Regulatory Affairs Professional
3 weeks ago
Are you looking for a challenging role in regulatory affairs?
We are currently recruiting for a Regulatory Affairs Specialist to join our team at Kenvue.
Key Responsibilities
- Coordinate and compile new drug applications, cosmetics, medical devices, food supplements, or similar products for regulatory agencies within their geographical and/or brand area of responsibility.
- Collect and evaluate information on regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations.
- Prepare and submit regulatory submissions according to applicable regulatory requirements and guidelines.
- Monitor the progress of the regulatory authority review process through appropriate communication with the Health Authority, seeking opportunities to expedite regulatory approvals where possible.
- Prioritize, plan, and monitor allocated projects against defined timelines.
- Develop and maintain a thorough understanding of the regulatory environment and supporting data requirements.
- Ensure that all assigned products comply with local regulatory and quality system requirements.
- Review and approve promotional materials for assigned local Kenvue products.
- Initiate, review, and approve new or revised product artworks in collaboration with Cluster Artwork Coordinator.
- Assist in ensuring that the enterprise Regulatory systems are accurate and fully maintained.
- Identify and initiate local process improvement opportunities and manage changes as required.
- Assist in the preparation for internal and external audits and inspections in collaboration with others.
Requirements
- Relevant Bachelor's degree or higher.
- 4+ years of relevant regulatory experience.
- Excellent communication skills, with the ability to articulate and express concepts clearly both verbally and in writing, particularly when simplifying complex regulatory or technical issues.
- Good interpersonal skills; able to build effective personal networks internally and externally.
- Collaborative with a strong sense of ownership, willing to be held accountable and be rewarded for delivering results.
- Strong organizational and time management skills with an ability to work under pressure.
- Able to work effectively in a multi-cultural, highly matrixed organization.
- Proficiency in English.
What's In It For You
- Competitive benefit package.
- Paid company holidays, paid vacation, volunteer time, and more.
- Learning and development opportunities.
- Employee resource groups.
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