Associate Director Reg CMC Hyderabad India
Novartis - Hyderabad, Andhra Pradesh
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1. Formulate, lead and drive global CMC regulatory strategy for development projects or marketed products with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance.
2. Proactively communicate CMC regulatory strategy, key issues and any other critical topics throughout the life cycle in an adequate and timely manner to interdisciplinary project teams and to appropriate management level in Reg CMC, DRA, TechOps and TRD as appropriate.
3. Lead and drive all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products, while applying the global strategy into submissions. Make quality regulatory decisions, balancing risks and benefits.
4. As early as possible, identify the required documentation and any content, quality and/or timeliness issues with them for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
5. Author high-quality CMC documentation for HA submission, applying CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements.
6. Establish and maintain a single point of contact with FDA or CPOs, DRA regional and TA groups for all communication on development and marketed products. Establish and maintain sound working relationships with partners and customers.
7. Initiate and lead Health Authority interactions and negotiations as appropriate; setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans.
8. Lead and drive cross-functional CMC Health Authority Response Teams (HARTs) for assigned development projects and/or marketed products, and prepare CMC responses, as appropriate.
9. Lead, prepare and communicate CMC dossier risk analyses (SWOTS), contingency plans and Lessons Learned on major submissions and escalate to management as appropriate.
10. Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.
11. Represent Reg CMC on due diligence teams for in-licensing and divestment oppor-tunities.
12. Participate on teams for continuous improvement within and outside the department to continuously improve working practices and processes.
13. Provide advice and direction within the department within specialized assignments as assigned and by utilizing CMC regulatory expertise to drive improvements.
14. Act as mentor to new or less experienced members of Reg CMC.
15. Provide training on critical regulatory points of CMC documentation and lessons learned within and outside the department. Minimum requirements Minimum:
Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent.
Fluent English required (oral and written). Good skills in site (local) language desired (oral)
1. 10-15 years in regulatory preferred, and/or experience in drug/biopharmaceuticals
2. Excellent working knowledge/experience in regulatory submission and approval processes for new chemical entities (NCE) and product life cycle management and proven practical knowledge of and ability to deal with complex CMC regulatory issues and requirements.
3. Proven excellence in successfully leading/working in interdisciplinary teams and planning, coordinating and leading activities simultaneously on multiple projects.
4. Regularly demonstrated active contributions to line functions or project teams, as well as ability to contribute to matrix teams with the necessary strategic thinking.
5. Respected CMC expert within department and/or other line functions.
6. Demonstrated leadership in strategic thinking, maintaining awareness of business impact.
7. Demonstrated leadership in risk assessment and mitigation.
8. Demonstrated ability for innovative and big picture thinking.
9. Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload.
10. Strong planning, organizational and interpersonal skills.
11. Excellent written/spoken communication, negotiation skills and problem solving skills.
12. Computer literacy. Novartis - 11 months ago