Global Regulatory Affairs Director
vor 7 Monaten
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 departmental and cross-functional task forces and initiatives;
- Demonstrate ability to anticipate risks and responsible for developing solutions to identified risks; understand probabilities of technical success for the solutions;
- Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner;
- Understand and interpret scientific data as it relates to regulatory requirements and strategy for assigned projects and provide knowledge and expertise to guide team in established and building appropriate regulatory strategy;
- Demonstrate solid understanding of current US and EU regulations and guidance, political and legal climate and industry practices to assist in meeting organizational goals.
- Demonstrate increasing independence in the area of regulatory strategy such as understanding broad concepts within Regulatory Affairs and implications across the organization and globally; proactively identify regulatory issues; offer creative solutions and strategies, including risk mitigation strategies;
- Provide strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements;
- Point-lead for interfacing with Health Authority review teams and is a leader that facilitates approval of regulatory submissions and coordinates responses to Health Authorities with appropriate personnel and departments to resolve new or outstanding regulatory issues;
- Represent 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;
- Work with Regulatory Writing, CMC and Operations teams to establish and meet timelines for regulatory submissions;
- Regularly report to management on progress against objectives and plans. Plan and direct projects and provide technical background, inspiration, leadership, and consultation to cross-functional colleagues as well as members of the global regulatory project team;
- Provides regulatory input to patient-centered outcomes research, market access/HTA strategy and submissions;
**Profile**
- Masters degree in a science field such as Biology, Chemistry, or Pharmaceutical sciences
- 10+ years of experience in a pharmaceutical industry in global Regulatory Affairs
- 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 US, EU and international countries.
- An extensive background and excellent relationship in working with the FDA,
- Rare disease and pediatric drug development experience is highly desirable.
- Strong working knowledge regarding selection, development and evaluation of Clinical Outcome Assessments (COAs)
- Regulatory strategic and operational support to implement global Managed Access Programs
- Strong leadership abilities and the communication and interpersonal skills needed to influence decision-making in a diplomatic manner, particularly in relation to regulatory strategies
Sounds like a great job?
-
Director, Global Regulatory Affairs
vor 7 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, Global Regulatory Affairs
vor 7 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 7 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...
-
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...
-
Director Regulatory Affairs Cmc and Operations
Vor 3 Tagen
Basel, Schweiz Abbott Laboratories VollzeitAbbott 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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
Global Regulatory Affairs Associate, Fast Growing
vor 7 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...
-
Global Regulatory Affairs Coordinator
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.** **Global Regulatory...
-
Director - Global Regulatory Lead
vor 2 Monaten
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...
-
Global Regulatory Affairs Manager
vor 2 Wochen
Basel, Schweiz EDP Personalberatung Vollzeit**#Pharma #RegulatoryAffairs***: Our customer, a **pharmaceutical company based near Basel**, needs reinforcement. For a **temporary employment** **, **we are looking for a **Global Regulatory Affairs Manager (M/F/d), 100%**: **Jetzt bewerben** **Major accountabilities**: - Lead the joint efforts for the development of the global product approval...
-
Director - Global Regulatory Lead
vor 4 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...
-
Director, Global Regulatory Labeling
Vor 5 Tagen
Basel, Schweiz Moderna Therapeutics Vollzeit**The Role**: Moderna Therapeutics is seeking a Director of Regulatory Labeling to support new and existing programs to be based in Basel or other International Moderna hub. This is a newly created role intended for a forward looking, creative regulatory professional able to anticipate and address the challenges involved in swiftly delivering labeling for...
-
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...
-
Basel, Schweiz BeiGene VollzeitGeneral Description: Under the direction of the General Manager Sub Region Europe, this individual is responsible for the local representation of regulatory affairs and quality assurance in SRE. The incumbent provides dynamic leadership, strategic direction and close oversight of all regulatory affairs and compliance activities in SRE across BeiGene's...
-
Global Program Regulatory Director
Vor 7 Tagen
Basel, Schweiz Sandoz Vollzeit1996! 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...
-
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...
