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Associate Director, Regulatory Affairs

Employer
AbbVie
Location
South San Francisco, CA
Start date
Apr 16, 2024

View more

Discipline
Regulatory, Regulatory Affairs
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay, Best Places to Work

Job Details


Company Description

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 immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.


Job Description

We are currently seeking a Regulatory Affairs Associate Director to join our growing regulatory team. In this role you would 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. 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. This position is based at AbbVie in the South San Francisco, CA location.

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 oncology 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 Health Authority meetings

Manage and participate in the creation, review, assembly and submission of regulatory documentation including INDs and CTAs and amendments, RFIs, annual reports

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 as assigned such as department initiatives, business development assessments, clinical assessments, and department training, etc.

Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)


Qualifications

Qualifications:

Bachelor degree in a life sciences, chemistry, or related discipline. Advanced degree preferred.

Associate Director - 5 7 years of experience in Regulatory Affairs (strong preference for experience in oncology) in the biotechnology or pharmaceutical industries, including an in-depth knowledge and understanding of the regulatory environment. International regulatory experience required. Director - 7-10 years of experience in Regulatory Affairs plus 3-5 years proven experience in a leadership role with strong management skills.

Demonstrated understanding of regulations and guidelines governing oncology drug development and ability to strategically apply to overall drug development

Demonstrated leadership ability in team settings

Strong written and verbal communication skills

Demonstrate expertise and knowledge of oncology and relevant indications

Key Leadership Competencies:

Builds strong relationships with peers and with partners cross functionally outside of team to enable higher performance

Learns fast, grasps the 'essence' and can change the course quickly where indicated

Raises the bar and is never satisfied with the status quo

Creates a learning environment, open to suggestions and experimentation for improvement

Embraces the ideas of others, nurtures innovation and manages innovation to reality


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 short-term incentive programs.
  • 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 Companys sole and absolute discretion, consistent with applicable law.

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

Company

AbbVie’s mission is to discover and deliver innovative medicines 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: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, and YouTube.

Stock Symbol: ABBV

Stock Exchange: NYSE

Company info
Website
Phone
1-800-255-5162
Location
1 North Waukegan Road
North Chicago
Illinois
60064
US

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