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Associate Director, Regulatory Affairs Innovation

Employer
AbbVie
Location
Irvine, CA
Start date
May 26, 2024

View more

Discipline
Regulatory, Regulatory Affairs
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Beach, Best Places to Work

Job Details


Company Description

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 https://global.allerganaesthetics.com/. Follow Allergan Aesthetics on LinkedIn.


Job Description

The Associate Director of Regulatory Innovation supports regulatory objectives for Allergan Aesthetics products including coordination, management of global submissions. Directs and supports development of the regulatory strategy with a focus on Clinical Outcome Assessment (COA) tools including digital and submission activities for device regulatory approvals in a variety of counties including EU, US, Japan, and China. Supports regulatory intelligence and policy activities in monitoring regulatory pathways, legislation updates, policies and initiatives that could impact initial product submissions, marketed products. Support Allergan Aesthetics at Regulatory Authority/Notified Body meetings as well as industry meetings. Supports due diligence activities and Agency audits/inspections as needed. The employee must carry out his/her responsibilities in compliance with all relevant laws, regulations and regulatory guidance as well as all company policies and procedures.

Responsibilities include:

  • Leads and/or supports medical device / pharma development, including Clinical Outcome Assessment tools and Digital Health Technologies, and global filing activities from a regulatory standpoint from initial product concept through life cycle management of the medical product.

  • Authors and s upports regulatory submissions, regulatory operations, change control, lifecycle management, interactions with regulatory agencies/Notified Bodies, technical file/design dossier management and approval of Declaration of Conformity as applicable. In addition, the incumbent is the key regulatory contact for Quality, Medical Safety and International Regulatory Affairs colleagues.

  • Provides regulatory policy, intelligence interpretation and strategy (e.g., Pharma and Medical Device Regulation) for medical products to support global regulatory plans.

  • Coordinates across the Allergan Aesthetics portfolio with the regulatory teams of each portfolio to provide consistent strategies for broad regulatory issues such as digital health t echnology and clinical outcome assessments

  • Acts as a key regulatory advisor to provide strategy and leadership by partnering with operating units on the implementation and training of regulatory requirements. Participates in and contributes to industry and professional meetings to maintain competency on regulatory policy issues.

  • Provides leadership, remains accessible and coaches employees when needed; maintains high levels of work and employee accountability.

  • Supports and develops global regulatory teams to meet company objectives .




Qualifications
  • Bachelors Degree in life sciences or engineering . Relevant advanced degree in a scientific discipline is highly desirable.

  • 8 years of regulatory experience in the medical device or pharma industry.

  • E xperience with D igital H ealth, Clinical Outcome Measurement preferred.

  • Experience in the CE Marking process, global regulatory strategy, and regulatory submission process.

  • Proven experience in and ability to manage relationships with regulatory agency personnel.

  • Strong knowledge of global regulatory intelligence and policy to analyze external regulatory trends and internal compliance trends, making recommendations to senior management to drive proactive initiatives to ensure compliance.

  • Strong knowledge of medical device and pharma regulations

  • Ability to travel up to 10% of time


Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

  • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
  • This job is eligible to participate in our short-term incentive programs.
  • This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion, consistent with applicable law.

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.

Company

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, and YouTube.

Stock Symbol: ABBV

Stock Exchange: NYSE

Company info
Website
Phone
1-800-255-5162
Location
1 North Waukegan Road
North Chicago
Illinois
60064
US

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