Offer summary

Qualifications:

Bachelor's degree in a relevant field; advanced degree preferred., Extensive experience in regulatory affairs, particularly in healthcare or pharmaceuticals., Strong understanding of regulatory requirements and standards (e.g., ISO, 21 CFR)., Proven leadership skills with experience in managing and mentoring teams..

Key responsibilities:

Lead coordination of regulatory activities across organizational units.

Develop and implement regulatory strategies and ensure compliance with regulations.

Prepare and submit regulatory submissions to authorities in various geographies.

Communicate effectively with internal stakeholders and regulatory agencies to ensure submission approvals.

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

People Leader

All Job Posting Locations:

Chuo-ku, Tokyo, Japan

Job Description:

Collaboratively interface with a variety of levels on significant matters, frequently leading the coordination of activity across organizational units
Manage, mentor, and develop direct reports to meet individual and company goals and objectives
Develop, follow, and train key personnel on regulatory policies, processes and SOPs
Develop and implement regulatory strategies and update strategy based upon regulatory changes
Determine submission and approval requirements in assigned geographies and establish work plans/delegate assignments to team in order to effectively meet the requirements
Provide strategic input and technical guidance on regulatory requirements to Regulatory, product development and operations teams
Work with product development, quality and operations functions to identify applicable regulations/standards and assist with interpretation and compliance (e.g., ISO and IEC standards, REACH, ROHS, applicable sections of 21 CFR, regulatory agency guidance documents)
Effectively and accurately write and edit technical documents
Review and approve R&D, quality, preclinical and clinical documentation for submission filing
Evaluate proposed design, clinical and manufacturing changes for regulatory impact and approve changes in compliance with Regulatory requirements

Provide guidance to functional groups in the development of relevant data to complete a regulatory submission
In collaboration with cross-functional team members, compile, prepare, review and submit regulatory submissions to authorities in and outside the US (e.g., EU, Canada, Australia, Japan, etc.)
Interact and negotiate with regulatory authorities during the development and review process to ensure submission approvals
Effectively communicate application progress to internal stakeholders
Effectively communicate, prepare, and negotiate both internally with cross-functional teams and externally with various regulatory agencies.
Direct the process for preparation and maintaining annual licenses, registrations/listings for assigned geographies
Support product safety evaluation and reporting (e.g., MDR/Vigilance) as required by country regulation
Provide regulatory input for product recalls and recall communications
In collaboration with Regulatory management, develop, communicate, and build consensus for regulatory goals that are in alignment with the company goals and objectives
Review and approve advertising and promotional materials to ensure regulatory compliance
Evaluate, provide guidance and implement import/export requirements
Identify emerging issues and regularly communicate status
Provide other country specific regulatory support
Plan and conduct meetings, create project plans and timelines, and manage projects
Exercise good and ethical judgment within policies and regulations
Perform multiple tasks concurrently with accuracy
Other duties as assigned