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Specialist/ Senior Associate/ Associate Licence Management

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Job Number: 2234

External Description: Your Role:

The Specialist Licence Management prepare dossiers and execute actions that support the license security and product compliance on the markets, and that meet company's and health authorities' requirements. Encounter the challenges to enable representatives from all major disciplines involved to reach agreement on the licence management strategy and approach.

Position will be working in a matrix organization, with extensive communication and collaboration with stakeholders from various functions within or outside Global Regulatory Affairs. The role will support the resolution of complex tasks, under close supervision and guidance provided from the more experienced License management personnel

Who You Are:

Experience: Minimum 5 years of overall work experience in Pharma environment, Competent authority or Academia/R&D experience related to the role. Minimum 1 year of Regulatory affairs experience

Education: Degree in a Life Science or a related discipline, preferably MSc

Job Specific Competencies & Skills

  • Experience in preparation and management of regulatory documentation, normally a full international submission (new product application) or large variations
  • Experience with life-cycle management activities in at least two regions (e.g. Europe, USA, International would be an asset)
  • Good knowledge about Regulatory Affairs and specifically post approval changes, regulatory dossier types and main regulatory procedures globally
  • Understanding of supportive documents necessary for the registration and LCM of pharmaceutical products (CPPs, GMP Certificates, MLs, AtO's, AFs, CLs, PoA's etc.) as well as legalization framework
  • Ability to review and interpret country specific and international regulatory guidelines, policies and regulations to generate submission ready deliverables as per request
  • Adherence to agreed timelines and proactive communication of any potential risk to the same
  • Project management and documentation skills, proactive communication approach
  • Contributor level of experience with RIM and EDMS RA applications
  • Excellent written and spoken English language


Job Location:
  • Electronic City Phase 1 - Bangalore


-We have several openings for License Management roles for various levels and profiles.

-Expectations and scope of responsibilities provided in this Job posting are for Specialist level.

-The exact designation to be offered will depend on applicants' experience and knowledge confirmed during the screening process.

Job Requisition ID: 210055

Location: Bangalore

Career Level: C - Professional (1-3 years)

Working time model: full-time

Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone's health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options.

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.

Job Segment: Manager, Pharmaceutical, Project Manager, Management, Science, Technology

Job Number: 210055

Community / Marketing Title: Specialist/ Senior Associate/ Associate Licence Management

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