Full-Time Global Regulatory Lead

Single point of contact/single point of accountability within GRA on the Core Asset Team (CTA) and Medicines Development Team (MDT) for assigned program(s).

Chairs a Global Regulatory Team (GRT) of regulatory Subject Matter Expert(s).

Provides global regulatory leadership of assigned program(s).

Develops global regulatory strategies, including risk assessment and mitigation strategies. Champions use of expedited regulatory pathways globally to accelerate patients’ access.

Attends major/critical regulatory Agency meetings (US FDA, EMA/CHMP, PMDA, NMPA/CDE) for assigned program(s).

May act as the European or US Regulatory Strategy lead (jointly with GRL role) depending on the complexity of the program and stage of development.

May present to Senior Leadership regarding assigned program(s).

Cooperates with other departments and affiliates within Sobi, regulatory authorities, partners and regulatory consultants.

Participates in strategic and regulatory evaluations of in-licensing matters.

May have direct oversight of Regulatory Affairs team members supporting assigned program(s). Develops and coaches direct reports.

Authority to approve services and costs within budget and delegation from Sobi authorized signatories.

Review regulatory SOPs as needed.

Participate in operational excellence work (improvement projects) as needed.

Main contacts:

• Internal core interactions: All functions within Sobi, but in particular Commercial, Pharmacovigilance & Patient Safety, Supply Chain, Quality, Manufacturing & Supply, Clinical Development, Global Medical & Scientific Affairs, Project & Portfolio Management as well as Management Teams, Governance Teams and affiliates.
• External core interactions with: Regulatory Authorities, CROs, Consultants, Partners.

May act as point of contact with US FDA or EMA.

Degree in Life Sciences

Expert on all Regulatory Affairs processes, applications and regulatory environment to achieve and maintain marketing authorizations.

Good knowledge of drug development and the rare diseases regulatory environment.

Very good knowledge in written and oral English, knowledge of other languages is an upside but not required.

Personal attributes:

• Strong team-player with collaborative, respectful and flexible attitude and high engagement
• Highly self-motivated and able to drive activities, solution-oriented personality
• Excellent communication and negotiation skills

The suitable candidate should demonstrate the Sobi Values; Care for our patients, for our colleagues and for our company, Ambition, Urgency, Ownership and Partnership.

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