Regulatory Affairs CMC Manager (Cell & Gene Therapies)

Basel - Switzerland

Monthly Salary: Not Disclosed

Posted on: 19 days ago

Vacancies: 1 Vacancy

Job Summary

Job Description Summary

#LI-Hybrid (3 days per week on-site)
Location: Basel Switzerland

As a manager in our team youll provide strategic and operational direction for CMC regulatory activities across the product lifecyclefrom development through post-approval. Your deep understanding of drug development manufacturing and analytical testing combined with a collaborative and patient-focused mindset will help shape the future of our innovative therapies.

Job Description

Major accountabilities:

Formulate and lead global CMC regulatory strategy with a focus on innovation balancing business benefit with regulatory compliance.
Lead and implement global CMC submission activities (planning authoring reviewing coordination submission) for assigned projects/products.
Identify the required documentation and any content quality and/or timelines issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
Author and/or review high-quality CMC documentation for HA submission applying agreed CMC global regulatory strategies current regulatory trends and guidelines. Ensure technical congruency and regulatory compliance meeting agreed upon timelines and e-publishing requirements.
Proactively communicate CMC regulatory strategies risks and key issues throughout the life cycle in a timely manner to project teams and other stakeholders. Represent department in cross-functional project teams.
Prepare and communicate CMC risk management assessments and lessons learned on major submissions.
Initiate and lead Health Authority interactions and negotiations.

Minimum requirements:

Science degree (e.g. Chemistry Pharmacy Biochemistry Molecular Biology Biotechnology Biology) or equivalent
At least 2 years experience in regulatory CMC experience and/or pharmaceutical industry experience; working knowledge in regulatory submissions desirable.
Demonstrated working knowledge of chemistry/biotechnology analytics or pharmaceutical technology.
Knowledge/experience of regulations guidelines and product life cycle maintenance.
Ability to critically evaluate data from a broad range of scientific disciplines.

Commitment to Diversity and Inclusion/EEO

Novartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve.

Accessibility and accommodation

Novartis is committed to working with and providing reasonable accommodation to all individuals. If because of a medical condition or disability you need a reasonable accommodation for any part of the recruitment process or in order to receive more detailed information about the essential functions of a position please send an e-mail to and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Skills Desired

Change Control Cross-Functional Teams Documentation Management Negotiation Skills Regulatory Compliance Risk Assessment Risk Management Waterfall Model

Required Experience:

Manager

Job Description Summary#LI-Hybrid (3 days per week on-site)Location: Basel SwitzerlandAs a manager in our team youll provide strategic and operational direction for CMC regulatory activities across the product lifecyclefrom development through post-approval. Your deep understanding of drug developme...