
Regulatory Affairs Specialist
14 hours ago
An experienced professional with advanced knowledge and skills in managing complex regulatory projects, writing technical documents, and establishing relationships with clients.
Key Responsibilities:- Lead regulatory teams on complex projects, including technical writing and project management.
- Write regulatory and technical documents with minimal review by senior staff.
- Establish relationships with clients, presenting lessons learned and resolving issues.
- Provide guidance to junior colleagues, including feedback on document quality and assisting in their training and development.
- Presentation of regulatory deliverables to clients at bid defense meetings.
- Development of new regulatory standard operating procedures and proposal of revisions or acting as a reviewer.
- Bachelor's Degree in Life Sciences or related field (or Master's Degree).
- At least 8 years of relevant experience.
- Good understanding of Research and Development process, Chemistry, Manufacturing, Controls, Preclinical and Clinical laws and related guidelines.
- Specific regulatory or technical expertise.
- Knowledge of managing regulatory projects, project deliverables, and time-bound manner.
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