Regulatory Affairs CMC Manager
vor 4 Wochen
Job Description Summary
Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people’s lives.
To do this, we are optimizing and strengthening our processes and ways of working. We are investing in new technologies and building specific therapeutic area and platform depth and capabilities – all to bring our medicines to patients even faster.
We are seeking key talent, like you, to join us and help give people with disease and their families a brighter future to look forward to.
Apply today and welcome to where we thrive together
Job Description
This role offers hybrid working, requiring 3 days per week in our Basel office.
Key Responsibilities:
- Formulate and lead global CMC regulatory strategy with a focus on innovation, maximizing the business benefit balanced with regulatory risks and 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 timeliness 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 submissions, establishing and applying 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.
Essential Requirements:
- Bachelors degree in science (e.g. Chemistry, Pharmacy, Biochemistry, Molecular Biology, Biotechnology, Biology) or equivalent; advanced degree desired.
- Regulatory CMC experience and/or pharmaceutical industry experience; working knowledge of regulatory submissions desirable.
- Demonstrated knowledge/experience in regulatory submission and approval processes and ability to deal with complex CMC regulatory issues and requirements.
- Demonstrated working knowledge of chemistry/ biotechnology, analytics or pharmaceutical technology. Knowledge / experience of regulations, guidelines and product life cycle maintenance desirable.
- Track record of successfully working in a complex cross functional environment and global teams; leading, planning and prioritizing activities simultaneously on multiple projects.
- Proven ability to critically evaluate data from a broad range of scientific disciplines. Strong planning, negotiation, organizational and interpersonal skills.
- Fluency in English, both written and spoken.
Why Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us
Commitment to Diversity & Inclusion: 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 diversity.inclusion_ch@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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