Director, Global Regulatory Affairs
vor 6 Monaten
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 GI diseases and redefine the standard of care for GI patients. Ironwood Pharmaceuticals is headquartered in Boston, Massachusetts, and has operations in Basel, Switzerland.
**Purpose of this role**:
The Director, GRA will report to the Head of GRA, Apraglutide, and will be responsible for providing company-wide regulatory direction for product development and guidance to develop rapid successful strategies for market approval(s) aligned with business objective(s) and compliance with applicable European, US and international regulations. The Director, GRA will develop and advance organizational policies and procedures, while also anticipating regulatory obstacles and risks/emerging issues that may impact current or future projects while developing the corresponding solutions. The Director will be effective in collaborating within the organization and provide leadership by communicating, executing, and providing guidance to team members toward achieving the department/corporate objectives.
**Organizational Home**:
This role is located in Basel, Switzerland (remote) with occasional travel to Boston, USA.
**Major Accountabilities**:
- 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;
- In close collaboration with the Head of GRA, Apraglutide, leads the design and implementation of core submission team meetings and plans to ensure clear status and adherence to schedule, with timely escalation as required.
- Coordinates, supports and ensures alignment in regard to Partner submissions to ensure clear status of the activities and adherence to the agreed schedule. Ensures timely escalation of issues and concerns with impact assessment and risk mitigation plans as required.
- Demonstrates a solid understanding of current US and EU regulations and guidance, political and legal climate, and industry practices to assist in meeting organizational goals. Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
- Anticipates risks and proactively develops solutions to identified risks; understands probabilities of technical success for the solutions;
- Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide the team in building appropriate regulatory strategy;
- Demonstrates independence in the area of regulatory strategy such as understanding broad concepts within Regulatory Affairs and implications across the organization and globally;
- Represents company at regulatory agencies for assigned products, including planning and conducting meetings, as well as ensuring submitted documents are compliant and of the highest quality;
- Monitors and shares Regulatory Intelligence;
- Works with cross-functional teams and GRA team members to ensure adherence to timelines for regulatory submissions.
- Regularly reports to line management on progress against objectives and plans. Directs project execution against plan and provides technical support, inspiration, leadership, and consultation to cross-functional colleagues as well as members of the global regulatory project team.
- Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgment and communicating in a professional and timely manner;
- Other regulatory affairs duties as assigned or as business needs require.
**Profile (Skills, experiences, and qualifications required for the job)**
- Bachelor’s degree in a science field such as Biology, Chemistry, or Pharmaceutical sciences. Advanced degree preferred, but not required.
- At least 8+ years of Regulatory Affairs experience in small molecule or biologic drug development and registration activities or a combination of 6+ years of Global Regulatory Affairs and related experience.
- Demonstrated recent successful global Regulatory Affairs track record in the development, submission, and registration of new drugs (biologics, innovative medicines, drug/device combination products, etc.) in the EU and internationally. Rare disease and pediatric drug development experience is highly desirable.
- Must have strong communication and interpersonal skills needed to influence internal stakeholders in a diplomatic manner to ensure project success.
- Demonstrate excellent teamwork and communication skills with the ability to impact and influ
-
Director, Global Regulatory Affairs
vor 6 Monaten
Basel, Schweiz Ironwood Pharmaceuticals VollzeitVectivBio 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 Regulatory Affairs
vor 6 Monaten
Basel, Schweiz BeiGene VollzeitGeneral 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 Director
vor 6 Monaten
Basel, Schweiz Coopers Group AG VollzeitGlobal 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...
-
Regulatory Affairs Director
vor 2 Monaten
Basel, Basel-Stadt, Schweiz Ironwood Pharmaceuticals VollzeitKey Responsibilities:As a crucial member of Ironwood Pharmaceuticals' Regulatory Affairs team, you will develop and implement global regulatory strategies for assigned projects and products, ensuring timely development and submission of regulatory materials. Your expertise will help navigate complex regulatory landscapes, drive strategic planning, and foster...
-
Regulatory Affairs Director
vor 1 Monat
Basel, Basel-Stadt, Schweiz Ironwood Pharmaceuticals VollzeitJob Description for Regulatory Affairs Director at Ironwood PharmaceuticalsResponsibilities and Expectations Develop and lead global regulatory strategies for assigned projects or products across all phases of product development, ensuring timely development and implementation. Participate in or lead cross-functional task forces and initiatives,...
-
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 3 Wochen
Basel, Schweiz Abbott Laboratories VollzeitAbbott 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 3 Wochen
Basel, Schweiz Abbott VollzeitJOB 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...
-
Global Regulatory Affairs Leader
vor 4 Wochen
Basel, Basel-Stadt, Schweiz Ironwood Pharmaceuticals VollzeitJob SummaryWe are seeking a highly experienced and skilled Global Regulatory Affairs Leader to join our team at Ironwood Pharmaceuticals. In this role, you will be responsible for developing and implementing regulatory strategies across all phases of product development, ensuring timely development of regulatory strategy and operating plans.
-
Associate Director Regulatory Affairs Biosimilars
vor 4 Wochen
Basel, Schweiz Abbott VollzeitAbbott 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...
-
Global Regulatory Affairs Associate, Fast Growing
vor 6 Monaten
Basel, Schweiz Stratpharma VollzeitStratpharma, 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...
-
Regulatory Affairs Specialist in Global Dermatology
vor 4 Wochen
Basel, Basel-Stadt, Schweiz Stratpharma AG VollzeitStratpharma AG, a rapidly growing dermatology company, is seeking an experienced Regulatory Affairs Associate to join their team. With a strong focus on global expansion and product development, this role offers an exciting opportunity for individuals looking to make a meaningful impact.The ideal candidate will have a solid understanding of regulatory...
-
Director - Global Regulatory Lead
vor 1 Monat
Basel, Schweiz VECTURA FERTIN PHARMA VollzeitContract 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...
-
Director - Global Regulatory Lead
vor 3 Monaten
Basel, Schweiz VECTURA FERTIN PHARMA VollzeitContract 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...
-
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...
-
Regulatory Affairs Director
vor 1 Monat
Basel, Basel-Stadt, Schweiz Lonza VollzeitLonza is a global leader in life sciences, operating across three continents. Our success is built on talented people working together to develop innovative solutions that improve human lives. We empower our employees to own their careers, fostering a work environment that values creativity, diversity, and collaboration.Key ResponsibilitiesAuthor and review...
-
Basel, Basel-Stadt, Schweiz Lonza VollzeitLonza, a global leader in life sciences, seeks a seasoned expert to drive regulatory excellence in our Small Molecules business. This is an exciting opportunity to leverage your expertise and passion for regulatory affairs to make a meaningful impact on the lives of millions.
-
Associate Director, Regulatory Affairs
vor 7 Monaten
Basel, Schweiz VECTURA FERTIN PHARMA VollzeitContract 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. -...
-
Regulatory Affairs Project Manager
vor 2 Monaten
Basel, Schweiz Alira Health VollzeitJoin 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...
-
Basel, Basel-Stadt, Schweiz Stratpharma AG VollzeitStratpharma AG - A Fast-Growing Dermatology CompanyWe are seeking a highly skilled Regulatory Affairs Associate to join our dynamic team in ensuring compliance with regulatory requirements and supporting the global registration and approval process for our products.Key Responsibilities:Manage and maintain product registrations and submissions for global...
