Specialist – Regulatory Affairs Manager
291311
Bangalore, Karnataka, India
Full-time
At Merck, we are driven by curiosity and a desire to enrich lives through innovation in Healthcare, Life Science, and Electronics. We believe in creating meaningful impact by caring for people, patients, and the planet. Join us to be a part of a global team that imagines the unimaginable and works to make it a reality.
As a Regulatory Affairs Manager (Specialist – License Management), you will:
Prepare regulatory dossiers and execute license management actions to ensure product compliance and license security across global markets.
Collaborate in a matrix organization, coordinating with stakeholders across Global Regulatory Affairs and related functions.
Tackle complex regulatory tasks with support and guidance from experienced license management professionals.
Prepare and manage regulatory documentation to support product registrations and lifecycle management (LCM).
Ensure compliance with health authority and internal requirements for all licensing activities.
Coordinate regulatory strategies and actions for post-approval changes and global variations.
Engage with cross-functional teams to define license management strategy and execution plans.
Review and interpret country-specific and international regulatory guidelines to deliver submission-ready documents.
Track and ensure adherence to regulatory timelines, proactively flagging risks.
Support audits and inspections by preparing and maintaining compliance documentation.
Use regulatory systems (RIM and EDMS) for document management and submission tracking.
Degree in Life Sciences or related discipline (preferably MSc)
Minimum 5 years overall experience in the pharmaceutical industry, regulatory authority, academia, or R&D.
Minimum 1 year of experience specifically in Regulatory Affairs.
Proven experience with full international submissions, large variations, and LCM activities in at least two regions (e.g., EU, US; international exposure is an advantage).
Strong knowledge of post-approval regulatory requirements, procedures, and dossier types.
Familiarity with regulatory documentation: CPPs, GMP certificates, MLs, AtOs, AFs, CLs, PoAs, and the legalization framework.
Understanding of submission requirements and supportive documentation for pharmaceutical product registrations.
Proficiency in project management and regulatory data systems (RIM, EDMS).
Excellent documentation and time management skills.
Strong communication and stakeholder management abilities.
Detail-oriented with a focus on regulatory compliance and process efficiency.
Competitive compensation and long-term financial stability benefits.
Medical insurance, health check-ups, and mental wellness support.
Fertility benefits and family support programs.
Generous leave policies for rest and life events.
Flexible working, car benefits, gym memberships, and shopping discounts.
You Apply – Submit your online application for suitable roles.
We Screen – Our recruiters assess your qualifications and fit.
We Assess – Interviews may be held via phone, video, or in person.
Mutual Agreement – We make you an offer if you’re the right fit.
Work Your Magic – Onboarding begins for your new journey at Merck.
Beware of fraudulent job offers claiming to be from Merck. Refer to our official career site to verify the authenticity of all openings.
At Merck, we celebrate diversity and believe that different perspectives drive innovation. We are committed to building a culture of inclusion, belonging, and empowerment, where everyone has an opportunity to grow and work their magic.
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Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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Siliguri |Illinois :
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