
Senior Regulatory Affairs Manager
19 hours ago
A Senior Regulatory Specialist is needed to provide expertise in regulatory affairs to support our clients in the cosmetics and personal care sector.
This role involves ensuring compliance with regulatory agency regulations and interpretations, preparing responses to regulatory agencies' questions, and gathering information necessary for submissions.
The ideal candidate will have a strong background in regulatory affairs, excellent communication skills, and the ability to work effectively in a team environment.
Responsibilities:
- Ensure compliance with regulatory agency regulations and interpretations.
- Prepare responses to regulatory agencies' questions and other correspondence.
- Gather and assemble information necessary for submissions in accordance with regulations and relevant guidelines.
- Develop timelines for submissions under the direction of senior regulatory affairs staff.
- Provide solutions to complex problems requiring data analysis and evaluation of intangible variables.
- Offer regulatory advice to project teams and organize reporting schedules for new drug/medical device applications and renewals.
- Conduct global regulatory impact assessments for changes at manufacturing sites and ensure submission of relevant changes.
- Review and approve text drafts and artworks of labels, packaging, and instructions for use.
- Support Regulatory Affairs during audits.
What We Offer:
- Fulfilling a mid-senior level position
- A full-time employment opportunity
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