Global Regulatory Lead, Oncology Early Development

Regulatory Jobs; South San Francisco (CA); In loco; USD 180.000 - 260.000; Tempo pieno

Descrizione del lavoro

AbbVie is seeking a Regulatory Affairs Director to join our regulatory team as Global Regulatory Lead. You will craft and execute global regulatory strategies to advance oncology assets and lead cross-functional teams within a large, established pharmaceutical company.

The role requires a life sciences degree, 5+ years in Regulatory Affairs with international experience, and proven leadership with strong communication.

Competenze

• 5+ years in Regulatory Affairs, oncology experience preferred.
• International regulatory experience required.
• Strong leadership and program management skills.
• Excellent written and verbal communication and negotiation skills.

Mansioni

• Serve as Global Regulatory Lead on project teams and sub-teams.
• Develop and implement global regulatory strategies for oncology assets.
• Provide advice on interpretation of regulatory requirements and review processes.
• Collaborate with US/Canada and ex-US regulatory affiliates to support development activities.
• Lead regulatory strategy discussions at governance meetings and Health Authority meetings.
• Prepare regulatory documentation and ensure consistency and standards across submissions.

Conoscenze

Global regulatory leadership

Regulatory strategy

Project management

Stakeholder management

Regulatory communications

Oncology knowledge

Formazione

Bachelor degree in life sciences or related

Advanced degree preferred

Descrizione del lavoro

AbbVie is seeking a Regulatory Affairs Director to join our regulatory team as Global Regulatory Lead. You will craft and execute global regulatory strategies to advance oncology assets and lead cross-functional teams within a large, established pharmaceutical company.

The role requires a life sciences degree, 5+ years in Regulatory Affairs with international experience, and proven leadership with strong communication.