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Job Opportunity: Specialist – Regulatory Affairs Manager at Merck- Apply before 20th April 2025

Merck Limited
Pharmacareer

Website Merck

Location: Bangalore, Karnataka
Industry: Pharmaceuticals / Healthcare / Clinical Research
Experience: Minimum 5 years
Qualification: Degree in Life Sciences, preferably MSc
Application Deadline: April 20, 2025

About Merck

Our commitment to science and technology drives our 63,000 employees across 65 countries to develop solutions for some of today’s toughest challenges. We are dedicated to improving lives—delivering personalized treatments for serious diseases, supporting scientific breakthroughs, and ensuring the safety and accuracy of medicines. As a global leader, we empower the scientific community with advanced tools, services, and digital platforms that accelerate access to healthcare solutions.

Job Overview

We are seeking a Specialist – Regulatory Affairs Manager to support regulatory compliance and license security for our pharmaceutical products. This role involves preparing dossiers, managing regulatory submissions, and collaborating with stakeholders to ensure compliance with global health authorities. The successful candidate will work in a matrix environment, engaging with multidisciplinary teams to navigate complex regulatory challenges.

Key Responsibilities

  • Prepare and manage regulatory documentation, including full international submissions and major variations.

  • Oversee life-cycle management activities across multiple regions (e.g., Europe, USA, International).

  • Ensure compliance with global regulatory procedures and post-approval changes.

  • Manage country-specific and international regulatory requirements, including Certificates of Pharmaceutical Product (CPPs), GMP Certificates, Marketing Authorizations, and other essential documents.

  • Interpret and apply international regulatory guidelines and policies to generate submission-ready deliverables.

  • Maintain adherence to agreed timelines and proactively communicate potential risks.

  • Utilize regulatory information management systems (RIM), Vault, and electronic document management systems (EDMS).

  • Collaborate cross-functionally to support regulatory strategy and execution.

Skills & Competencies

  • Strong expertise in regulatory affairs, dossier preparation, and life-cycle management.

  • Familiarity with global regulatory procedures and documentation requirements.

  • Excellent project management and organizational skills.

  • Proficiency in regulatory software applications.

  • Exceptional written and verbal communication skills in English.

Candidate Profile

  • Education: Degree in Life Sciences or a related field (MSc preferred).

  • Experience:

    • Minimum 5 years of industry experience in the pharmaceutical sector, regulatory authorities, or academic/research institutions.

    • At least 1 year of experience in regulatory affairs.

Why Join Us?

  • Be part of a globally recognized organization that pioneers advancements in healthcare and technology.

  • Work in an innovative and collaborative environment with industry experts.

  • Contribute to meaningful projects that improve lives worldwide.

If you are passionate about regulatory affairs and meet the qualifications, we invite you to apply!

To apply for this job please visit careers.emdgroup.com.