Madison, New Jersey; New Jersey, United States
Research & Development
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 .
Envision working with energetic colleagues and inspirational
leaders. Now, place yourself in that mix; leading discussions,
asking the right questions and driving results.
What Your New Manager Wants You to Know
In this new and exciting position, the Manager, Regulatory
Affairs primarily serves a supportive role to the Global Regulatory
Lead for development-stage pharmaceutical products. The Manager
serves as the Regulatory Lead for mature products while managing,
reviewing, planning and preparing complex regulatory submission
documents for global regulatory filings. Among other
responsibilities, the Manager will interpret regulations, and
provide regulatory guidance to global regulatory teams. He/She has
the authority to submit complex submissions and may act as primary
AbbVie contact with US FDA and may lead selected US FDA meetings
while ensuring technical accuracy and regulatory compliance of
submissions. He /She may train and provide guidance to lower level
In Regulatory Lead or supportive role, the Manager drives global
regulatory strategy, advising on CMC, non-clinical and clinical
development programs for assigned projects in line with business
goals and objectives as well as provides regulatory affairs
perspective to project teams and other functions.
Lastly, the Manager supports management with development and
implementation of departmental strategies and policies.
YOU ARE more than just a title, YOU ARE…
A strategic thinker : align and excite internal stakeholders to
facilitate success through strong leadership, strategic thinking
and personal drive.
First class team player : collaborate across multiple
disciplines to ensure compliance and ability to influence
cross-functional teams and senior leadership.
Provide appropriate Regulatory input to project teams via Global
Ensure planned drug development activities comply with health
authority guidelines, and in cases where they do not, provide a
critical analysis of the associated risks and issues.
Make recommendations to GRL and/or drug development teams in
order to shape the global strategy in line with regional/commercial
Establish relationships with colleagues as well as global
regulatory team thereby ensuring local RA activities are in line
with global and regional business priorities.
Support the drug development strategy, defining options for
Scientific Advice, creating briefing packages and coordinating and
leading US health authority meetings.
Be responsible for US specific submissions (strategy and package
Manage the preparation of clinical trials and submissions and
routine CT maintenance.
Support the communication of regulatory strategy in support of
new product registration, in line with commercial objectives.
Ensure that teams and functional groups are provided with clear,
constructive regulatory advice and intelligence to assist planning
and issue resolution during product development and
Ensure input from Advertising and Promotional Compliance team,
Develop an awareness of key individuals within the Regulatory
Agencies, to ensure a clear understanding of requirements and
effective representation of AbbVie.
Act as primary contact with US FDA as required.
Plan and implement regulatory activities in support of lifecycle
management (e.g Annual reports, label and CMC changes).
Submit product labeling in compliance with legal/regulatory
requirements and communicate planned/approved changes with APC,
medical affairs and marketing.
Ensure effective implementation of filing plan and publishing of
Ensure effective planning, oversight and management of
submissions including Virtual Document preparation and RAPID
Ensure archiving of activities, especially submissions, internal
memos and key correspondence.
Provide status updated to management.
Be responsible for communication of submission and approvals to
relevant cross functional teams.
Provide project teams with clear, constructive regulatory advice
and intelligence to help maximize business opportunities.
Define regulatory requirements, develop and subsequently
implement plans in support of global/regional/country business
Provide input into development of processes to leverage AbbVie
global processes and infrastructure and maximize efficiency and
Provide input into critical metrics and management reports.
Take personal responsibility for the Notification of Regulatory
activities and related database entry/data accuracy for allocated
Maintain a performance and improvement culture.
Ensure roles and responsibilities for external services within a
project are clearly defined and documented.
Proactively resolve issues related to outsourced activities.
Follow all approved AbbVie procedures and guidance.
Ensure that budgets and forecasts are developed, and actuals
managed in line with regional requirements.
Bachelors degree required. Advanced degree preferred.
3 -5 years’ regulatory affairs experience
In this role, we’re looking for a leader who will :
Act as an Owner
Be Excellence Focused
Act as an Influencer
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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