Specialist - Regulatory Affairs Manager

Role overview

Specialist - Regulatory Affairs Manager at Merck

Responsibilities

• You will support the resolution of complex tasks, under close supervision and guidance provided from the more experienced License management personnel.

Required qualifications

• 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.
• Experience with life-cycle management activities in at least two regions (e.g. Europe, USA, International would be an asset).

Employment details

• Location: Bangalore [Karnataka] [India]

Additional role details

• Your Role.
• The Specialist Regulatory Affairs Manager 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.
• Will be working in a matrix organization, with extensive communication and collaboration with stakeholders from various functions within or outside Global Regulatory Affairs.
• Who You Are.
• Degree in a Life Science or a related discipline, preferably MSc.
• Experience in preparation and management of regulatory documentation, normally a full international submission (new product application) or large variations.
• 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.