Global program regulatory director
Novartis pharma gmbh
- Holzkirchen
stellenbeschreibung
Job Description 8! This is the number of high quality biosimilars for which Sandoz has already received a marketing authorization, and that already provided increased access to life-saving medicines to patients worldwide. Additionally we do have a rich pipeline of further biosimilars under development! For this environment we are recruiting a Global Program Regulatory Director (m/f/d) Your responsibilities:Regulatory Strategy:
- Provide regulatory leadership to assigned program(s) - Develop high quality and globally aligned regulatory strategies to achieve efficient development objectives and life cycle management plans - Evaluate and clearly communicate to management regulatory risks/gaps and trade-offs for the overall development plan and develop mitigation/contingency plans for identified risks - Responsible for development and implementation of the Regulatory Functional Plan - Lead interactions with regulatory consultants/advisors for strategic input and challenge - Represent RASB on the GPTs and communicate key program information to regulatory subteam members and RASB management - Provide strategic input to GPT and sub-team on key HA documents, acquiring appropriate line endorsement as appropriate - Provide strategic regulatory input into BD&L Due Diligence evaluations as required HA Interactions:
- Develop global regulatory strategy and plans for Health Authority (HA) interactions as appropriate - Contribute to and review HA responses, as the need arises, to ensure appropriate, consistent and complete answers to any HA questions - May lead interaction with HAs during key HA Meetings Submissions and Approvals:
- Lead the global submission planning process, including potential Advisory Committees - Lead regulatory submission process throughout program lifecycle on behalf of GPT. This includes oversight of submission plan, generation and sign-off of key regulatory/response components Prescribing information:
- Provide input to RASB labeling for developing the Prescribing Information based on PI of local reference product - Responsible for presenting to RASB labeling any product-specific updates affecting the PI Managerial:
- Effective matrix management of regulatory team(s) consisting of Regulatory - Managers and Associates and other RASB line functions, providing, to the extent possible, mentorship and opportunities for growth and development Minimum requirements Requirements:
- Science based BS or MS with requisite experience and proven capability. Advanced degree (MD, PhD, PharmD) preferred - Minimum 6-8 years of regulatory and drug/biologic development experience, ideally spanning activities in Phases I-IV - Proven leadership and accomplishment in all aspects of regulatory affairs in a global/matrix environment in the pharmaceutical industry - Major involvement in a CTD/MAA/BLA submission and approval - Leadership role in HA negotiations in multiple regions - Proven success in global biologic regulatory submissions - Excellent management, interpersonal, communication, negotiation and problem solving skills - Proficiency in English as a business language. Additional language is an asset Why consider Sandoz? Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic
And we Never Stop Asking
:
how can we continue to pioneer access in an ever-more digital and global world? the answers come when curious, and collaborative people are empowered to ask new questions, make results-oriented decisions and take risks. sandoz, a novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics. join us, and help reimagine access to medicine. sandoz stands up for equal opportunities and for the integration of persons with disabilities. hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability. division sandoz business unit biopharma sz location germany site holzkirchen (near munich) company/legal entity hexal ag functional area research & development job type full time employment type regular shift work no
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