Director, RA Global Regulatory Strategy
Company: AbbVie, Inc.
Posted on: February 22, 2021
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 Director Regulatory Affairs Global Regulatory Lead,--Global
Regulatory Strategy, is responsible for developing and implementing
global, US and Canadian regulatory strategies to secure and
maintain market approval in the assigned therapeutic area. Leads
the Global Regulatory Product Team (GRPT), expands TA knowledge,
and manages strategic messaging and content of global, US and
Canadian regulatory dossiers. Serves as the primary regulatory
interface with ADT and supporting teams. Proactively anticipates
and mitigates regulatory risks. Ensures compliance with global
regulatory requirements. Demonstrates understanding of drug
development and leadership behaviors consistent with level.
Develops and implements acceleration strategies. Ensures alignment
of global regulatory strategies with Sr. management. May have
- Leads a team of global regulatory professionals for development
and marketed products. Accountable for ensuring that corporate
goals are met. Manages the content of global regulatory dossiers.
Key internal leader and driver of regulatory policy and strategy
for assigned products.
- Leads preparation of global, US and Canadian regulatory product
strategies for assigned products. Leads regulatory team in the
preparation and maintenance of risk assessment and mitigation
strategy development for assigned products.
- Acts independently under the direction of a GPS TA Head. May
participate in or lead initiatives. Based on experience and
scientific strengths, expands TA knowledge of TA; provides coaching
and mentoring for GRPT members. May have direct report and
contributes to the performance management for other RA team
members. Influences the development of regulations and guidance.
Advises management of the effect of current or proposed laws,
regulations, guidelines and standards, etc.
- Advises internal personnel on regulatory strategies. Follows
company policies and procedures for regulatory record keeping and
may develop and implement policies and procedures within the RA
department and , if applicable, ensures direct reports follow
- Ensures alignment of global regulatory strategies with Sr.
Management. Proactively informs ADT and management of issues, risks
and mitigations. Provides assessment of impact on global, US and
Canadian programs. Provides informed regulatory opinion based on
experience and expertise.
- Works with GRPT to develop, communicate goals that are in
alignment with the business goals. Under supervision of a Director
or TA Head, communicates to regulatory team and cross-functionally
the immediate to long-range plans to carry out objectives
established by executive management.
- Makes decisions regarding work processes or operational plans
and schedules in order to achieve the program objectives
established by senior management. Advances the organization's goals
by participating and taking leadership roles in professional
associations, industry and trade groups as appropriate for assigned
- Follows budget allocations and keeps supervisor informed on
- Required Education:
Bachelor's degree in life sciences (pharmacy, biology, chemistry,
pharmacology) or related subject.
- Preferred Education:
Relevant advanced degree is preferred. Certification a plus.
- Required Experience:
7+ years regulatory experience. Some portion may include experience
related to pharmaceutical regulatory work (e.g., other R&D role
or specialized training). Requires drug development experience in
Proven 3-5 years in a leadership role with strong management
Experience working in a complex and matrix environment with
multiple stakeholders and on cross-functional teams.
- Required Experience cont'd:
Strong communication and proactive negotiation skills. Experience
contributing to enterprise management of a portfolio of
Experience interfacing with government regulatory agencies.
Experience developing and implementing successful global regulatory
- Preferred Experience:
10 years' experience in pharmaceutical regulatory activities;
preferably with experience as lead regulatory product strategist in
two or more major regions such as EU or Japan.
Strong clinical foundation preferred with business acumen.
Note: Higher education may compensate for years of 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, 15 % 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., Santa Rosa , Director, RA Global Regulatory Strategy, Executive , Clearlake, California
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