Career Opportunity: Specialist – Regulatory Affairs Manager at Merck Limited

Established in 1967 as the first Merck subsidiary in Asia, Merck Limited (formerly E. Merck Limited) operates both its Pharmaceuticals and Chemicals businesses in India. As the first Merck Group Company to go public in 1981, the company currently maintains a share capital structure where the Merck Group holds 51%, while the remaining 49% is publicly traded on the Bombay Stock Exchange Ltd.

Job Description & Responsibilities

Dossier Preparation & Compliance: Prepare dossiers and execute actions that support license security, product compliance, and adherence to both company and health authority requirements.
Strategy Alignment: Navigate challenges to help representatives from major disciplines reach agreements on license management strategies and approaches.
Matrix Collaboration: Work within a matrix organization, maintaining extensive communication and collaboration with stakeholders from various functions both within and outside Global Regulatory Affairs.
Task Resolution: Support the resolution of complex tasks under the close supervision and guidance of experienced license management personnel.

Candidate Profile & Qualifications

Experience Required: Minimum of 5 years of overall work experience within a pharmaceutical environment, competent authority, or related R&D/academia experience, with at least 1 year specifically in Regulatory Affairs.
Education: Degree in a Life Science or related discipline, with a Master of Science (MSc) preferred.
Regulatory Expertise: Experience in preparing and managing regulatory documentation, including full international submissions (new product applications) or large variations, along with life-cycle management activities across at least two regions (e.g., Europe, USA, International).
Knowledge Base: Strong understanding of global regulatory affairs, post-approval changes, dossier types, regulatory procedures, supportive registration documents (such as CPPs, GMP Certificates, MLs, PoA’s, etc.), and legalization frameworks.
Core Skills: Ability to interpret international and country-specific regulatory guidelines, maintain strict timeline adherence, proactively communicate risks, and utilize RIM and EDMS RA applications.