High Salary: Strategic CMC Specialist

7 days ago

Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 19,99,999 - ₹ 25,99,999
Job Title: Regulatory CMC Lead

A skilled and experienced professional is sought to oversee the strategic development and implementation of CMC regulatory activities for global products.

Key Responsibilities:
  • Represent a company in cross-functional teams and meetings, partnering with leaders to facilitate successful product development and lifecycle management.
  • Develop global regulatory CMC strategies for re-development phase products, including healthcare entities, chemicals, biologicals, herbals, drugs, devices, and maintenance CMC regulatory contributions.
  • Plan submissions and CMC dossier package strategies according to global CMC regulatory strategy for various documents, such as CTA, INDs, MAAs, international MAs, HA meetings, maintenance submissions, change amendments, supplements, commitments, etc.
  • Provide accurate and timely regulatory CMC assessments and expertise input to teams, making recommendations.
Requirements:
  • Masters degree in science or health field, e.g., Pharmacy, Analytical Chemistry, Biological or Biotechnology Sciences, or equivalent.
  • Minimum 2-3 years of global Regulatory CMC experience, with additional technical pharmaceutical CMC experience preferred.
  • Demonstrated experience in developing regulatory CMC strategies for medicinal products, with knowledge and/or experience of CMC requirements for Probiotics, Food Supplements, and Medical Devices an advantage.

Strong interpersonal skills, autonomy, and a can-do attitude are essential qualities for this role. A high level of professionalism and strategic thinking will be valuable assets to our organization.

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