Associate Director Regulatory Affairs Small

vor 7 Monaten

Basel, Schweiz Lonza Vollzeit

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

We are looking for an Associate Director, Regulatory Affairs Small Molecules (f/m/d) to provide regulatory & strategic guidance (Regulatory Plans) to internal and external customers for our Small Molecules business with Manufacturing sites in Bend (US), Tampa (US), Visp (CH), Monteggio (CH) and Nansha (CN).

Key responsibilities:
- Partner with internal and external stakeholder for preparation (write and/or review ) of high-quality CMC submissions that satisfy the critical regulatory criteria set by FDA, EMA, and/or other significant regulatory bodies, while also aligning with corporate objectives and relevant legislation.-
- Review and evaluate the regulatory impact of the change requests for the Small Molecule Drug Substances and Drug Products manufacturing process incl. technology transfer.- Submit country-specific health authority supporting documents such as Drug Master Files (DMFs), Site Master Files (SMF) or other records on behalf of customers- Utilize prior analytical (Quality Control, Analytical Development) and/or manufacturing process (Operation) or Quality Assurance or Program Management experience to question and propose alternative solutions to challenges by internal and external customers- A solution and service minded proactive approach should be applied even with challenging customers

Key requirements:
- Degree in chemistry, biology, biochemistry, pharmacy or equivalent- Extensive experience in the pharmaceutical and biotechnology industries, specializing in small and midsize molecules, with additional understanding of large molecules being advantageous- Experience in leading small groups and complex programs (team or matrix)- Experience in leading programs on behalf of internal or external stakeholders- Exceptional communication and writing skills, fluency in English and German

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

  • Regulatory Affairs Associate Director, Digestive

    vor 7 Monaten

    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...

  • Associate Director Regulatory Affairs Biosimilars

    vor 6 Monaten

    Basel, Schweiz Abbott Laboratories Vollzeit

    **Abbott **is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160...

  • Associate Director Regulatory Affairs Biosimilars

    vor 1 Monat

    Basel, Schweiz Abbott Laboratories Vollzeit

    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.Abbott...

  • Associate Director Regulatory Affairs Biosimilars

    vor 1 Monat

    Basel, Schweiz Abbott Vollzeit

    JOB DESCRIPTION:Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160...

  • Associate Director Regulatory Affairs Biosimilars

    vor 1 Woche

    Basel, Schweiz Abbott Laboratories Vollzeit

    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.Abbott...

  • 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...

  • Associate Director, Regulatory Affairs

    vor 7 Monaten

    Basel, Schweiz VECTURA FERTIN PHARMA Vollzeit

    Contract Type: Permanent Closing date: Reference: VN1710 - 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 systems. -...

  • Director Regulatory Affairs

    vor 7 Monaten

    Basel, Schweiz BeiGene Vollzeit

    General Description: The Director Regulatory Affairs will be responsible for developing and implementing regulatory strategies for the designated program to secure and maintain marketing authorization in line with business objectives, and in coordination with key internal stakeholders. Essential Functions of the job: - Act as the representative of European...

  • Global Regulatory Affairs Associate, Fast Growing

    vor 7 Monaten

    Basel, Schweiz Stratpharma Vollzeit

    Stratpharma, a fast-growing Dermatology company, is currently looking for a Global Regulatory Affairs Associate to join their dynamic team. This is an exciting opportunity to be part of a company that is experiencing rapid growth and expanding globally. This is a highly successful company who have an impressive 200% year on year growth and are going through...

  • Associate Director Global Scientific Affairs

    vor 7 Monaten

    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.** **Associate Director...

  • Associate Director Global Scientific Affairs

    Vor 4 Tagen

    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.** **Associate Director...

  • Director Regulatory Affairs Cmc and Operations

    Vor 3 Tagen

    Basel, Schweiz Abbott Laboratories Vollzeit

    Abbott Established Pharmaceuticals EPD is looking for a **Director Regulatory Affairs CMC & Operations***:To be based in our Divisional Headquarter in Basel-Allschwil, Switzerland **Primary Job Function**: - Provide strategic global regulatory guidance and leadership on CMC related matters for pipeline development products and on-market products for a...

  • Associate Director Global Scientific Affairs

    vor 2 Wochen

    Basel, Schweiz Cabinet de recrutement Sparkk Vollzeit

    We are looking for an Associate **Director Global Scientific Affairs** for one of our clients, an international pharmaceutical company active in the fields of hematology and immunology. **Responsibilities**: - Develop and lead the scientific communications strategy - Lead the global publication plan in alignment with global medical and scientific affairs...

  • Regulatory Affairs Project Manager

    vor 3 Monaten

    Basel, Schweiz Alira Health Vollzeit

    Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. Job Description...

  • 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...

  • Associate Director or Director Pharmacometrics

    Vor 4 Tagen

    Basel, Schweiz Hengrui USA Vollzeit

    **Reports to (Title): Head of Pharmacometrics** **Location: Basel Switzerland** **Direct Reports : No** **Department: Clinical Pharmacology & Early Development** **Job Summary**: **Essential Job Functions**: - Proficiency in PK, PK/PD, and model-informed drug development (MIDD) principles and analyses. - Serves as a modeling and simulation (M&S)...

  • Manager, Regulatory Affairs, International

    vor 2 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.** **Manager, Regulatory...

  • Associate Director or Director of Pharmacometrics

    vor 2 Wochen

    Basel, Schweiz Hengrui Europe Therapeutics AG Vollzeit

    **Job Title**: Associate Director or Director of Pharmacometrics **Reports to (Title)**: Head of Pharmacometrics **Location**: Basel Switzerland **Direct Reports**: No **Department**: Clinical Pharmacology & Early Development **About Hengrui**: The Hengrui ex-China organization drives the development and commercialization of the Hengrui innovative...

  • REGULATORY AFFAIRS PROJECT MANAGER

    Vor 2 Tagen

    Basel, Schweiz Alira Health Vollzeit

    Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. Job Description...