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Team Lead - Document and Submission Management


Team Lead role for managing a team of GRA document and submission management experts at Global Regulatory Affairs (GRA) Operations in India/Bangalore.


•Responsible for leading all operational document and submission management activities offshored by GRA Operations/RPSM to GRA Ops India (SBS).
•Processes routine submissions for development products during the product lifecycle in cooperation with the Regulatory Project Manager and TA responsible.
•Ensure sustainability of knowledge, capability and capacity required for the book of work.
•Training coordination, including onboarding of new hires and coach and mentor the people in the offshore site.
•Co-ordinate with SBS Leadership, Facilities and IT teams and ensure availability of all necessary infrastructure, both in terms of office space as well as IT needs.
•Ensure delivery of high-quality submission- and document management services, performance, and value in the business of executing GRA programs and projects.
•Act as the primary point of contact internally with key stakeholders/requestors of GRA Operations/RPSM.
•Resolve and address operational issues and respond to queries from RPSM and its stakeholders.
•Provide monthly reports summarizing team activities, operational highlights and progress.
•Ensure budget adherence.
•Together with GRA-Ops, establish KPIs and ensure adherence to them, incl. proper communication to GRA-Ops functions




•Degree in a Life Science or related discipline.
•Minimum 5 year experience in Regulatory Affairs/Regulatory Operations environment (publishing, submission management).
•Excellent spoken and written English.
Professional skills and experience:
•Proven ability to handle software and databases needed to support the regulatory function according to the role.
Personal skills and competencies:
•Expert level proficiency and expertise in problem solving.
•Advance proficiency in interpersonal skills, management of stakeholders, and impactful communication.
•Excellent organizational skills, work independently, self-motivated and proactive.
•Meticulous working style and highest quality awareness. Master's degree/PhD in Organic Chemistry or related field. Knowledge of green chemistry and recent trends in the field is required.




Job Requisition ID:  192061
Location:  Bangalore SBS
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.

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