Lead Associate - Reg. Affairs
- Genpact India
- 3 to 5 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.
Transformation happens here. Come, be a part of our exciting journey
Are you the one we are looking for
Inviting applications for the role of Lead Associate, Regulatory Affairs
You will be responsible for managing all the activities involved in planning, and dispatching US-Annual Reports.
Responsibilities
Provide regulatory filing support for assigned Annual Report by providing required submission activities (planning, obtaining required data (CMC/ancillary documents), coordination, reviewing, and release) in accordance with 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: ORION -COGNOS, VEEVA, REDS, SPARS, etc.
Coordinate with clients in tracking and status update of project plans.
Ensure timely submission of Annual Reports to the agency.
Coordinate team review, electronic content publishing, and release of the Annual Report submission content.
Qualifications we seek in you
Minimum Qualifications
Bachelor s or master s degree (or another advanced degree) preferably in Pharmacy, Biological Science, Chemistry, Nursing or related discipline requirement
Bachelor s degree preferably in Pharmacy, Biological Science, Chemistry, Nursing, or related discipline required with related experience in the pharmaceutical industry. Alternatively, a master s or another advanced degree with relevant experience in the 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 RCAM or advanced document control system. Superior attentiveness to details
Ability to generate innovative solutions to problems and effectively work with and communicate with 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 the team to formulate a potential course of action
Willing to work for US Shift
Preferred Qualifications / Skills
Demonstrated understanding of regulatory affairs and pharmaceutical registrations
Demonstrated ability to generate innovative solutions to problems and effectively work with and communicate to key partners
Demonstrated flexibility in responding to changing priorities or dealing with unexpected events
Capability to prioritize multiple priorities and balance work to achieve business goals
Demonstrated effective leadership, communication, and interpersonal skills
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: General / Other SoftwareSales / BD Functional Area: Not ApplicableRole/Responsibilies: Lead Associate - Reg. AffairsContact Details:
Company: Genpact IndiaLocation(s): Mumbai
Keyskills: customer relations reporting sla accounts basis handle multiple priorities continuous improvement facilitation annual reports customer focus document control regulatory affairs
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 ...
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