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:
- 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.
- 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.
- 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.
- Systems & Applications:
- Utilize RA systems (e.g., RIMS/Veeva, EDMS) for routine activities.
- Ensure compliance with company standards and procedures.
- 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.
