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Apply to JobJob ID241813BRPosition TitleRegulatory CMC Senior Manager Cell & GeneJob DescriptionThe Regulatory CMC Senior Manager will independently, provide strategic and operational global CMC regulatory direction and documentation for projects/products within their responsibility, including development, registration and approval/post approval activities as assigned.



Main Activities & Responsibilities:

1. Formulate, lead and drive regional and/or global CMC regulatory strategy for assigned development projects and/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, Drug Regulatory Affairs (DRA), TechOps and Technical Research & Development as appropriate.

3. Lead and implement all regional CMC submission activities (planning, review, coordination, submission) for assigned projects/products, while applying the global strategy into regional submissions.

4. Establish and maintain a single point of contact with FDA or Country Pharma Organisations, DRA Emerging Growth Markets, DRA Latam and DRA Therapeutic Area for all communication on development and marketed products. Establish and maintain sound working relationships with partners and customers.

5. Initiate and lead regional Health Authority interactions and negotiations as appropriate; setting objectives, preparing briefing books, coordinating and planning rehearsals.

6. Lead cross-functional Health Authority Response Teams (HARTs) for assigned development projects and/or marketed products, as appropriate.

7. Lead preparation of CMC dossier risk analyses, contingency plans and Lessons Learned documentation on major submissions for communication and action planning with subteams.

8. Represent Reg CMC, and therefore provide input to licensing decisions, on due diligence and divestment teams.

9. Represent Reg CMC on teams for continuous improvement within the department.

10. Provide leadership within the department and within specialized matrix functions.

11. Act as mentor/coach to new members of Reg CMC; act as coach to all Reg CMC members in areas of expertise.Minimum requirementsEducation:

Minimum: Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent. Desirable: Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent.



Language:

Fluent English required (oral and written). Good skills in site (local) language desired (oral).



Professional Experience:

1. Minimum 4 years in regulatory preferred, and/or experience in drug/biopharmaceuticals

2. 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 track record of successfully 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. Demonstrated ability for strategic thinking, maintaining awareness of business impact.

6. Demonstrated ability for risk assessment and mitigation.

7. Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload.

8. Effective planning, organizational and interpersonal skills.

9. Excellent written/spoken communication, negotiation skills and problem solving skills.

10. Computer literacy.DivisionGlobal Drug DevelopmentBusiness UnitREG AFFAIRS GDDLocationSwitzerlandSiteBaselCompany/Legal EntityNovartis Pharma AGFunctional AreaResearch & DevelopmentJob TypeFull TimeEmployment TypeRegular

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