Pfizer is seeking an experienced Senior Associate I – Regulatory Change Manager for their Chennai location. In this role, you will collaborate with internal and external partners to determine the necessary components to support a CMC/Regional change. Working closely with the CMC/Regional Strategist and/or RCM Product Manager, you will establish timelines for content provision and ensure their efficient delivery to colleagues. Additionally, you will be responsible for maintaining accurate CMC/Regional product information in both CMC/DE change management systems and regulatory planning and document management systems to ensure product compliance.
Here are the key responsibilities of this position:
- Collaborate with colleagues from various regions to deliver CMC changes that meet specific national requirements for BoH submissions in targeted regions such as Asia Pacific, Australia/New Zealand, Africa – Middle East, Europe, East Europe, Latin America, and the United States. Coordinate activities for assigned products and/or necessary CMC change management processes.
- Enter and maintain critical regulatory information related to assigned CMC change management activities within the required systems, adhering to the prescribed standards and timelines.
- Provide operational support to the RCM team for executing designated tasks associated with CMC/Regional colleagues.
- Take accountability for delivering tasks with high quality and within specified timelines, following applicable policies, SOPs/Work Instructions, guidelines, or service level agreements.
- Ensure the appropriate use of technical tools and adhere to working practices and QC/QA regimes to maintain regulatory and internal compliance.
- Identify, escalate, and help resolve any issues that may impact the timeline, quality, or compliance of submissions.
Requirements for the position:
- Possess a Bachelor’s Degree in pharmacy, Biotechnology, or a related scientific field.
- Demonstrated experience of 5+ years working in a tightly regulated environment.
- Relevant experience in electronic submissions within the Pharmaceutical Industry.
- Proven ability to coordinate activities within a highly regulated environment.
- Demonstrated experience in working in a challenging customer service environment.
- Knowledge of the drug development process.
- In-depth understanding of systems and electronic technologies used for submission and planning activities, along with experience in process development and implementing new technologies.
- Ability to effectively plan workload in the face of competing priorities.
- Experience with CMC change management processes/systems and CMC CTD content is essential.
- Familiarity with eCTD publishing, particularly Module 3, and proficiency in workflow management tools.
- Strong command of spoken and written English.
- Demonstrated technical aptitude and the ability to quickly learn and apply processes, systems, and standards, including electronic document maintenance (e.g., Word, Excel, Adobe, Documentum, dossier workflow tools), as well as other data management tools.
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