Merck Regulatory Affairs Manager Job! Life Sciences Apply Now!
Specialist – Regulatory Affairs Manager
Job Id 279902
Bangalore, Karnataka, India
Job Type Full-time
Your Role:
The Specialist, Regulatory Affairs Manager prepares dossiers and executes actions that support the license security and product compliance on the markets, and that meet the 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, Vault and EDMS RA applications
- Excellent written and spoken English language
Job Location:
Electronic City Phase 1 – Bangalore
Link to apply: APPLY ONLINE HERE
Keywords: Specialist Regulatory Affairs Manager, Merck, Healthcare, Life Science, Electronics, Regulatory Affairs, Pharma, License Management, Bangalore. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebo