Lead Associate - Regulatory Affairs
- Genpact India
- 3 to 4 Yrs
- Mumbai
- 4 years ago
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Job Description
*With a startup spirit and 90,000+ curious and courageous minds, we have the expertise to go deep with the world s biggest brands and we have fun doing it. Now, we re calling all you rule-breakers and risk-takers who see the world differently, and are bold enough to reinvent it. Come, transform with us.
Are you the one we are looking for
We are inviting applications for the role Regulatory affairs
In this role, you will be responsible to Identify the regulatory requirements, based on regulatory intelligence database.
Responsibilities:
Identify the regulatory requirements, based on the regulatory intelligence database.
Serve as the Submission Lead for assigned products and be accountable for the delivery of renewals.
Liaise with local country regulatory teams to verify the requirements.
Lead development and execution of global product and project regulatory strategy by ensuring proper planning for submission, identification of global regulatory requirements, and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks.
Plan the due dates, and coordinate the on-time delivery of the variation content, to meet regulatory requirements.
Preparation of Cover letter, Table of content, Application form along with the annexes.
Review the variation content for accuracy and completion against the variation requirements
Coordinate team review, electronic content publishing, and release of the variation submission content
Ensure all required variation content is obtained
Support response to health authority questions or local subsidiary requests for additional information to support the variation.
Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval and Product supply continuity.
Assess and communicate potential regulatory risks and propose mitigation strategies.
Deliver all regulatory milestones for assigned products across the product lifecycle
Qualifications we seek in you
Minimum Qualifications
Bachelors required in science, engineering, or related field (advanced degree preferred)
Preferred Qualifications/Skills
Masters degree
Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values diversity and inclusion, respect and integrity, customer focus, and innovation. For more information, visit www.genpact.com. Follow us on Twitter, Facebook, LinkedIn, and YouTube.
Employement Category:
Employement Type: Full timeIndustry: IT - SoftwareRole Category: IT Operations / EDP / MISFunctional Area: Not ApplicableRole/Responsibilies: Lead Associate - Regulatory AffairsContact Details:
Company: Genpact IndiaLocation(s): Mumbai
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