Global CMC Regulatory Specialist At Merck

Are you ready to work your magic and make a global impact? We are seeking a Senior Specialist – Global CMC Regulatory to join our dynamic team in Bangalore, Karnataka, India. If you have a passion for Regulatory Affairs, CMC (Chemistry, Manufacturing, and Controls), and a desire to innovate in the pharmaceutical industry, this is the perfect opportunity for you!

About Us

We are a global leader in Healthcare, Life Science, and Electronics, dedicated to enriching lives through innovative solutions. Our team thrives on curiosity, collaboration, and a commitment to making a difference. We value diversity, inclusion, and the unique perspectives each team member brings. Join us in shaping the future of science and technology!

Job Title: Senior Specialist – Global CMC Regulatory

Location: Bangalore, Karnataka, India
Job Type: Full-time
Job ID: 285260

Key Responsibilities

As a Senior Specialist – Global CMC Regulatory, you will play a pivotal role in ensuring compliance and driving success in global regulatory submissions. Your responsibilities will include:

1. Project Management & Planning:
   • Execute tasks independently and adhere to agreed timelines.
   • Proactively communicate risks and follow up with cross-functional teams.
   • Maintain strong documentation and project management skills.
2. Regulatory Expertise:
   • Develop and prepare successful CMC regulatory strategies and dossiers.
   • Review and interpret global regulatory guidelines and policies.
   • Ensure high-quality, submission-ready deliverables.
3. Collaboration & Communication:
   • Build relationships with internal and external stakeholders.
   • Act as a role model, mentoring junior staff and improving team communication.
   • Facilitate effective teamwork and resolve conflicts.
4. Systems & Applications:
   • Utilize RA systems (e.g., RIMS/Veeva, EDMS) for routine activities.
   • Ensure compliance with company standards and procedures.
5. Global Exposure:
   • Gain experience in life-cycle management across multiple regions (e.g., Europe, USA, International).
   • Contribute to Pharma business acumen and regulatory strategies.

Who Are We Looking For?

Qualifications:

• Minimum: M.Pharm, MSc, or equivalent degree in Pharmacy, Life Science, Medical, or related discipline.
• Preferred: Higher degree (e.g., PhD in a scientific discipline).

Experience:

• 7+ years of experience in the Pharma industry, Competent Authority, or Academia/R&D.
• 3+ years of hands-on experience in Global CMC Regulatory Affairs.
• Proficiency in MS Office (Word, Excel, PowerPoint, MS Project, Outlook, Skype, SharePoint).
• Advanced skills in RA systems (RIMS/Veeva, EDMS).

Key Skills:

• Experience in Biologics, Biosimilars, or Injectables is a plus.
• Expertise in regulatory dossier preparation and life-cycle management.
• Strong understanding of global pharmaceutical legislation and ICH guidelines.
• Excellent written and spoken English communication skills.

Why Join Us?

• Innovative Environment: Work with cutting-edge science and technology.
• Global Impact: Contribute to projects that improve lives worldwide.
• Diversity & Inclusion: Be part of a team that celebrates all dimensions of diversity.
• Career Growth: Access opportunities for professional development and growth.

What We Offer

• Competitive salary and benefits.
• A culture of inclusion and belonging.
• Opportunities to work on global projects and collaborate with international teams.
• A chance to champion human progress through innovation.

Application Link