Regulatory Affairs Specialist
1 week ago
About the Role:
We are seeking a skilled Regulatory Affairs Specialist to join our organization. The successful candidate will be responsible for planning and managing regulatory projects from start to finish, ensuring timely completion and meeting project milestones.
The ideal candidate will have a strong understanding of scientific data for regulatory submissions and be proficient in Microsoft Office. Experience with legal contract management is an advantage.
Key Responsibilities:
- Plan and manage regulatory projects, including preparation of regulatory documents and specification sheets for product registration in multiple markets.
- Oversee operational activities, including regulatory assessments, training, PIP registrations, license management, and document control.
- Gather and consolidate technical and management reports for regulatory submissions.
- Review marketing and technical materials for regulatory compliance.
- Support due diligence on contracts and materials to protect intellectual property.
- Provide administrative support for PIP meetings, setting agendas, taking minutes, and following up with stakeholders.
- Track project progress and manage document reviews through internal systems.
- Support team operations with various administrative and ad-hoc tasks.
Qualifications:
- Bachelor's degree in a Science-related field (e.g., Biochemistry, Microbiology, Food Science, Pharmaceutical Science, etc.).
- At least 2 years of project management experience preferred; PMP certification is a plus.
- Strong time management skills and ability to handle multiple projects simultaneously.
This is a fantastic opportunity for a motivated and detail-oriented individual to take on a challenging role in the healthcare and life science industry.
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