Regulatory Affairs Specialist
4 weeks ago
At Kenvue, we are seeking a highly skilled Regulatory Affairs Specialist to join our team. This role is responsible for ensuring compliance with regulatory requirements for consumer healthcare products within their geographical and brand area of responsibility.
Key Responsibilities:
- Coordinate and compile submissions for new drug applications, cosmetics, medical devices, and food supplements to regulatory agencies.
- Collect and evaluate information on regulatory requirements for quality, preclinical, and clinical data.
- Prepare and submit regulatory submissions according to applicable regulations and guidelines.
- Monitor the progress of regulatory authority review processes and communicate with Health Authorities to expedite approvals.
- Prioritize, plan, and monitor allocated projects against defined timelines.
- Develop and maintain a thorough understanding of the regulatory environment and supporting data requirements.
Requirements:
- Relevant Bachelor's Degree or higher.
- 4+ years of relevant regulatory experience.
- Excellent communication and interpersonal skills.
- Strong organizational and time management skills.
- Proficiency in English.
What We Offer:
- Competitive benefit package.
- Paid company holidays, paid vacation, and volunteer time.
- Learning and development opportunities.
- Employee resource groups.
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