Skip to main content

Search jobs

Search jobs

Allergan Aesthetics

In Allergan Aesthetics, azienda del Gruppo AbbVie, sviluppiamo, produciamo e commercializziamo un portfolio di marchi e prodotti leader nel settore della medicina estetica. Il nostro portfolio include, tra gli altri, prodotti iniettabili per il trattamento del viso, il body contouring, la chirurgia estetica e la cura della pelle. Il nostro obiettivo è quello di fornire costantemente ai nostri clienti innovazione, istruzione, servizio eccezionale e impegno per l’eccellenza, il tutto con un tocco personale. Per maggiori informazioni, visita www.AllerganAesthetics.com.

Sr. Director, Regulatory Affairs Strategy -Device Aesthetics

Primary Irvine, California Secondary Branchburg Township, New Jersey; Pleasanton, California ID dell'offerta 2212664 Categoria Regulatory Affairs Divisione 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% (to include International Travel)

At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity and affirmative action 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. If you would like to view a copy of the company’s affirmative action plan or policy statement, please email CorpJat_ABV@abbvie.com.


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

Lavori più recenti

Registrati per ricevere le offerte di lavoro

Unisciti alla nostra rete di talenti per ricevere news e offerte di lavoro AbbVie nella tua email.

Interessato(a) aSeleziona una categoria o una sede. Clicca “Aggiungi” per creare la tua offerta di lavoro.

  • Regulatory Affairs, Irvine, California, Stati UnitiElimina
  • Regulatory Affairs, Branchburg Township, New Jersey, Stati UnitiElimina
  • Regulatory Affairs, Pleasanton, California, Stati UnitiElimina

I Termini d’uso, la Politica sui cookies e la Politica sulla privacy descrivono come raccogliamo e usiamo le informazioni e i diritti degli utenti. Ricevendo le informazioni confermi di aver letto questi documenti e di acconsentire a ricevere comunicazioni via SMS e offerte di lavoro via email da AbbVie.

Lavori visualizzati di recente

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. Click here to find out how you can avoid being a victim of job phishing scams.

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