Senior Manager/Associate Director, Regulatory Affairs, US & Canada
Company: AbbVie, Inc.
Posted on: February 25, 2021
Senior Manager/Associate Director, Regulatory Affairs, US &
- Lake County, United States of America
- Regulatory Affairs
- 2009770 Job Description About AbbVie
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 , YouTube and LinkedIn .
The Senior Manager/Associate Director, Regulatory Affairs, US &
Canada--defines and implements regulatory strategies and priorities
in conjunction with Global Regulatory Lead and the GRPT, as
appropriate. Ensures application of established policies and best
practice regulatory standards within its region for all filings,
maintenance of existing product registrations and agency
interactions. Acts independently or under supervision. Has division
level influence, responsibility, is a key opinion leader and an
expert resource within AbbVie. May serve as primary regulatory
contact with Health Authority. Assists Regulatory staff by
outlining regulatory strategy and providing data needed to support
filings, responses to Health Authorities inquiries, and
- 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
- 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
ADTs 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
- Manages direct reports and/or assists in the development,
training, and mentoring of staff members.
- Required Education: Bachelor's 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
- Extensive experience interfacing with government Agencies and
Health Authority personnel. Experience working in a complex and
- 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
- Strong leadership presence with prior management
- Experience developing and implementing successful global
regulatory strategies*Position is flexible based on experience
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive
hours in an 8 hour day)
Keyboard use (greater or equal to 50% of the workday)
Yes, 5 % of the Time
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse
backgrounds to develop new and innovative solutions for patients.
As an equal opportunity employer we do not discriminate on the
basis 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, protected veteran status, or
any other legally protected characteristic.
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Keywords: AbbVie, Inc., Chicago , Senior Manager/Associate Director, Regulatory Affairs, US & Canada, Executive , Chicago, Illinois
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