Regulatory CMC Manager

Job description

Job Description

•Lead global CMC regulatory activites for development projects or marketed products with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance
•Proactively communicate CMC regulatory strategy, key issues and any other critical topics throughout the life cycle in an adequate and timely manner to in-terdisciplinary project teams and to appropriate management level in Reg CMC, DRA, TechOps and TRD as appropriate.
•Lead and implement all global CMC submission activities (planning, authoring, re-viewing, coordination, submission) for assigned projects/products, while applying the global strategy into submissions. Make quality regulatory decisions, balan-cing risks and benefits.
•As early as possible, identify the required documentation and any content, quali-ty and/or timeliness issues with them for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
•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.
•Establish and maintain sound working relationships with partners and customers.
•Support Health Authority interactions and negotiations as appropriate; setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans.
•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.
•Prepare and communicate CMC dossier risk analyses (SWOTS), contingency plans and Lessons Learned on major submissions with subteams and escalate with management as appropriate.
•Keep knowledge up to date with regard to regulatory guidelines and require-ments in all global regions as well as for new technical trends.
•Assume specialized assignments as assigned and represent Reg CMC in cross functional project teams.
Position Title

Regulatory CMC Manager

Desired profile

Minimum requirements

-Degree in Science (e.g. Pharmacy, Biochemistry, Biomanufacturing, Biotechnology, Biology) or equivalent
-Desirable: Advanced Degree in Science (Pharmacy, Biochemistry, Biotechnology) or equivalent.
-2-4 years in regulatory preferred, and/or experience in drug/biopharmaceuticals development
-Working knowledge of biotechnology, analytics or pharmaceutical technology. Knowledge of the drug development process desirable. Ability to critically evaluate data from a broad range of scientific dis-ciplines.
-Demonstrated track record to successfully work in interdisciplinary teams, planning, coordinating, leading activities simultaneously on multiple projects.
-Knowledge/experience of regulations, guidelines for ATMPs, vac-cines or biologics desirable.
-Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload.
-Effective planning, organizational and interpersonal skills.
-Reasonable approach to risk assessment.
-Excellent written/spoken communication and negotiation skills.
-Computer literacy.
Job Type

Full Time
Country

Switzerland
Work Location

Basel
Division

Global Drug Development
Business Unit

REG AFFAIRS GDD
Employment Type

Temporary
Company/Legal Entity

Novartis Pharma AG