Global Regulatory Strategist

vor 10 Stunden

Basel, Schweiz Bayer Vollzeit

**At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.**

**Global Regulatory Strategist**

**YOUR TASKS AND RESPONSIBILITIES**

This role requires a Global Regulatory Expert who can lead Combination Product Asset Development projects to achieve global registration. The position will work within a team of Global Regulatory Strategists who have regional/local responsibility for their assigned programs. As the Global Regulatory Strategist for Combination Products, this position will provide relevant scientific and technical expertise to development programs that have high impact on Bayer s portfolio, for drug device combinations, cell and gene therapies, and digital assets. Integrating the local/regional regulatory requirements into the best and single global regulatory strategy requires broad global experience and efficient interaction with many multinational and multifunctional partners. The best global regulatory strategy is important in achieving early approvals with competitive labeling. The assessment of the probability of regulatory success has a major impact on the overall Probability of Technical Success (PTS) for a development project and thereby on the prioritization and commercial value of the project.
- Work to develop and implement global regulatory strategies for Combination Products in Bayer s portfolio that leverage regulations in the US, EU and other target markets, and employ innovative approaches that enable fastest path to first cycle approval (e.g., core dossiers, IND, CTA, BLA, MAA, Technical Files, etc.).
- Collaborate with Global Regulatory Strategists on assigned programs that have regional and/or local responsibility to ensure integration of regional/local requirements into the overall Global Regulatory Strategy.
- Participate on key new product development Regulatory Affairs Teams and/or Global Project Teams; effectively collaborate with Bayer s functions involved in combination product development to advance the assigned programs.
- Serve as the Global Regulatory Expert for the assigned programs and partner effectively with CMC, Integrated Care, Medical Devices & eHealth, and Therapeutic Areas, to develop strategy documents to support decision making at Governance committees and for formal meetings with Health Authorities.
- Understand and communicate scientific principles and regulatory requirements relevant to global drug device combination product development.
- Provide global regulatory assessments for requirements of drug device combination products according to existing global guidelines and policies.
- Clearly communicate recommended combination product strategies and changing regulatory requirements, including necessary adaptions to peers, management, and cross functional teams.
- Lead preparations and follow up for project meetings and teleconferences with US/Can/EU health authority officials and aid in other country health authority meeting processes.

**WHO YOU ARE**
- Advanced scientific degree (e.g., PhD) in Biomedical Engineering, Pharmacology, Healthcare, or related discipline preferred, with moderate experience with local/global regulatory submissions for combination products
- MS degree in Biomedical Engineering, Pharmacology, Healthcare, or related discipline with several years of experience with local/global regulatory submissions for combination products.
- BS degree in Biomedical Engineering, Pharmacology, Healthcare, or related discipline with extensive of experience with local/global regulatory submissions for combination products.
- Knowledge of regional and global medical device regulations (e.g., EU MDR, Declarations of Conformity, CE Marking, ISO 13485, FDA Quality System Regulations, Design Control, etc.), particularly as they pertain to development of combination products; demonstrated interactions with local and global health authorities and notified bodies.
- Direct experience in developing regulatory strategies, creation of regulatory submission files obtaining FDA or EU clearance/approvals for combination products is required.
- Experience with regulatory activities for cell and gene therapies or digital technologies (wearable devices, etc.) is preferred.
- Strong ability to communicate and negotiate effectively in English both verbally and in writing, and strong analytical skills are required.
- Demonstrated leadership and project management skills, including cross functional communication, interpersonal and influen

  • Global Regulatory Strategist

    vor 2 Wochen

    Basel, Schweiz Bayer Vollzeit

    **At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...

  • Director, Regional Regulatory Strategist

    vor 3 Wochen

    Basel, Schweiz Moderna Therapeutics Vollzeit

    **The Role**: The Director, Regional Regulatory Strategist - ID will have the opportunity to lead the regulatory strategy with the European Medicines Agency (EMA), act as the regulatory strategy partner for International countries, and provide regulatory support to the VP, Regulatory Affairs - International. This is a new role intended for a forward-looking,...

  • Director, Regional Regulatory Strategist- Id

    Vor 7 Tagen

    Basel, Schweiz Moderna Vollzeit

    **The Role**: The Director, Regional Regulatory Strategist - ID will have the opportunity to lead the regulatory strategy with the European Medicines Agency (EMA) and provide regulatory support to the VP, Regulatory Affairs - International. This is a new role intended for a forward-looking, creative, and agile regulatory Director able to anticipate and...

  • Global Pricing Strategist

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz BeiGene Vollzeit

    Job Summary:BeiGene is seeking an experienced Global Pricing Strategist to lead the development and execution of global pricing strategies, ensuring alignment with the company's commercial and market access goals.About BeiGene:Beyond our passion for fighting cancer, we are a team of dedicated professionals who thrive in an environment that encourages...

  • Global Program Regulatory Director

    vor 2 Wochen

    Basel, Schweiz Sandoz Vollzeit

    1996! In this year Sandoz initiated the world’s first biosimilar development program. Over 20 years of experience in biosimilar development have equipped us with extensive knowledge and outstanding expertise in the development, manufacturing and commercialization of biosimilar medicines to the healthcare community and patients worldwide. - Global Drug...

  • Liaison Global Regulatory Strategy Integration

    vor 2 Wochen

    Basel, Schweiz Bayer Vollzeit

    **At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...

  • Global Pricing Strategist and Operational Leader

    vor 4 Wochen

    Basel, Basel-Stadt, Schweiz BeiGene Vollzeit

    BeiGene is a rapidly growing pharmaceutical company seeking an experienced Global Pricing Strategist and Operational Leader to join our team. This role offers a competitive salary of $150,000 - $200,000 per year, depending on location and experience.About the RoleWe are looking for a highly motivated and collaborative individual who shares our passion for...

  • Head of Global Regulatory Strategy, Immunology

    vor 3 Wochen

    Basel, Schweiz Sobi Vollzeit

    **Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.** **Head of Global...

  • Global Regulatory Submission Publisher

    Vor 3 Tagen

    Basel, Schweiz Warman O'Brien Vollzeit

    A Global Regulatory Submissions Publisher is required for a long-term contract with a global pharma based in Basel. **Major Accountabilities**: - Responsible for electronically preparing, publishing, quality reviews, validation (using eCTD validator tool) and dispatch activities related to regulatory submissions (i.e., INDs, BLAs/NDAs, MAAs, HA A to Qs,...

  • Regulatory Affairs Manager 100%

    vor 11 Stunden

    Basel, Schweiz Global Personal Partner Vollzeit

    **EINFÜHRUNG**: Our profession and our passion are "HR Management". Global Personal is an independent company of the Interiman Group SA with over 100 employees offering a complete range of services in the field of Human Resources at 21 locations in German-speaking Switzerland. For our client, an international technology company in Basel, we are looking...

  • Director, Global Regulatory Affairs

    vor 7 Monaten

    Basel, Schweiz Ironwood Pharmaceuticals Vollzeit

    VectivBio is a global, clinical-stage biotechnology company focused on the discovery, development, and commercialization of innovative treatments for severe rare conditions with high unmet medical need. VectivBio is now a part of Ironwood Pharmaceuticals, Inc., a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of...

  • Director, Global Regulatory Affairs

    vor 7 Monaten

    Basel, Schweiz Ironwood Pharmaceuticals Vollzeit

    VectivBio is a global, clinical-stage biotechnology company focused on the discovery, development, and commercialization of innovative treatments for severe rare conditions with high unmet medical need. VectivBio is now a part of Ironwood Pharmaceuticals, Inc., a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of...

  • Manager, Regional Regulatory Strategy- Oncology

    vor 3 Wochen

    Basel, Schweiz Moderna Therapeutics Vollzeit

    **The Role**: The Manager of Regulatory Strategy-International based in Basel, Switzerland will have the opportunity to provide regulatory support to the Director, Regulatory Affairs-Regional Regulatory Strategist, - EU & International. This is a newly created role intended for a forward looking, creative and agile regulatory manager able to anticipate and...

  • Global Program Regulatory Manager

    vor 7 Monaten

    Basel, Schweiz Novartis Vollzeit

    394918BR **Global Program Regulatory Manager (GPRM - Cardiometabolic)**: Switzerland **About the role** 26 major approvals, 13 major submissions and 2,000 associates worldwide. That was Regulatory Affairs in 2020. We are a culturally diverse, global team of talented professionals seeking to leverage the voices of our patients in our approach to bringing...

  • Director - Global Regulatory Lead

    vor 4 Monaten

    Basel, Schweiz VECTURA FERTIN PHARMA Vollzeit

    Contract Type: Permanent Closing date: Reference: VN1863 - About us Who we are Vectura Fertin Pharma’s ambition is to become a market-leading wellness and healthcare business. Formed in March 2022, the business brings together two unique organizations: Vectura, experts in inhalation technology and Fertin Pharma, experts in oral and intra-oral delivery...

  • Global Program Regulatory Manager

    vor 1 Woche

    Basel, Schweiz Novartis Vollzeit

    1,800+ associates. 86 countries. One Regulatory Affairs. At Novartis your voice, experience, and quality mindset can truly make a difference in Regulatory Affairs (RA). Novartis has a unique and promising portfolio with 70 projects as potential NMEs in development, 65 projects in Phase 3 or already undergoing registration, and 100 Phase 1/2 projects. We also...

  • Director - Global Regulatory Lead

    vor 2 Monaten

    Basel, Schweiz VECTURA FERTIN PHARMA Vollzeit

    Contract Type: Permanent Closing date: Reference: VN1863 About Us Vectura Fertin Pharma’s ambition is to become a market-leading wellness and healthcare business. Formed in March 2022, the business brings together two unique organizations: Vectura, experts in inhalation technology and Fertin Pharma, experts in oral and intra-oral delivery systems. We...

  • Global Regulatory Cmc Lead

    vor 1 Tag

    Basel, Schweiz Hobson Prior Vollzeit

    Hobson Prior are collaborating with a brilliant pharma establishment who are currently looking for an individual to join their team on a permanent basis located in either Basel or Stockholm. Our client is focused on offering novel remedies that will transform the lives of those suffering from rare illnesses. Th opening position is for a Global regulatory CMC...

  • Quality & Regulatory Associate, Challenging Global

    vor 7 Monaten

    Basel, Schweiz Stratpharma Vollzeit

    An ambitious forward thinking Dermatology company based in the centre of Basel have created an exciting hybrid QARA Associate opportunity that will work closely with the International QARA Director in managing the company’s global QA and RA functions. This is a highly successful company who have an impressive 200% year on year growth and are going through...

  • Global Regulatory Affairs Director

    vor 7 Monaten

    Basel, Schweiz Coopers Group AG Vollzeit

    Global Regulatory Affairs Director We are looking for a person who will develop/lead/implement regulatory strategy through a global regulatory team approach for assigned projects or product(s) across all phases of product development, and ensure timely development of regulatory strategy and operating plans. **Responsibilities** - Participate in or lead...