Regulatory Affairs CMC Team Lead - Cell and Gene Therapy job in East Hanover
|Employer:|| Novartis Pharmaceuticals|
|Category:||Research and Development|
|Job Type:||Full Time|
|State:||New Jersey (NJ)|
Lead a team of associates to support departmental strategies and objectives according to agreed timelines, standards and business priorities for an assigned portfolio of cell and gene therapy projects.. Accountable for leading the strategic direction of the team to support global clinical trial activities, lead to global product approvals, ensure compliant dossiers throughout the product lifecycle, and meeting the targets for projects/products within the group to support the overall franchise. Works in close collaboration with the RA Global Franchise Head as a member of the franchise management team. Project responsibility expected for one or more projects and represents RA CMC on project teams.|
1. As a member of the franchise unit's management team, contribute to the strategy of the franchise unit and the department. 2. Implement global departmental strategic plan and objectives within the team. 3. Ensure robust regulatory strategies are developed and implemented to support global clinical trial activity, global registrations and product approvals, and regulatory compli-ance throughout the product lifecycle. Ensure successful Health Authority interactions on CMC topics. Direct contact with US FDA. 4. Drive consistency and high quality output to ensure global regulatory dossiers are prepared and compliant with global Health Authority regulations and guidances. Make quality regulatory decisions. 5. Monitor regulatory trends and ensure continuous improvement related to HA regulations, guidelines and feedback. Ensure communication and support implementation within and outside the team. 6. Coach and develop people and teams, recruit and reward to retain talent. Support a culture of high performance and trust, assure that the required level of knowledge and skills is available and identify competency gaps. Establish and implement effective training and development plans. 7. Contact person for assigned portfolio, receive requests for RA CMC team and resources, establish and maintain sound working relationships with partners and customers, deputize franchise unit head as necessary at decision-making boards. 8. Ensure and facilitate communication among management, peers and associates; proactively communicate critical situations in an adequate and timely manner to interdisciplinary teams and to appropriate management level in RA CMC, RA, TechOps and TRD as appropriate. 9. Support associates to ensure consistency and quality are maintained and lessons learned and trends are communicated within and outside the department; reinforce consistent use of Regulatory CMC Best Practices, guidelines and HA regulations to ensure the preparation of high quality CMC documentation. Ensure the optimal use of fora for discussion and achieving management agreement on project strategies, appropriate to phase and life cycle. 10. Contribute senior level operational and strategic regulatory input into BD&L and oversee Due Diligence evaluations of assigned BD&L projects 11. Represent Novartis and Global CMC function at international congresses and provide input into emerging guidelines from all regions in order to shape the regulatory environment.Minimum:
Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
Advanced Degree in Sciences (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent discipline.
Fluent English required (oral and written). Good skills in site (local) language desired (oral)
1. 8 years in experience in biopharmaceuticals and/or cell and gene therapy, at least 6 years regulatory preferred.
2. Excellence in influencing people, negotiation and communication skills as well as potential for excellence in leadership.
3. Potential/ability to coach and develop people and teams and to recruit to support the talent pipeline.
4. Excellent working knowledge/experience in regulatory submission and approval processes and proven practical knowledge of and ability to resolve complex CMC regulatory issues and requirements.
5. Proven track record of successfully leading teams, and of planning, coordinating and leading activities simultaneously on multiple projects in multicultural environment.
6. Regularly demonstrated active contributions to line functions or project teams
7. Respected CMC leader within department and/or other line functions.
8. Demonstrated leadership in risk assessment and mitigation, strategic thinking, maintaining awareness of business impact.
9. Demonstrated ability for innovative and big picture thinking.
10. Strong interpersonal, organizational, communication, presentation, negotiation and problem solving skills.
11. Computer literacy (e.g. MS-project, Power Point, document management systems) available and shown ability to quickly learn new software and tracking tools and associated processes.