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 successfulย CMC regulatory strategiesย and dossiers.
- Review and interpretย global regulatory guidelinesย 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:
- Utilizeย RA systemsย (e.g., RIMS/Veeva, EDMS) for routine activities.
- Ensure compliance with company standards and procedures.
- Global Exposure:
- Gain experience inย life-cycle managementย across multiple regions (e.g., Europe, USA, International).
- Contribute toย Pharma business acumenย and regulatory strategies.
Who Are We Looking For?
Qualifications:
- Minimum:ย M.Pharm, MSc, or equivalent degree inย Pharmacy, Life Science, Medical, or related discipline.
- Preferred:ย Higher degree (e.g., PhD in a scientific discipline).
Experience:
- 7+ yearsย of experience in theย Pharma industry,ย Competent Authority, orย Academia/R&D.
- 3+ yearsย of hands-on experience inย Global CMC Regulatory Affairs.
- Proficiency inย MS Officeย (Word, Excel, PowerPoint, MS Project, Outlook, Skype, SharePoint).
- Advanced skills inย RA systemsย (RIMS/Veeva, EDMS).
Key Skills:
- Experience inย Biologics, Biosimilars, or Injectablesย is a plus.
- Expertise inย regulatory dossier preparationย andย life-cycle management.
- Strong understanding ofย global pharmaceutical legislationย andย ICH guidelines.
- Excellentย written and spoken Englishย communication skills.
Why Join Us?
- Innovative Environment:ย Work with cutting-edge science and technology.
- Global Impact:ย Contribute to projects that improve lives worldwide.
- Diversity & Inclusion:ย Be part of a team that celebrates all dimensions of diversity.
- Career Growth:ย Access opportunities for professional development and growth.
What We Offer
- Competitive salary and benefits.
- A culture ofย inclusion and belonging.
- Opportunities toย work on global projectsย and collaborate with international teams.
- A chance toย champion human progressย through innovation.