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Regulatory Affairs Specialist III

2 months ago

Skaneateles, New York, United States Equiliem Full time
Position Overview
Can be fully remote or hybrid.

Under general supervision, this role is responsible for the coordination and preparation of documents/packages for regulatory submissions. The incumbent will review and assess technical and scientific data and reports necessary for submission in support of the company's products.

Key Responsibilities
1. Track the status and progress of regulatory documentation.
2. Review, edit, and proofread regulatory documentation.
3. Assist in the preparation and review of labeling, Standard Operating Procedures (SOPs), and other departmental documents.
4. Compile regulatory documents for submission under supervision.
5. Actively participate as a team member in project teams as required.
6. Compile and prepare responses to inquiries from regulatory authorities.
7. Maintain regulatory files in a format consistent with requirements.
8. Stay informed about regulatory requirements and may be responsible for a specific product portfolio in the region.

Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. The following knowledge, skills, and abilities are required:
- Scientific knowledge.
- Strong written and verbal communication skills.
- Familiarity with regulations.
- Proficiency in technical systems (e.g., word processing, spreadsheets, databases, online research).
- Skills in proofreading and editing.
- Ability to contribute to multiple projects from a regulatory affairs perspective.
- Capability to multitask and prioritize effectively.

Education and Experience
A Bachelor's degree or equivalent in pharmacy or a related scientific discipline with 0-2 years of regulatory experience, preferably within a healthcare environment.

About Equiliem
Equiliem believes in empowering success. We cultivate relationships that connect people and employers in an inclusive and intelligent manner, allowing both to thrive. Leading companies across various sectors rely on us for their workforce solutions, including contract and direct hire staffing, Payrolling/EOR, Independent Contractor Compliance, and Managed Services.

For nearly 30 years, we have shaped our industry by continuously enhancing the candidate journey and client experience.

EEO Employer
Equiliem is an equal opportunity employer. We do not discriminate based on any characteristic protected by law.