HireDiversity

Santa Barbara, CA, US

BIOLOGICS GLOBAL RA PROGRAM DIRECTOR-7051121010

Description

Mentor Worldwide LLC is currently recruiting for a Global Regulatory Affairs Director to support the Mentor franchise, based in Santa Barbara, CA or Somerville, NJ.

Mentor Worldwide LLC is a trusted global leader in aesthetic medicine among both consumers and clinicians by providing a broad range of innovative, science and clinical-based solutions to maintain, enhance, and restore self-esteem and quality of life. The company has products and services in three areas of aesthetics: breast (augmentation and reconstruction), body and face.

The main purpose of the Global Regulatory Affairs Program Director is to serve as Regulatory lead for the Mentor Biologics group through delivery of CMC expertise, regulatory strategy, and detailed project planning for the entire global regulatory program, including US, EU, Asia Pacific and Rest of World. The Mentor Biologics business is a multi-million dollar opportunity, and this role will manage all regulatory aspects of this portfolio globally.

This individual shall be responsible for strategic planning activities related to the regulatory affairs and CMC component of IND & BLA applications, supporting Manufacturing and Technical Operations to prepare CMC & non-clinical amendments, and managing the logistical activities of regulatory submission in eCTD format. This leadership role will also be responsible for facilitating the global strategic plan for registrations of Mentor Biologics products in non-US markets, including EU, Asia Pacific and rest of world, by managing relationships with regulatory affiliates and representatives of Johnson & Johnson throughout the world.

Long-term, the Global RA Program Director shall provide the team's strategic approach for the post-approval submissions (e.g. Annual reports, and notifications) to communicate post-market product changes to Regulatory Authorities, and submission documents in support of global dossiers for ex-US registration of new biologic products.

This individual will Serve as dedicated Regulatory representative to the Mentor Biologics Team through regular attendance, functional contribution, and tracking of action items. Serve as Regulatory representative at FDA and other regulatory interaction as necessary. Represent Regulatory functional expertise through communication of planned development activities or implementation plans, including risk mitigation as well as issues, achievements and milestones. Support the project team as the Global Dossier subject matter expert, for special regulatory projects, including the evaluation of the CRO's and Regulatory consultants. Responsible with Program Director to create and maintain regulatory project timelines. Track correspondence with FDA to ensure compliance to their requirements.

Responsible for managing and communicating upward, across and down all activities within Mentor Biologics through review of appropriate team documents including minute, plans and reports. Responsible for leading the Mentor Biologics team through the preparation and execution of agency interactions, including supporting creating of information packages for meetings, coordinating consultants, scheduling rehearsals and in planning and executing logistics for agency meetings. Support other preparation activities for agency meetings and major filings. Support team members in the development and global presentation of product registration data so as to ensure timely global registration of new products, indications, and labeling. As needed, provide operations support including operational project management and implementation of functional projects.

Qualifications


BA/BS degree is required; an advanced degree is strongly preferred. A minimum of 5 years experience in a Senior Regulatory Affairs role within the Biotech or Pharmaceutical industry is required. Experience leading or managing a large project while in a Senior Regulatory Affairs role is required. Experience in preparing CTD dossiers is required. Strong knowledge of regulatory requirements (21 CFR Parts 312, 600, 601, 610, 820) is required. Experience selecting/managing outside vendors is required. Experience processing electronic submissions is preferred. Global experience in biologics registrations is preferred. Travel both domestic & international, approximately 25%, but may go up to 80% during peak times with regular travel to manufacturing facility is required. PMP or other Project Management training is preferred.

This position will be based in Santa Barbara, CA or Somerville, NJ.

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-California-Santa Barbara
Other Locations:North America-United States-New Jersey-Somerville
Organization: Mentor Worldwide LLC (6177)