Senior Associate or Manager, RA Aesthetics, Regulatory Affairs

Company 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 www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. 

Job Description

Job SUMMARY:

• The Regulatory Affairs Manager (medical device group) will be responsible for ensuring first time approval of new products and new indications for existing products through educating to his or her managers and staffs.


• And will be responsible for contributing to the development of Medical Aesthetic business from the perspective of regulatory strategy

Key duties and responsibilities:

• Develop local regulatory strategies and plan for major submissions to register new medical devices or new indications with Senior Manager of Regulatory Affairs and agree local submission timelines


• Lead the strategic discussion to accelerate development for projects. Based on the strategy we developed, negotiate with the regulatory authorities, and prepare for the early submission


• Ensure Japan submission requirements are communicated to relevant regional and global regulatory team


• Determine local Regulatory Risk for submissions and risk mitigation strategies where relevant


• Maintaining regulatory records for assigned product portfolio in compliance with local and global procedures


• Manage interactions with PMDA and MHLW and maintain a productive working relationship


• Participate in / coordinate special project assignments as determined by the Senior Manager of Regulatory Affairs

Qualifications

job QUALIFICATIONS (MINIMUM REQUIREMENTS):

Education and Experience

• Bachelor's degree in science (biology, chemistry, microbiology, medical technology, pharmacy, dentistry), math, engineering, physics, metallurgy, or medical related fields is required


• More than 5 years related experience in regulatory affairs, including regulatory strategy and regulatory maintenance in medical device field


• Must have medical device experience

Essential Skills, Experience, and Competencies (includes Licenses, Credentials)

• Ability and desire to create results


• Requires excellent written and verbal communications in Japanese and business level communications in English


• Ability to effectively work under tight deadlines and manage projects independently.


• Resourcefulness in solving problems


• Cutting-edge regulatory knowledge of medical device


• Excellent people management skills, strong proven leadership and an upbeat and enthusiastic attitude

Additional Information

AbbVie is an equal opportunity employer and 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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html 

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html