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Regulatory Cmc & Devices Lead

8+ years
Not Disclosed
10 Dec. 13, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/PhD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Regulatory CMC and Devices Lead
Location: Hyderabad, India
Job Type: Full-time

About Sanofi

At Sanofi, we are driven by a mission to improve global healthcare by pushing the boundaries of science, innovation, and collaboration. We focus on developing and delivering sustainable health solutions to millions of people worldwide, striving to create a healthier future. Sanofi offers a dynamic and inclusive workplace where people can thrive, grow, and contribute to the transformation of healthcare.

Key Accountabilities

  • Global Regulatory Strategy: Lead the development of global regulatory CMC (Chemistry, Manufacturing, and Controls) strategies for CHC products in re-development and maintenance phases, including chemical and biological entities, herbals, drugs, and devices.
  • Sustainability Roadmap Contribution: Contribute to CHC's Clean Ingredients and Sustainability initiatives by ensuring alignment with global CMC strategies.
  • Regulatory Submissions and Dossiers: Plan and prepare regulatory submissions, including CTAs/INDs, MAAs, international MAs, change amendments, and health authority meetings. Oversee regulatory dossier preparation, review, and publishing processes to ensure timely and high-quality submissions.
  • Cross-Functional Collaboration: Represent GRA CMC CHC in global cross-functional teams, collaborating with leaders from various departments to drive successful product development and lifecycle management.
  • Health Authority Engagement: Lead CMC regulatory content for Health Authority meetings and strategic negotiations, ensuring successful and pragmatic outcomes.
  • Regulatory Intelligence and Risk Management: Contribute to regulatory intelligence efforts and keep up to date with local and global CMC regulations. Identify and mitigate risks associated with CMC activities.
  • CMC Training and Mentorship: Mentor and guide junior staff and team members, sharing knowledge and expertise in regulatory CMC processes and strategy development.

Skills, Experience & Knowledge Requirements

  • Education: Master’s degree in a science/health field (e.g., Pharmacy, Analytical Chemistry, Biological/Biotechnology Sciences) or equivalent; Advanced degree (Master, PhD) preferred.
  • Experience:
    • Minimum of 8 years of relevant experience in regulatory CMC.
    • Global regulatory CMC experience is required; additional experience in pharmaceutical CMC (laboratory, development, manufacturing) is preferred.
    • Demonstrated experience in developing regulatory CMC strategies for medicinal products.
    • Knowledge of CMC requirements for probiotics, food supplements, and medical devices is an advantage.
    • Experience with regulatory health authorities is a plus.
  • Technical Skills:
    • In-depth knowledge of global CMC regulations and guidelines.
    • Proficiency in using digital tools like Veeva Vault RIM, MS Word, Excel, PowerPoint, SharePoint.
  • Personal Characteristics:
    • Strong strategic thinking and ability to work independently.
    • Excellent interpersonal and communication skills, both oral and written.
    • Strong team player with the ability to work in a matrix structure.
    • Self-motivated, entrepreneurial, and solutions-oriented with a "can-do" attitude.
    • “Think outside the box” mindset.

Why Sanofi?

At Sanofi, we offer a culture that encourages growth, collaboration, and innovation. As a part of our team, you will contribute to impactful work, surrounded by a diverse and inclusive group of professionals. We are committed to providing equal opportunities to all individuals and supporting their development in an environment where everyone can thrive.

Equal Opportunity Employer

Sanofi is committed to diversity and inclusion. We provide equal opportunities to all individuals regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Pursue progress. Discover extraordinary.
Join Sanofi in shaping the future of healthcare and be part of a global team working toward meaningful change.