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Sr. Manager - Reg. Affairs

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 Senior Manager, Pharma Regulatory affairs! 
The role demands a highly qualified professional who can guide to direct reports typically comprising of first-line managers and supervisors in a highly regulated & process-driven environment.
•    Planning and timely execution of product life cycle management projects like Post-approval CMC changes  
•    Perform technical review or quality checks of submissions for EU variations  
•    Perform technical review of artwork updates for EU variations  
•    Preparation of monthly project metrics to track the project progress, quality of output and timeliness of submissions 
•    Conduct timely project-specific trainings & meetings for smooth running of project and responsible for the overall management of the project 
•    Preparation of bi-weekly Project Updates for Governance meetings with client 
•    Preparation of bi-weekly dashboards 
•    Review of team’s billable hours approve their timesheets and support in the preparation of Invoices 
•    Identify areas for improvements in the 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 for evaluating a team member's project performance, performing appraisals reviews and sharing constructive feedback, etc.
Qualifications we seek in you!
Minimum Qualifications/skills
•    B.Sc. / M.Sc. / B. Pharmacy / M. Pharmacy
•    Excellent verbal and written communication skills
•    Highly experienced user of MS Office
•    Ability to transfer knowledge
•    Ability to engage with people immediately & build Relationship
•    Team management skills and proficiency
•    Good client communication
•    Excellent project management skills
•    Mentoring junior team members 
•    Ability to Manage multiple Priorities
•    Takes ownership of problems and drives solutions
•    Advanced level project management skill
•    Providing coaching & feedback to enhance first line managers and supervisors' performance
Preferred qualifications/skills
•    Excellent Personality
•    Enthusiasm & confidence 
•    Adhere to our principles and values
•    Proven Time Management skills.
•    Organizational Skills
•    Active listening & Resourcefulness
•    Management skills, Leadership, Decision making
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 Follow us on Twitter, Facebook, LinkedIn, and YouTube.

Job: Senior Manager

Job ID: LIF006669

Primary Location: India - Mumbai

Education Level: Bachelor's / Graduation / Equivalent

Job Posting: Jan 7, 2022

Master Skills List: Operations

Job Category: Full Time