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
Lead Associate, Regulatory affairs! In this role, you are encouraged to have good knowledge of Planning and timely execution of product life cycle management projects. We are looking for some who should be open to work in any shift as per the business requirement.
The Role demands for a highly qualified professional who can provide mentorship to direct reports typically comprising of first line managers and supervisors. Senior Manager will be responsible for all the activities related to –
- Planning and timely execution of product life cycle management projects like Product License Renewals and Post approval CMC changes
- Perform technical review or quality checks of Product license renewals for EU & ROW markets for Small molecules & Biologicals
- Provide regulatory leadership as needed for efficient management of product license renewal project as well other associated regulatory projects
- Conduct timely project specific trainings & meetings for smooth running of project and responsible for overall management of the project
- Preparation of Bi-weekly Project Updates for Governance meetings with client
- Preparation and review of monthly project metrics and bi-weekly dashboards
- Perform review of team’s billable hours, approve their timesheets and support in preparation of Invoices
- Identify areas for improvements on current project process and documentation of the same after successful discussion and implementation
- Meets client expectations on results output with respect to project timeliness and quality accuracy
- Responsible to evaluate team members project performance, perform appraisals reviews and sharing constructive feedback, etc.
- Analytical Bend of Mind for Client reporting & dashboards.
- Ability to engage with people immediately & form relationship across all level of business.
- Team Management & leadership skills and Proficiency.
- Excellent project management skills.
- Takes Ownership of problems and drives solutions
- Competence to build and effectively lead good rapport across global project teams.
- Providing Coaching & Feedback to enhance first line managers and supervisors performance.
- 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, problem solving skills
- Ability to balance customer governance meetings
- Able to nurture robust working relationships with the team, peers and clients, scheduling flexibility required
- Overall candidate should have problem solving, macro-level research and analytics approach and good 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