Global Head of Regulatory Strategy

Vor 4 Tagen


Zürich, Zürich, Schweiz Planet Pharma Vollzeit

About This Opportunity

We are seeking a seasoned expert to lead our regulatory team and drive global regulatory strategies.

Responsibilities

  • Develop and execute global regulatory strategies to achieve timely regulatory approval in key markets, ensuring strong product positioning.
  • Establish and maintain effective relationships with regulatory authorities, including FDA, EMA, and others.
  • Oversee the preparation, submission, and maintenance of INDs, CTAs, BLAs, and other regulatory filings.
  • Provide regulatory leadership across pipeline projects, working closely with internal teams.
  • Guide the strategic development of innovative therapies, navigating complex regulatory landscapes.
  • Lead regulatory submissions and approvals, ensuring compliance with evolving regulatory policies.
  • Manage and coordinate Health Authority meetings and regulatory engagements.
  • Identify potential regulatory challenges and develop proactive 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.


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