Lead Regulatory Affairs Specialist (Remote)

Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally. In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area.

Job Description

Position Overview: RA project leader is responsible for all RA tasks of own modality without detailed supervision by the direct manager. As a project leader, lead RA members to submit in time as necessary providing guidance from an experienced professional standpoint. Report to direct manager or to core-team co-workers about submission projects status when it’s requested. This role involves working closely with healthcare regulatory bodies and industry association and requires an in-depth understanding of key business drivers to accomplish work effectively.

Key Responsibilities

• Provides regulatory input for product development to ensure compliance to regulatory requirements for target markets.
• Develops regulatory strategies to help guide regulatory submission pathways, taking into consideration regulatory, product claims and country regulatory dependencies to ensure optimized sequencing for submissions.
• Works with a cross functional team to prepare and submit regulatory submissions to regulatory authorities for the purpose of obtaining authorization for market launch.
• Assesses changes in existing products to and determines the need for new /revise licenses or registrations.
• Develops plan for timely submission of renewal registrations for applicable countries per business plan, to ensure continued product supply in those countries.
• Reviews and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements.
• Contributes to writing and editing technical documents.
• Assesses adverse events through approved license dossier to support Safety Management Team.
• Understands and applies regulatory requirements and their impacts for submissions. (Monitor new/revised requirements and investigate the impact to Japan registration. Triage entry and to be Subject Matter Expert as required.
• Researches, analyzes, integrates and organizes background information from diverse sources for regulatory submissions (Access to multiple sources to get necessary information with clear objectives and strategies.)
• Ensures compliance with pre- and post-market product approval requirements. (Lead communication with authorities as necessary and take appropriate action without detailed supervision of direct manager.)
• Supports regulatory inspections as required. (Support direct manager to have internal and external audit.)
• Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager.

Experience Requirements

• A min. of 5 years experiences to handle product registration project as an independent Regulatory Affairs professional.
• QA/Safety Management experience is also preferred.
• Advanced level Japanese language skill to understand regulatory documents and to generate high quality submission package.
• Business level English (writing, reading, speaking) is required.
• Proven interpersonal skills and ability to communicate effectively with regulators, colleagues and business partners.
• Professional judgment and ability to operate with some autonomy, seeking senior guidance when necessary.
• Flexibility to adapt to different & unique process and cultures in new working environment. Especially, sharing mind, coaching skills and motivation to contribute for team, are preferred.

Required Behaviors

• Servant Leadership:

• Prioritize team and organizational needs.
• Foster a supportive and collaborative environment.
• Actively listen and provide constructive feedback.
• Mentor colleagues and lead by example.

• Embrace challenges and view them as growth opportunities.
• Learn from setbacks and seek continuous development.
• Encourage innovation and creative problem-solving.

• Deliver value efficiently and eliminate waste.
• Continuously improve operations using data-driven decisions.
• Promote accountability and responsibility.

• Value diverse perspectives and create an inclusive environment.
• Seek input from diverse voices and challenge biases.
• Foster equity and inclusion.

• Encourage initiative and ownership.
• Support risk-taking and experimentation.
• Provide resources for innovative ideas and recognize efforts.

This role is ideal for an individual contributor or a RA project leader who is considering to become a people manager in near future with a strong background in regulatory affairs, who can provide strategic direction and ensure compliance with healthcare industry standards while embodying our cultural operating principles. If you have the expertise and are ready to make an impact, we encourage you to apply.

Additional Information

Relocation Assistance Provided: No