Director - Global Regulatory Lead

vor 1 Woche

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 are driven by the exciting and unique goal of addressing unmet patient and consumer needs by revitalizing, repurposing, and reimagining existing therapies to better serve people in taking care of their health and wellbeing. We focus on the development of a proprietary pipeline of wellness and healthcare products, with a specific focus on highly differentiated products that address unmet medical and consumer needs.

By leveraging our unique and enabling R&D capabilities, we are building a pipeline that includes inhalable medicines and consumer wellness products.


About the Role

This is a great opportunity to apply your regulatory affairs experience in a full development role, and add value to your career. As Director – Global Regulatory Lead (GRL), you will be accountable for the global regulatory strategy for assigned product(s).

Core Responsibilities:
  • Developing regulatory strategies and plans, aimed at achieving regulatory approval and/or optimizing product labeling.
  • Leading the preparation of regulatory documentation such as pre-submission and submission documentation (briefing documents, IND dossiers, CTAs, etc).
  • Leading the correspondence with regulators, meeting requests, and other regulatory interactions.
  • Coordinating the preparation of responses to questions/information requests from US and ex-US regulatory agencies.
  • Assessing and communicating regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines.
  • Providing regulatory guidance and strategic advice to cross-functional teams regarding important development issues.
  • Monitoring, analyzing, and anticipating changes in the regulatory environment, including their impact on ongoing development programs.
  • Management of outsourced regulatory activities.
  • May act as deputy to the Head of Regulatory Affairs in assigned forums or projects.

Role Requirements:
  • Advanced scientific degree and significant experience in regulatory affairs.
  • Excellent communication skills, with the ability to break down complex scientific issues and communicate regulatory implications.
  • Proven success in negotiating regulatory objectives with health authorities.
  • Strong working knowledge of FDA, EMA, and other international and national regulations.
  • Hands-on experience of writing and reviewing regulatory documentation and submissions.
  • Ability to be creative and innovative when solving problems while considering commercial impact.
  • Experience from inhalation drug development is a plus.
  • Experience from drug development in the neurology therapeutic area is a plus.
  • Experience with botanical drug development is a plus.
  • Exceptional interpersonal skills and ability to work across different cultures.

Why Join Us?

We are bound by our shared passion for making a positive impact on the lives of patients and consumers. Vectura Fertin Pharma is a place where you can help shape the future of healthcare, where we collaborate, support, and inspire each other to achieve the best outcomes.

As a growing business, we can offer a wealth of opportunity to develop your career both locally and in international settings. We embrace hybrid and flexible working and are centered on delivering a ‘purpose-driven’ experience for all our employees.

Be part of an inclusive, diverse culture, where everyone’s contribution is respected; collaborate with some of the world’s best people and feel like you belong.

Location

Basel, Switzerland

Messeplatz 10
CH-4058
Basel
Switzerland

#J-18808-Ljbffr

  • Director - Global Regulatory Lead

    vor 2 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...

  • Director, Global Regulatory Affairs

    vor 5 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 5 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 Regulatory Affairs

    vor 5 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 Director

    vor 5 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 Regulatory Affairs Biosimilars

    vor 5 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...

  • Regulatory Affairs Director

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Ironwood Pharmaceuticals Vollzeit

    Job 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,...

  • Sr. Director of Regulatory Compliance

    vor 5 Monaten

    Basel, Schweiz Moderna Vollzeit

    **The Role**: The Sr. Director of Regulatory Process and Compliance position will work cross-functionally to drive activities that will ensure a state of continuous compliance at Moderna and build inspection-preparedness capabilities and sustain a positive compliance reputation between Moderna’s business partners, Health Authorities and cross-functionally...

  • Regulatory Affairs Director

    vor 1 Monat

    Basel, Basel-Stadt, Schweiz Ironwood Pharmaceuticals Vollzeit

    Job SummaryWe are seeking a highly experienced and skilled Regulatory Affairs professional to lead our international regulatory strategy and team. The ideal candidate will have a strong background in pharmaceutical regulatory affairs, with a focus on global drug development and EU regulatory compliance.Key ResponsibilitiesDevelop and implement global...

  • Associate Director, Global Regulatory Science

    vor 5 Monaten

    Basel, Schweiz Moderna Vollzeit

    **The Role**: Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners...

  • Director, Regional Regulatory Strategy, Infectious

    vor 6 Monaten

    Basel, Schweiz Moderna Vollzeit

    **The Role**: Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners...

  • Regulatory Affairs Director

    vor 3 Wochen

    Basel, Basel-Stadt, Schweiz Ironwood Pharmaceuticals Vollzeit

    Key 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...

  • Associate Director, Regulatory Affairs

    vor 6 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. -...

  • Global Quality Assurance Lead

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz BeiGene Vollzeit

    BeiGene is committed to delivering high-quality outcomes through our R&D operations. As an Associate Director, R&D Quality Systems, Strategy, and Excellence, you will play a pivotal role in ensuring global quality policies, procedures, and standards are consistently applied at local affiliate and regional levels.Key responsibilities include:Ensuring global...

  • Clinical Trial Regulatory Lead

    vor 1 Monat

    Basel, Basel-Stadt, Schweiz Roche Vollzeit

    The RoleClinical Trial Regulatory LeadAt Roche, we are committed to developing and maintaining the highest standards of regulatory excellence. As a Clinical Trial Regulatory Lead, you will play a critical role in shaping the regulatory strategy for our clinical trials, ensuring compliance with global regulations and guidelines.Your Key...

  • Lead Medical Director

    vor 3 Wochen

    Basel, Basel-Stadt, Schweiz Roche Vollzeit

    Job Title: Lead Medical DirectorJob Summary: We are seeking a highly skilled Lead Medical Director to lead our Clinical Development organization in the Neuromuscular therapeutic area.About the Role: The Lead Medical Director will be responsible for developing and executing clinical strategies and plans to deliver medically-differentiated therapies that...

  • Associate Director, Global Labeling Strategy Lead

    vor 6 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. **Role & Function** This...

  • Clinical Trials Regulatory Lead

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Roche Vollzeit

    The RoleClinical Trial Regulatory LeadAt Roche, we are committed to developing life-improving therapies worldwide. As a Clinical Trial Regulatory Lead, you will play a crucial role in shaping our regulatory strategy and submissions globally (excluding US, China, and Japan) for molecules and medical devices.You will work closely with early research and...

  • Clinical Trial Regulatory Lead

    vor 6 Monaten

    Basel, Schweiz Roche Vollzeit

    The Position Clinical Trial Regulatory Lead  The Pharma Development Regulatory (PDR) organization develops and maintains the licensees that permit Roche to market and sell its life improving therapies worldwide. We are the stewards of the safety and efficacy of medicines, collaborating with regulators of every country in which Roche does business...

  • Director, Regional Regulatory Strategy, Infectious

    vor 5 Monaten

    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,...