Regulatory Affairs Director - Global Regulatory Lead (OED RA)

Job title: Regulatory Affairs Director - Global Regulatory Lead (OED RA)

Qualification

• 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

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.

• Benefits and Additional Information

• Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our long-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

• AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

• US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html