Specialist - Regulatory Affairs Manager

Merck KGaA, Darmstadt, Germany; Bengaluru; On-site; INR 1,800,000 - 2,800,000; Full time

Job summary

Merck KGaA in Bengaluru, India is seeking a Specialist Regulatory Affairs Manager to drive regulatory activities for license security and product compliance. You will prepare regulatory dossiers and coordinate with multiple stakeholders to ensure timely submissions in diverse markets.

The role requires at least five years in pharma/regulatory settings, a life sciences degree (MSc preferred), and hands-on experience with life-cycle management and regulatory guidelines.

Qualifications

• Minimum 5 years of pharma/regulatory experience, including 1 year in regulatory affairs.
• Master's degree in life sciences (preferred MSc).
• Experience with regulatory documentation and international submissions.
• Experience in lifecycle management across multiple regions.
• Strong knowledge of regulatory guidelines and timelines.
• Proactive communicator with good project management.

Responsibilities

• Prepare dossiers and manage actions for license security and product compliance.
• Collaborate with cross-functional teams to align license management strategy.
• Navigate a matrix organization with stakeholders from various functions.
• Support resolution of complex tasks under supervision and guidance.

Skills

Regulatory affairs

Project management

Stakeholder comms

Dossier management

RIM & EDMS RA

Education

MSc Life Science

Tools

RIM

EDMS RA

Job description

Job Description

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimageable with us.

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

Who You Are

• 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
• 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.
• 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.

What we offer

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!