Chemistry & Pharma Regulatory Affairs Job – Genpact
Are you the one we are looking for? Genpact is inviting applications for the role of Lead Associate, Regulatory Affairs. Genpact Pharma and chemistry job opening 2023. Chemistry job opening 2023. Pharma job opening 2023.
You will be responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance and defined regulatory strategies. You will also be responsible for the preparation and review of information required for development of regulatory CMC submission (i.e., US-Annual Reports).
Job Title: Lead Associate- regulatory affairs-LIF009324
Eligbility Criteria
- Bachelor’s or master’s degree (or other advanced degree) preferably in Pharmacy, Chemistry, Nursing or related discipline requirement.
- Bachelor’s degree preferably in Pharmacy, Chemistry, Nursing, or related discipline required related experience in the including research; manufacturing, testing, or licensure of pharmaceutical, vaccine, or biological products; or related fields.
- Alternatively, a master’s or other advanced degree with relevant experience in pharmaceutical industry.
- Excellent organizational skills and a proven ability to multi task.
- Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills.
- Demonstrated understanding of related fields (e.g., Pharmaceutical manufacturing, analytical testing, and quality assurance.) Demonstrated proficiency in REDS or advanced document control system. Superior attentiveness to details.
- Ability to generate innovative solutions to problems and effectively work with and communicate to key stakeholders.
- Flexibility in responding to changing priorities or dealing with unexpected events.
- Capability to handle multiple priorities and balance work to achieve business goals.
- Effective leadership, communication and interpersonal skills.
- Ability to prioritize tasks to meet deadlines and collaborate with a team when help is needed.
- Ability to identify problems and work with team to formulate a potential course of action.
Responsibilities:
- Responsible to provide regulatory filing support for assigned Annual Report by providing required submission activities (compilation of required data (CMC/ancillary documents), coordination, reviewing, and release) in accordance to regulatory requirements and timelines.
- Respond to health authority questions or local subsidiary requests for additional information to support the Annual Reports.
- Administrative Content (Module 1) preparation for Annual Reports-US market.
- To handle Regulatory document management systems: GCM-Trackwise, ORION -COGNOS, VEEVA, REDS, IPI etc.
- Coordination with clients in tracking and status update of project plans.
- Ensure a timely submission of Annual Reports as per the CMC content release date.
Willing to work for US Shift.
Apply Online
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