Director, Global Regulatory Affairs - Irvine, United States - AbbVie

AbbVie Irvine, United States

1 month ago

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Description

Job Description

Job DescriptionCompany Description

AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

The Director of Regulatory Affairs – Soft Tissue Fillers MPS supports regulatory objectives for the company's soft tissue fillers devices for marketed products support (MPS) including coordination, management of global submissions to support renewals. Directs and supports development of the regulatory strategy related to MPS activities for device regulatory activities in a variety of counties including but not limited to US, EU, US, Japan, and China.

Supports regulatory intelligence and policy activities in monitoring regulatory pathways, legislation updates, policies and initiatives that could impact marketed products. Supports 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:

Leads team and provides regulatory guidance to ensure compliance with applicable medical device regulations for marketed products.
Manages direct reports; maintains high levels of work and employee accountability, further develop the team to ensure a quality mindset.
Provides leadership and expertise for: regulatory operations, change control, lifecycle management, interactions with regulatory agencies/Notified Bodies, technical file/design dossier management and approval of EC Declaration of Conformity as applicable.
Facilitates future changes related to manufacturing transfers, Pringy manufacturing facility future changes (new equipment, aseptic fill, clean rooms)
Assist the team in supporting regulatory interactions with Quality, Medical Safety and International Regulatory Affairs colleagues.
Provides regulatory policy, intelligence interpretation and strategy (e.g., Medical Device Regulation) for medical devices to support global regulatory plans, due diligence, integrations, and divestitures.
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.
Supports and develops global regulatory teams to meet company objectives.

Qualifications

Bachelor's degree or equivalent. Relevant advanced degree in a scientific discipline is highly desirable.
At least 10 years of regulatory experience in the medical device industry and or pharma.
Significant Team management and development experience to mentor junior staff and ensure adequate resources exist to support development and commercial products.
Strong knowledge of medical device regulations, and desired 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.
Drive proactive initiatives to ensure compliance.
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 Company's 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 AbbVie's 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.

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