Skip to main content

Search jobs

Search jobs

About Allergan Aesthetics

At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit www.AllerganAesthetics.com.

Sr. Director, Regulatory Affairs Strategy -Device Aesthetics

Primary Irvine, California Secondary Branchburg Township, New Jersey; Pleasanton, California Req ID 2212664 Category Regulatory Affairs Division Allergan Aesthetics

 

The Sr. Director Regulatory Affairs (Devices) is independently responsible for development of global regulatory strategy and representation of Regulatory Affairs on R&D project teams.  Communicates regulatory strategy to project teams developing pharmaceutical or medical device Leads team of regulatory professionals to ensure successful planning and completion of regulatory activities on a worldwide basis.  Responsible for knowledge of regulatory requirements of major regions (US, EU, Japan and China) with responsibility for working with colleagues on a worldwide basis to form a global strategy.  Responsible for content of global regulatory submissions.  Directs communications and interactions with US FDA and other regulatory agencies worldwide.  Responsible for covering multiple development projects.

Responsibilities:

Advisory Responsibilities:

Represents Department at Global Project Team.  Develops regulatory strategic plan and provides guidance to project team.  Leads Global Regulatory Team.  Works with team to resolve complex project issues.  Utilizes regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure governmental approvals are obtained. Manage and mentor direct report(s), where line management responsibilities exist.

Submissions:

Sets strategy for submissions of product registration documents to health authorities worldwide.  Interacts with other line functions in the preparation, review, and completion of documents for regulatory submissions.

Communications:

Able to clearly articulate regulatory strategy at Project Team and Global Regulatory Team meetings.  Able to negotiate with teams to ensure acceptance of regulatory strategy.  Ensures compliance with project team timelines and milestones.

Health Authority Interactions:

Effectively plan, organize, and conduct (or supervise) formal meetings with regulatory agencies.  Interact with key personnel in regulatory agencies to ensure the review and approval of development plans, the timely resolution of issues, and the approval of marketing applications.

Regulatory Compliance:

Provide interpretive analyses of complex regulatory guidance documents, regulations, or directives that affect Allergan Aesthetics products and operations. Advise personnel in other departments regarding their applicability and effect.-PD1

 


Qualifications - External

  • PhD, PharmD or MD degree or equivalent in a scientific field, plus at least 10 years’ experience in Regulatory Affairs with successful leadership roles on global project teams
  • MS degree or equivalent in a scientific field, plus at least 12 years’ experience in Regulatory Affairs with successful leadership roles on global project teams
  • BS degree or equivalent in a scientific field, plus at least 15 years’ experience in Regulatory Affairs with successful leadership roles on global project teams
  • Demonstrated excellence in developing global regulatory affairs strategy.
  • Strategic thinking, leadership skills, assertiveness, strong technical background, and excellent negotiation and project management skills as evidenced by past performance as regulatory lead on global project teams
  • Able to analyze worldwide regulatory requirements to synthesize a global regulatory development strategy as evidenced by past regulatory experience
  • Excellent interpersonal skills
  • Exceptional communication skills (verbal and written) as evidenced by a demonstrated ability to prepare complex documents / submissions and to give presentations
  • Experience working in a matrixed environment 
  • Ability to work independently
  • Ability to travel for up to 20%s

Significant Work Activities: N/A
Travel: No
Job Type: Experienced
Schedule: Full-time
ABBVIE

Most recent jobs

Sign up for job alerts

Join our talent network and receive AbbVie news and job alerts to your inbox.

Interested InPlease select a category or location option. Click “Add” to create your job alert.

  • Regulatory Affairs, Irvine, California, United StatesRemove
  • Regulatory Affairs, Branchburg Township, New Jersey, United StatesRemove
  • Regulatory Affairs, Pleasanton, California, United StatesRemove

Our Terms of Use, Cookie Policy and Privacy Policy explain how we collect and use information about you and the rights you have. By submitting your information, you acknowledge you have read those documents and consent to receive SMS communications and email jobs alerts from AbbVie.

Recently viewed jobs

You have not viewed any jobs recently.

Phishing scam alert

As an online job seeker, you could be a target of cyber (online) thieves seeking to secure personal information from you by sending you “phishing” messages.

Please be alert to and protect yourself from phishing scams. Find out how you can avoid being a victim of job phishing scams.

For Internal Candidates only - Notice of Filing of Labor Condition Application

Equal Employment Opportunity | Reasonable Accommodation