Pfizer Pharmaceutical Science Job Opening 2021 – Apply Online
Pfizer Pharmaceutical Science job opening 2021. Candidates with a bachelor’s degree in pharmaceutical science are invited for the post of regulatory manager. Pharma regulatory manager vacancy. Pharma job opening 2021, Pharmacy job 2021. Check out all the details on the same below:
Job Title: Regulatory Change Manager
Location: India – Chennai
- Bachelors level education in pharmaceutical science or related discipline preferred equivalent relevant professional experience will be considered.
- Knowledge of the CMC business as it relates to drug development, CMC CTD content, and
- Change Management systems is desired
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.
- Ability to successfully plan workload against competing priorities
- Strong communicator, tested excellent verbal and written English language and customer-facing skills
- 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 the 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 the 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 timeliness of CMC changes to strategy, management, or another applicable contact in order to mitigate the risks.
- Facilitates delivery and approval of Pfizer electronic and paper regulatory submissions through coordination 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 the implementation of national and regional process efficiencies and project learning sessions.
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