Director - Global Regulatory Lead

vor 3 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 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. What we will deliver 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

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 optimize product labelling.
- 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
- Assess and communicate regulatory requirements to ensure all development activities are in compliance with applicable regulation and guidelines, or with scientific rational and risk-based approach to deviations.
- Provide regulatory guidance and strategic advice to cross-functional teams regarding important development issues, while considering implications
- Monitor, analyze, and anticipate 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 in 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 including leading preparation for meetings and communications.
- 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 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.

**Basel, Switzerland**:
Messeplatz 10
CH-4058
Basel
Switzerland

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