Associate Director, Regulatory Affairs US & Canada (Oncology)
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 Associate Director, Regulatory 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 registration maintenance.
Responsibilities : 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
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
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
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
Experience developing and implementing successful global
Flexibility to become a Senior Manager depending on
Significant Work Activities
Keyboard use (greater or equal to 50% of the workday)
Continuous sitting for prolonged periods (more than 2
consecutive hours in an 8 hour day)
Yes, 10 % 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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