Technical Associate - Regulatory Affairs
- Genpact India
- 2 to 4 Yrs
- Mumbai
- 3 years ago
- Email to a friend
- Report this job
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 Technical Associate, Regulatory affairs In this role, you will be responsible to work on deadlines, in a fairly high pressure business environment while being a good team member. You should have the ability to work well in cross-functional teams, exhibiting a combination of active listening skills and the confidence to guide decision-making for the document content strategy.
ResponsibilitiesThe Role demands for a highly qualified professional who should have CMC experience under regulatory affairs domain. BA will be responsible for all the activities related to
- Provide input to project regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements and critically evaluating supporting documentation to assess acceptability and identify potential risks.
- Execute regulatory strategies by leading the development, authoring and review of CMC submission components and documentation to support post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems.
- Collaborate closely with MMD and partners to support compliant execution of organizational change and conduct all activities with an unwavering focus on regulatory conformance.
- Assess and communicate potential regulatory risks and propose mitigation strategies.
- Deliver all regulatory results for assigned products across the product lifecycle
- Identify and communicate potential regulatory issues to GRACS CMC, as needed
- Demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance).
- Proven ability to generate innovative solutions to problems and effectively work with and communicate to key partners.
- Proven flexibility in responding to changing priorities or taking care of unexpected events.
- Capability to handle multiple priorities and balance work to achieve business goals.
- Bachelor s degree in pharma / Science
- Strong financial analytical skills and problem solving skills.
- Effective communicate in writing and verbally to senior management.
- Experience in balancing customer facing role and work assessments.
- Self-starter and have analytical, prioritization skills
- Ability to balance customer governance meetings
- Able to further working relationships with the team, peers and clients, scheduling flexibility required
- Overall candidate should have decision-making, research and analytics approach and in numbers.
- Good people and customer handling skills.
- Effective communication and interpersonal skill.
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 - Software
Role Category: IT Operations / EDP / MIS
Functional Area: Not Applicable
Role/Responsibilies: Technical Associate - Regulatory Affairs
Contact Details:
Company: Genpact IndiaLocation(s): Mumbai
Similar positions
Genpact India
Genpact (NYSE: G) is a global professional services firm focused on delivering digital transformation for our clients, putting digital and data to work to create competitive advantage. We do this by integrating lean principles, design thinking, analytics and digital technologies with our domain and ...
Job Listings
We are in open beta version of website, please let us know if any issues, at: info(at)indigojobs.in
