Skip to main content

Search jobs

Search jobs

Over AbbVie

De missie van AbbVie is het ontdekken en leveren van innovatieve geneesmiddelen die vandaag een oplossing bieden voor ernstige gezondheidsproblemen en de medische uitdagingen van morgen aanpakken. We streven ernaar om een grote impact te hebben op het leven van mensen in verschillende belangrijke therapeutische domeinen: immunologie, oncologie, neurowetenschappen, oogzorg, virologie, vrouwengezondheid en gastro-enterologie, naast producten en diensten uit de portefeuille van Allergan Aesthetics. Bezoek www.abbvie.com voor meer informatie over AbbVie. Volg @abbvie op Twitter, Facebook, Instagram, YouTube en LinkedIn.

Associate Director / Director, Regulatory Affairs CMC (Cell & Gene Therapy)

Irvine, Californië Job ID 2206384 Categorie Regulatory Affairs Afdeling AbbVie

The Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) Combination Products and Medical Devices is responsible for combining knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured, or distributed to meet required legislation. Develops, actively mentors and supervises a team of global regulatory professionals who develop strategy for development and marketed products, and managers the content of global regulatory dossiers. Has influence and responsibility and is a key leader and a driver of regulatory policy and strategy. Influences the development and changes of regulations and guidance. Interfaces with outside regulatory agencies and trade associations and provides executive management with regulatory metrics and information. Individual may plan, direct, coordinate and control regulatory affairs activities related to products worldwide.

  • Leads a team of global regulatory professionals who develop strategy for development and marketed products including combination products and medical devices, and manages the content of global regulatory dossiers. Advises internal personnel on regulatory strategies
  • Key internal leader and driver of regulatory policy and strategy. Provides executive management with meaningful regulatory measurements and regulatory opinion
  • Advises management of the effect of current, newly finalized or proposed laws, regulations, guidelines and standards and on advisory committee recommendations.
  • Influences the development of regulations and guidance. Advances the organization’s goals by participating and taking leadership roles in professional associations, industry and trade groups as appropriate for assigned projects
  • Provides direction and guidance to exempt specialist and/or supervisory personnel who exercise significant latitude and independence in their assignments, may be asked to evaluate performance of and assist in career development planning for subordinates
  • Develops, communicates and builds consensus for operating goals that are in alignment with the company.
  • Provides leadership to organizational staff by communicating and providing guidance towards achieving department objectives.
  • Recommends modifications to the structure of organizational units or a centralized functional activity subject to senior management approval. Develops, communicates, and builds consensus for operating goals that are in alignment with the company. Creates 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
  • Makes decisions and provides guidance for handling and support for combination products and medical devices. Oversees regulatory team as they support combination products and medical devices.

  • Required Education: Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject
  • Preferred Education: Relevant advanced degree preferred
  • Required Experience: 12+ years pharmaceutical or industry related experience. 5+ years in quality systems and process improvement or regulatory affairs. Proven 7+ years in a leadership role with strong management skills
  • Experience working in a complex and matrix environment. Strong communication skills, both oral and written
  • Preferred Experience: 5-7 years in regulatory affairs. 10+ years pharmaceutical experience (medical device/combination product)
  • Experience developing and implementing successful global regulatory strategies. Interfacing ability with government regulatory agencies
  • Experience working with Health Authority
  • Note: Higher education may compensate for years of experience

*Position flexible based on 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)
Travel: Yes, 25 % of the Time
Job Type: Experienced
Schedule: Full-time
ABBVIE

Meest recente vacatures

Aanmelden voor job alerts

Sluit u aan bij ons talentennetwerk en ontvang nieuws en job alerts van AbbVie in uw mailbox.

Geïnteresseerd inSelecteer een categorie of locatie. Klik op ‘Add’ (toevoegen) om uw job alert aan te maken.

Onze Gebruiksvoorwaarden, ons Cookiebeleid en ons Privacybeleid leggen uit hoe we uw gegevens verzamelen en gebruiken en wat uw rechten zijn. Door ons uw gegevens te verstrekken, verklaart u deze documenten te hebben gelezen en gaat u ermee akkoord dat AbbVie u sms-berichten en job alerts per e-mail kan toesturen.

Onlangs bekeken functies

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