Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support.
Post : Regulatory Change Manager
• 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)
• 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.
• 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
• 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 Qualifications
• 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.
Qualification : B.Pharm
Location : Chennai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory
End Date : 30th May, 2021
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