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Specialist/ Senior Associate/ Associate Licence Management

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 
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Job Requisition ID:  203012
Location:  Bangalore SBS
Career Level:  C - Professional (1-3 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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