Location (State / UT)
Desired QualificationMaster’s Degree, Bachelor Degree
Salary in (₹)Negotiable
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/or 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.
CMC change management/Regional 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/Regional change types at different stages may be managed in parallel, related to the product, dossier type or country assignments/requirements.
- 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) 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 the 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 the 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 the timeline, quality, or compliance of submissions.
- Bachelor’s Degree in Pharmacy, Biotechnology, or Science background
- Proven 5+ years’ experience 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.