Job title: Lead Consultant – Regulatory Affairs

Company: Genpact

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 Lead Associate or Lead Consultant, Regulatory affairs.
In this role, you are responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance, and defined regulatory strategies along with the preparation and review of the information required for the development of regulatory CMC dossiers for commercial products.
Responsibilities:

• Responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance and defined regulatory strategies along with the preparation and review of information required for development of regulatory CMC dossiers for commercial products.
• · Work on authoring CMC documentation for worldwide marketing of pharmaceutical products for initial registration and life-cycle management under direction of team scientists.
• · Experience in reviewing scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data.
• · Able to prioritize & execute the project according to the project plan/timelines/schedules.
• · Work with cross-functional teams to track and follow up outstanding documentation, coordinate on project status & reporting to stakeholders using different communication channels.
• · 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).
• · Ability to generate innovative solutions to problems and effectively collaborate with and communicate to key stakeholders.
• · Active participation in departmental improvement activities such as system modifications, maintenance of standard operating procedures, internal guidelines, etc.
• · Demonstrated flexibility in responding to changing priorities, multi-tasking and dealing with unexpected events.
• · Effective leadership, communication, and interpersonal skills.
• · Advanced knowledge of MS Office.
• · Superior attentiveness to detail.

Qualifications we seek in you!
Minimum Qualifications

• Bachelor’s or master’s degree required in science, engineering or related field (advanced degree preferred).

Preferred Qualifications

• Effective leadership, communication, and interpersonal skills
• Advanced knowledge of MS Office
• Superior attentiveness to detail

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.

Expected salary:

Location: Mumbai, Maharashtra

Job date: Thu, 01 Sep 2022 03:28:02 GMT

Apply for the job now!