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Regulatory Affairs Director Lead

vor 1 Woche

Zürich, Zürich, Schweiz Planet Pharma Vollzeit

About Our Company

We are a biotech company dedicated to developing innovative therapies for challenging medical conditions.

Job Overview

This position offers a unique opportunity to join a dynamic team driving breakthrough treatments forward.

Key Responsibilities

  • Drive global regulatory strategies to achieve timely approval in key markets, ensuring strong product positioning.
  • Build relationships with regulatory authorities, including FDA, EMA, and others, leading negotiations and regulatory interactions.
  • Oversee INDs, CTAs, BLAs, and other regulatory filings, ensuring compliance with regulatory policies.
  • Provide regulatory leadership across pipeline projects, working closely with internal teams.
  • Guide the development of innovative therapies, navigating complex regulatory landscapes.
  • Lead regulatory submissions and approvals, ensuring compliance with regulatory policies.
  • Manage Health Authority meetings and regulatory engagements.
  • Identify potential regulatory challenges and develop solutions, including novel endpoint strategies.
  • Represent Regulatory Affairs in partnerships and due diligence activities.

Requirements

  • Advanced degree in Life Sciences (PhD, PharmD, or equivalent preferred).
  • 15+ years of experience in regulatory affairs within the biopharma industry.
  • Proven expertise in oncology regulatory pathways is a plus.
  • Strong track record of successful IND/CTA and BLA/MAA filings leading to regulatory approvals.
  • Extensive experience interacting with global regulatory agencies (FDA, EMA, etc.).
  • Ability to balance strategic vision with hands-on execution in a fast-paced environment.
  • Exceptional leadership, negotiation, and communication skills.
  • High ethical standards, professional integrity, and the ability to motivate cross-functional teams.