The Regulatory Affairs Manager provides a support role to the IDEM Business Unit Manufacturing Site and key project activities. The Regulatory Affairs Manager reports to the Associate Director Regulatory Affairs (manufacturing sites), IDEM. The role is based in Chiba, Japan.
This position applies regulatory expertise to guide cross-functional partners and demonstrates strategic thinking and creativity in support of key business programs as a legal manufacturing site. This site will act as the legal manufacturing site for products manufactured in Japan. For some product/country couples, this role will be an internal supplier to an EU based LM..
- Develop and implement regulatory strategies that appropriately assess regulatory impact and ensure earliest possible introduction of product(s) or postmarket change management activities into global markets.
- Oversee processes involved with obtaining and maintaining product release authorization and release of product to specified geographies.
- Interface directly with various regulatory agencies, as required, to facilitate the review and approval of regulatory applications.
- Provide technical leadership for site certifications and quality management system audits.
- Coordinates with cross functional teams including but not limited to: IVDR teams, EU Regulatory, International Regulatory, Marketing / PLC, Supply Planning, Customer Service, etc. to ensure all internal and external requirements are met prior to product release.
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Provides input and comment on regulations and standards which may affect division products
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices; build productive internal/external working relationships.
- Apply specialized knowledge to coordinate day-to-day work.
- Collaborate with cross-functional global teams
- Analyze information to select appropriate options from defined alternatives.
- Apply experience and judgment to make decisions or resolve issues within defined options or standard protocols.
- Carries out duties in compliance with established business policies.
- Accountable for budgets, schedules, and ensuring compliance to divisional and corporate policies as required.
- Develop and maintain strong and effective relations with internal/external personnel.
- Other duties as assigned, according to the changing needs of the business.
- Independently gather resources and information needed to complete projects.
- Minimum of a Bachelor’s Degree (BA/BS) from an accredited University
- Minimum of 6 years of experience in a GMP / Biotech / Pharma / Medical Device/ IVD/ Regulated Industry.
- Strong written and verbal communication skills
- Demonstrated success in the GMP / Biotech / Pharma / Regulated Industry.
- Ability to adapt quickly and effectively to shifting priorities.
- Very strong attention to detail
- Must be coachable and must follow written and verbal direction
- Must be able to productively generate quality documentation to meet Program timelines
- Flexible scheduling (if needed and advance notice is given)
- Strong skills in Microsoft Office, especially in Word, Excel, and PowerPoint
- General knowledge of Quality/Regulatory requirements in a medical device/ pharma/ biotech industry
- Adaptability, Innovation, Initiative, Teamwork, Quality of Work, Commitment