Lead Associate - Reg. Affairs
- Genpact India
- 3 to 8 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 of Management Trainee, Regulatory affairs
You shall be responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance and defined regulatory strategies along with the preparation and review of information required for development of regulatory CMC dossiers for commercial products.
Responsibilities:
Identify the regulatory submission requirements, based on regulatory guidelines.
Liaise with local country regulatory teams to verify the submission requirements
Plan the due dates, and coordinate the on-time delivery of the renewal content, to meet regulatory requirements
Review the submission content for accuracy and completion against the submission requirements
Coordinate team review, electronic content publishing, and release of the submission content
Ensure all required submission content is obtained
Support response to health authority questions or local subsidiary requests for additional information to support the submission.
Qualifications we seek in you
Minimum Qualification
Bachelors degree required in science, engineering or related field
Preferred Qualifications
Advanced degree preferred
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: Sales / BDFunctional Area: Not ApplicableRole/Responsibilies: Lead Associate - Reg. AffairsContact Details:
Company: Genpact IndiaLocation(s): Mumbai
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