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Associate Director, Regulatory Affairs, US/Canada (Oncology)

Employer
AbbVie
Location
North Chicago, IL
Start date
Mar 18, 2024

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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
  • Makes decisions and plans for operations (work flow, assignments, staff development) within area of responsibility with minimal direction. Sets strategy and leads cross-functional/multidisciplinary therapeutic teams and multidivisional initiatives. Operates independently, with recognition of when to consult departmental senior concerning risks.

  • Assists in the management of the departmental budget, identifies and communicates budgetary needs to Operations and Finance, and identifies and projects current and future expenditures and business needs.

  • Collects and analyzes issues/trends that affect business to identify and act on cross-organization or cross business opportunities. Uses knowledge of global marketplace, technology and business levels effectively.

  • In absence of Director, is responsible for day-to-day operations, and departmental initiatives, which have significant impact on both internal and external customers. Manages direct reports and/or assists in the development, training, and mentoring of staff members. Encourages innovation and holds employees accountable for delivering on their goals; recognizes, mentors, rewards and recommends promotion for staff members based on their performance, results, and development.

  • Represents A&A on Global Regulatory Product Team (GPRT) and ASTs as appropriate. Advises on regional specific requirements and provides strategic input.

  • Serves as Health Authority liaison and interfaces with Health Authority for meetings, teleconference, etc. Coordinates preparation of Health Authority meeting briefing packages

  • Solid understanding of regulations and guidance of regulatory authorities, political and legal climate and industry practices to assist in meeting organizational goals. Possess and leverage broad industry knowledge. Coordinates and prepares submissions in line with Health Authority regulatory requirements and guidelines.

  • Manages interface with Health Authority for key projects/issues, including direct negotiation with review division personnel. Coordinates and prepares submissions in line with Health Authority regulatory requirements and guidelines.

  • Manages the preparation and review of regulatory submissions to assure effective presentation of data, complete and timely response to Health Authority during application review, and quality consistent with Health Authority regulatory requirements and guidelines.

  • Manages direct reports and/or assists in the development, training, and mentoring of staff members.

Significant Work Activities -Keyboard use (greater or equal to 50% of the workday)


Qualifications
  • Required Education: Bachelors Degree (pharmacy, biology, pharmacology) or related life sciences

  • Preferred Education: Relevant advanced degree is preferred. Certification a plus

  • Required Experience: 8 years Regulatory, R&D or industry related experience

  • Extensive experience interfacing with government Agencies and Health Authority personnel. Experience working in a complex and matrix environment

  • Demonstrated success in negotiation skills, strategic thinking, and credibility within the organization. Strong communication skills, both oral and written

  • Preferred Experience: 5 years in regulatory pharmaceutical affairs

  • Strong leadership presence with prior management experience

  • Experience developing and implementing successful global regulatory strategies

***Experience may determine level of position. Senior Manager or Associate Director.


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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