolution, approaching all situations with enthusiasm and integrity, despite demanding workload, technical barriers and changing deadlines and requirements.

Ability to work independently is mandatory. Position receives minimal supervision and guidance and works independently on most projects.

Ability to successfully plan workload against competing priorities

Require experience with CMC regulatory submissions, process development and/or GMP manufacture of clinical and/or commercial products.

Proven experience to working within a tightly regulated environment

Strong communicator, tested excellent verbal and written English language and customer facing skills

Experience in project management through working submission or CMC change management knowledge gained in Regulatory Operations or Regulatory Affairs

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

Regulatory Affairs
Posted: 2019-12-23 Expires: 2020-04-27

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