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Manager - Regulatory 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?
Inviting applications for the role of Manager, Regulatory Affairs 
The Regulatory Affairs (RA) Manager is responsible for maintaining or obtaining Health Authority (HA) approval for our client’s pharmaceutical portfolio. They will guide regulatory strategy in line with regional, national, and international requirements and establish dossier timelines from authoring through to submission and approval at the HA. They will be responsible for end-to-end management of regulatory submissions including Planning, module 1, 2 & 3 authoring/review/publishing & dispatch. In parallel, the person assumes responsibility to assure dossier status through timely and accurate maintenance of dossier information in regulatory planning and document management systems.

Responsibilities
•    Work with colleagues from multiple regions to deliver a dossier that meets the technical requirement (such as but not limited to eCTD, NeES and Paper) and regional/local regulatory requirements for which the submission is targeted (the Asia Pacific, Australia/New Zealand, Africa - Middle East, Europe, East Europe, Latin America and the United States)
•    Proactively enters and maintains critical regulatory information relating to assigned submissions within required systems and to required standards and timelines
•    Through active management of status and expected deliverables, identify risks and formulates a strategy to mitigate those risks to quality and timeliness of submissions
•    Deliver electronic and paper regulatory submissions through coordination and execution to requirements and standards of each submission and national markets
•    Maintains a working knowledge of electronic and paper publishing systems and tools and how these are applied; fluency with multiple dossier formats and translation requirements as required
•    Assist with the interpretation of regulatory technical guidelines to produce business requirements and ensure that those requirements are implemented where appropriate at local level
•    Adhere to the required use of technical tools, through use of working practices and QC/QA regimes, such that regulatory and internal compliance is preserved.
•    Manage and lead a team Reg Affairs professionals to deliver quality, first-time-right, regulatory content
•    Project manages a team to ensure deliverables and service levels are met and within the agreed timelines.
•    Work with the client to develop a clear and detailed plan for reporting metrics
•    Act as the liaison/single point of contact to the client for all process-related items and participate in client governance meetings regularly


Qualifications we seek in you!
Minimum qualifications/skills
•    Bachelor's degree required in science, engineering or related field (advanced degree preferred)
Preferred qualifications/skills
•     Relevant experience in global regulatory affairs and regulatory operations. Proven success in compiling and filing regulatory submissions and Marketing Authorizations end to end
•     Proven and relevant regulatory affairs experience in the pharmaceutical, vaccine, or biological products; or related fields
•     Proven experience in managing a regulatory team successfully, including duties such as providing regulatory strategy and guidance, reporting, tracking SLAs, training, and managing client/pharma company expectations
•     Demonstrated superior oral and written communication skills in multicultural settings and the ability to communicate complex issues succinctly and logically.  Good listening skills
•     Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate with key stakeholders
•     Demonstrated flexibility in responding to changing priorities or dealing with unexpected events
•     Demonstrated effective leadership, communication, interpersonal, and negotiating skills  
•     Ability to prioritize tasks to meet deadlines and collaborate with a team when help is needed
•     Skilled at fostering customer relationships and driving collaboration

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, client focus, and innovation. For more information, visit www.genpact.com. Follow us on Twitter, Facebook, LinkedIn, and YouTube.


 

Job: Manager

Job ID: LIF006744

Primary Location: India - Mumbai

Education Level: Bachelor's / Graduation / Equivalent

Job Posting: Jan 18, 2022

Master Skills List: Operations

Job Category: Full Time