Vice President Regulatory Affairs

Medella Life; Remote; EUR 120.000 - 160.000; Vollzeit

Zusammenfassung

A growing pharmaceutical organisation is seeking a Vice President of Regulatory Affairs based in Germany. This executive role involves leading regulatory strategies and ensuring compliance across various functions to support product launches throughout Europe. Candidates should have over 15 years of experience in Regulatory Affairs, deep knowledge of German and EU regulations, and strong leadership skills. This position offers the flexibility of remote work while providing an opportunity to impact patient access and commercial success.

Qualifikationen

• 15+ years’ experience in pharmaceutical Regulatory Affairs with senior leadership responsibility.
• Strong experience with German regulatory authorities and European regulatory frameworks.
• Proven track record of successful regulatory submissions.

Aufgaben

• Define and implement regulatory strategies for clinical programmes in Germany and the EU.
• Lead regulatory submissions and approvals, including CTA, MAA, and variations.
• Build and mentor a high-performing Regulatory Affairs team.

Kenntnisse

Leadership

Strategic thinking

Stakeholder management

Regulatory knowledge

Fluent English

Ausbildung

Advanced degree in Life Sciences, Pharmacy, Medicine, or related discipline

PhD or MD preferred

Jobbeschreibung

Role Overview

We are representing our client in the search for a Vice President, Regulatory Affairs, based in Germany (remote). This role provides executive-level responsibility for leading the regulatory function and shaping regulatory strategy across Germany and Europe within a growing pharmaceutical organisation.

You will define and execute regulatory strategies covering clinical development, marketing authorisations, and lifecycle management of pharmaceutical products. Acting as the primary interface with regulatory authorities. You will ensure regulatory considerations are embedded across R&D, Clinical Development, Quality, and Commercial functions to support efficient development timelines and successful product launches.

Key Responsibilities

These responsibilities cover strategy, operations, leadership, external representation, and the candidate profile.

Regulatory Strategy & Leadership

• Define and implement regulatory strategies for clinical programmes and product registrations in Germany and the EU
• Advise the Executive Board on regulatory risks, opportunities, and compliance considerations
• Align regulatory strategy with corporate objectives to maximise patient access and commercial outcomes

Regulatory Operations

• Lead regulatory submissions and approvals, including CTA, MAA, variations, renewals, and post-approval commitments
• Manage interactions with BfArM, PEI, EMA, and other relevant health authorities to facilitate approvals and resolve regulatory issues
• Ensure compliance across the full product lifecycle, including post-marketing obligations and safety commitments

Team Leadership & Development

• Build, mentor, and lead a high-performing Regulatory Affairs team across clinical, CMC, and lifecycle activities
• Drive cross-functional collaboration to ensure regulatory requirements inform early-stage development and commercialisation planning

External Representation

• Represent the company in discussions with regulatory authorities, industry associations, and professional forums
• Establish strategic relationships to strengthen the company’s regulatory credibility and visibility in Germany and Europe

Candidate Profile

• Advanced degree in Life Sciences, Pharmacy, Medicine, or a related discipline; PhD or MD strongly preferred
• 15+ years’ experience in pharmaceutical Regulatory Affairs, including significant senior leadership responsibility
• Strong experience with German regulatory authorities (BfArM, PEI) and European regulatory frameworks (EMA)
• Proven track record of leading successful regulatory submissions and approvals across multiple therapeutic areas
• Solid understanding of clinical development, CMC, and product lifecycle management
• Strong leadership, strategic thinking, and stakeholder management skills
• Experience leading remote and cross-border teams
• Languages: Fluent English (Required) & German (Preferred)