AbbVie

Senior Manager, Regulatory Affairs

Employer
AbbVie
Location
Madison, New Jersey
Posted
Nov 12, 2021
Ref
2116710
Required Education
Bachelors Degree
Position Type
Full time
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 

The Sr. Manager, Regulatory Affairs serves as Regulatory Lead for development-stage and mature pharmaceutical products.  He/She will manage, review, plan and prepare complex regulatory submission documents for US and Canada regulatory filings. Also, the Sr. Manager will interpret local regulations, and provide regulatory guidance to global regulatory teams.  Has authority to submit complex submissions, act as primary AbbVie contact with US FDA, and lead US FDA meetings. Ensures technical accuracy and regulatory compliance of submissions. May train and provide guidance to lower level staff. 

As a Regulatory Lead, the Sr. Manager will drive the US and Canada regulatory strategy, advising on non-clinical and clinical development programs for assigned projects in line with business goals and objectives.  Additionally, He/She will provide regulatory affairs perspective to project teams and other functions. Will support management with development and implementation of departmental strategies and policies.  Primary product responsibility is in the Neuroscience Therapeutic Area. May have responsibility to work in one or more therapeutic areas, covering multiple projects as needed. 

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.

You Will  

  • Be responsible for providing regulatory input into project teams, Global Regulatory Plans, and Global Regulatory Project Teams.
  • Be responsible for ensuring planned drug development activities comply with health authority guidelines and in cases where they do not, provides a critical analysis of associated risks and issues.
  • Make recommendations to Regulatory Management and drug development teams in order to shape the area/affiliate strategy in line with commercial objectives.
  • Ensure Alignment with cross functional teams.
  • Establish relationships with US and Canada colleagues as well as global regulatory teams 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 and Canada health authority meetings.
  • Be responsible for US and Canada specific submissions.  
  • Manage the preparation of clinical trial-supporting submissions.
  • Define US and Canada submission strategies, identifying risks and issues.
  • Be responsible for 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 development, lifecycle management and/or maintenance.
  • Ensure input from Advertising and promotional compliance team, as appropriate.
  • Act as the primary contact with Regulatory Agencies for assigned regions
  • Plan and implement regulatory activities in support of lifecycle management (e.g. Annual reports, label updates and CMC changes).
  • Submit product labeling in compliance with legal/regulatory requirements and communicates planned/approved changes to relevant functions.
  • Ensure effective implementation of filing plans and publishing of documents for assigned programs.
  • Ensure effective planning, oversight and management of submissions including VDoc preparation and EDMS entries of assigned projects.
  • Ensure archiving of correspondence according to department policies and procedures, especially submissions, internal memos and key correspondence.
  • Be responsible for the issuing Notification of Regulatory Agency Correspondence, Submissions, and Approvals according to department policies and procedures
  • Provide project teams with clear constructive regulatory advice and intelligence to maximize business opportunities.
  • Define regulatory requirements, develop, and subsequently implement, plans in support of regional/country business initiatives.
  • Maintains a performance and improvement culture.
  • Follow all approved AbbVie procedures and guidance.
  • Prepare and deliver presentations as required   

Qualifications

Qualifications

Basic:

  • Bachelor's Degree (or equivalent)
  • 5-10 years of experience in pharmaceutical industry with a minimum of 5 years in Regulatory Affairs.  

Note: Higher education may compensate for years of experience.

 

Preferred:

  • Bachelor's, Master’s, or Doctorate Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields.  
  • 5-10 years of experience in Regulatory Affairs
  • Experience with NDA/MAA submissions and direct interactions with Health Authorities

Key AbbVie Competencies:

  • Strong negotiation skills, oral and written communication skills, and influencing skills to ensure completion of assigned tasks
  • Self-Motivated, independent thinker, able to work in a matrixed environment

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 10 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
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.