Job title: Regulatory CMC and Devices Lead
• Location Hyderabad
• Job type: Fulltime Key accountabilities:
• Represent GRA CMC CHC in Global cross-functional teams and meetings, partners with the leaders of these teams to facilitate successful product development and life cycle management
• Develop global regulatory CMC strategies for products in re-development phase (within health care products: chemical and biological entities, herbals; drugs, devices) as well as during maintenance.
• CMC regulatory contribution to CHC´s Clean Ingredients´ and Sustainability Roadmap
• Plan submissions and CMC dossier/package strategies according to the product’s global CMC regulatory strategy for 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 cross-functional teams´ recommendations
• Communicate project plans, status and updates to management
• Facilitate together with the CMC teams and regional/local regulatory experts the planning and execution of regulatory actions (submissions, Health Authority (HA) meetings, etc.)
• Coordinate and support dossier preparation, review and publishing process in line with project timelines.
• Ensure high quality global filings with timely approvals.
• Manage regulatory databases for planning and tracking of regulatory submissions.
• Assure that, for major CMC activities with a critical regulatory and/or financial impact, risks are identified, communicated, and mitigated as needed.
• Assure that positive and collaborative relationships are developed with CMC/Manufacturing & Supply teams to achieve successful implementation in accordance with project planning.
• Initiate required Health Authority meetings in collaboration with Country Regulatory Teams, and conduct them in an effective manner, whilst developing positive and favorable relationships. Lead the Regulatory CMC content of HA meetings as Subject Matter Expert. Support strategic negotiations with worldwide Regulatory Health Authorities so that appropriate and pragmatic positions are negotiated with the highest Probability of Success (POS)
• CMC regulatory contribution/review and expert recommendation to the CMC writer within Development Units and Manufacturing & Supply Organisation.
• Due Diligence of regulatory CMC dossiers.
• CMC Regulatory Intelligence: Contribute to Regulatory Science and Policy activities as well as other internal or external policy initiatives related to CMC regulatory topics. Monitor the review of local and international Health Authority regulations and guidelines, contribute to the commenting process and/or develop position papers. Assure that current Health Authority thinking, and trends (paradigm shifts) are understood and broadly communicated.
• As applicable, support of Health Authority inspections for Global CMC Regulatory questions SKILLS, EXPERIENCE & KNOWLEDGE REQUIREMENTS Education:
• Masters in a science/health field (e.g.: Pharmacy, Analytical / Chemistry, Biological/Biotechnology Sciences etc.), or equivalent; Advanced degree (Master, PhD) is preferred Required knowledge and/or experience:
• 8+ years of relevant experience in Regulatory CMC.
• Global Regulatory CMC experience minimum is required. Candidates with additional technical pharmaceutical CMC experience (laboratory, development, manufacturing, etc.) will be preferred.
• Demonstrated experience in developing regulatory CMC strategies for medicinal products
• Knowledge / experience of CMC requirements for Probiotics, Food Supplements and Medical Devices will be great advantage.
• Experience working for a Regulatory Health Authority is helpful but not essential.
• Potential to be able to mentor and train staff is a plus. Other Personal Characteristics:
• Strategic thinker
• Strong interpersonal skills, autonomy
• Ability to work in a highly matrix structure
• Strong team player
• End-to-end thinking, mindfulness of our goals for our consumers, customers and our company
• Excellent oral and written presentation skills
• Dedicated and persuasive “can-do” attitude
• Self-motivated; entrepreneurial spirit
• “Think out of the box” mindset Technical skills:
• Knowledge of global CMC regulations/guidelines
• Proficiency in using Veeva Vault RIM and other digital tools (MS Word, Excel, PowerPoint, Sharepoint), Language skills:
• Fluency in oral and written English language
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
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