Genpact Chemistry/Pharma Job – Candidates Apply Online
Genpact hiring an associate – Regulatory Affairs. Associate – Regulatory Affairs job opening 2023, Pharma job opening 2023, B Pharma job opening 2023, Pharma job opening 2023, Regulatory affairs job opening 2023. Intrested and eligible candidates may check out all the details
Job Title: Associate – Regulatory Affairs-LIF006981
Primary Location India-Mumbai
- Bachelor’s degree, preferably in Pharmacy, Biological Science, Chemistry, Nursing or related discipline required with relevant experience in the pharmaceutical industry.
- Alternatively, a Master’s or other advanced degree, preferably in Pharmacy, Biological Science, Chemistry, Nursing or related discipline required with at least 1 year of relevant experience in pharmaceutical industry.
- Project Management expertise
- Understanding of regulatory requirements
- 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 advanced document management system.
- Superior attentiveness to detail.
- 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
- Responsible to provide regulatory filing support for assigned Submissions by:
- Handling required submission activities (planning, obtaining required data (CMC/ancillary documents), coordination, reviewing, and release) in accordance to regulatory requirements and project timelines
- Responding to health authority questions or local subsidiary requests for additional information to support the Submission
- Responsible to provide support for tracking regulatory submission documents.
- Work closely with various stakeholders to ensure timely follow-ups and receipt of documents for compiling submission packages in electronic/hardcopy format.
- Collaborative interaction to ensure quality, right first-time output and timeliness.
- Monitor document availability status and escalate delays to avoid risk(s).
Setting-up and coordinating meetings and managing submission activities.
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