Pfizer is hiring an experienced Senior Associate I - Regulatory Change Manager at their Chennai location.
SANDEEP KUMAR | May 26, 2023 | Views 4566
Pfizer Hiring Science, Pharma, Biotechnology Graduates
Pfizer is hiring an experienced Senior Associate I – Regulatory Change Manager at their Chennai location. Partnering with internal and external partners, the incumbent confirms the appropriate components required to support a CMC/Regional change in collaboration with the CMC/Regional Strategist and/or RCM Product Manager, confirm and establishes CMC/Regional 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/Regional product information in both CMC/DE change management systems and regulatory planning and document management systems.
The complete details of this job are as follows:
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) along with coordination activities for assigned products and/or at required CMC change management Process as appropriate.
Enters and maintains critical regulatory information relating to assigned CMC change management activities within required systems and to required standards and timelines.
Provide operational support within RCM team to execute designated tasks associated with CMC/Regional colleagues.
Accountable for delivering tasks with quality and timeliness as per applicable policy, SOP/Work Instructions, guidelines, or service level agreement.
Adhere to the appropriate use of technical tools, through use of working practices and QC/QA regimes, such that regulatory and internal compliance is preserved.
Escalate, inform, and/or resolve any issues that may impact timeline, quality, or compliance of submissions.
Bachelor’s Degree in pharmacy, Biotechnology or Science background
Proven 5+ years’ experience to working within a tightly regulated environment.
Relevant experience in electronic submissions build within the Pharmaceutical Industry
Demonstrated coordination of activities in a highly regulated environment
Demonstrated experience working in a challenging customer service environment.
Knowledge of the drug development process
In-depth understanding of systems and electronic technologies used to support submission and planning activities, as well as demonstrated experiences in process development and new technology implementation.
Ability to successfully plan workload against competing priorities.
Experience with CMC change management processes/systems and CMC CTD content is essential.
Experience with eCTD publishing, especially Module 3, and workflow management tools
Good knowledge of English, spoken and written
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.
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