Director, Regulatory Affairs - Oncology Early Development

Regulatory Jobs; South San Francisco (CA); On-site; USD 180,000 - 260,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Global regulatory leadership

Regulatory strategy

Project management

Stakeholder management

Regulatory communications

Oncology knowledge

Education

Bachelor degree in life sciences or related

Advanced degree preferred

Job description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at

www.abbvie.com

. Follow @abbvie on

LinkedIn,

Facebook

,

Instagram

,

X

and

YouTube.

Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of both marketed products and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer.

AbbVie is focused on the discovery and development of novel oncology therapies. More than 1,000 AbbVie scientists, clinicians, and product developers with strong entrepreneurial roots work to combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments.

We are currently seeking a Regulatory Affairs Director to join our growing regulatory team. In this role you will be the Global Regulatory Lead where you will develop and implement global regulatory strategies to support the development of multiple oncology early development assets, contributing to the advancement of leading edge cancer research in a nimble, biotech –like environment within a large, well established pharmaceutical company.

The Director Regulatory Affairs Global Regulatory Lead in OED RA is responsible for developing and implementing global regulatory strategies to support the development of multiple oncology early development assets, contributing to the advancement of leading-edge cancer research in a nimble, biotech –like environment within a large, well established pharmaceutical company.

The GRL leads the Global Regulatory Product Team (GRPT). Project responsibilities may include Area Lead (US/Canada) role. May lead the Labeling Regulatory Strategy Team (LRST). Ensures strategic messaging in global regulatory dossiers and responses under guidance of management. Serves as the primary regulatory interface with the AST and supporting teams. Ensures compliance with global regulatory requirements. Demonstrates strong understanding of drug development and leadership behaviors consistent with level. Develop and implement acceleration strategies with guidance from supervisor.

This role provides leadership in the strategic guidance and execution of regulatory concepts within cross-functional project teams and supports interactions with global health authorities and corporate partners with regulatory deliverables.

Key Responsibilities

• Serve as the Global Regulatory Lead on project teams and key sub-teams
• Develop and implement competitive and effective global regulatory strategies for several products including clinical, nonclinical and CMC aspects and identify potential risks associated with proposed strategies
• Provide advice and guidance to project teams on the interpretation and application of relevant regulatory requirements and review processes
• Collaborate with AbbVie regional and country regulatory affiliates to support ex-US clinical development activities
• Present Regulatory strategies and issues at team and governance meetings
• Serve as primary Health Authority contact for assigned projects and foster positive and effective working relationships between project team members and Health Authority reviewers
• Prepare teams for and lead FDA and other Health Authority meetings
• Manage and participate in the creation, review, assembly and submission of regulatory documentation including clinical trial applications and amendments to these regulatory files, as appropriate
• Ensure consistency/completeness/adherence to standards for all regulatory submissions
• Coordinate and consult with other departments on the content, review of publication materials, and assembly of regulatory documentation
• Support non-program specific projects assigned such as department initiatives, business development assessments, clinical assessments and department training, etc.
• Required education: Bachelor degree in life sciences, chemistry, or related discipline.
• Preferred Education: Relevant Advanced degree preferred. Certification a plus.
• 5+ years of experience in Regulatory Affairs (strong preference for experience in oncology and/or cell and gene therapy) in the biotechnology or pharmaceutical industries, including an in-depth knowledge and understanding of the regulatory environment. International regulatory experience required. Some portion may include relevant exposure to pharmaceutical regulatory work (e.g., other R&D role or specialized training).
• Proven success in a strategic leadership role with strong project management skills. Experience working in a complex and matrix environment, and with multiple stakeholders. Demonstrated leadership ability in team settings
• Experience interfacing with government regulatory agencies.
• Demonstrated understanding of regulations and guidelines governing drug development and ability to apply these to overall strategic drug development
• Strong written and verbal communication and negotiation skills
• Demonstrated Business acumen and able to work under pressure
• Demonstrated expertise and knowledge of oncology