We are seeking a detail-oriented and experienced Regulatory Pharmacist to join our team. The ideal candidate will play a vital role in preparing, compiling, and maintaining regulatory documentation, including CTD dossiers, databases, and systems. This position ensures compliance with national and international regulatory requirements, coordinates with relevant authorities, and supports all regulatory submissions and activities.
Qualifications:
- Doctor of Pharmacy (Pharm-D) degree from a recognized institution.
- 1-2 years of experience in regulatory affairs in a pharmaceutical or nutraceutical company.
Requirements:
- Proven experience in regulatory affairs in the pharmaceutical industry.
- Knowledge of international regulatory authorities.
- Excellent communication and interpersonal skills.
- Detail-oriented with a focus on compliance.
- Familiarity with federal, state, and local regulatory requirements.
Key Responsibilities:
- Responsible for preparing, compiling, and maintaining CTD dossiers in compliance with national and international regulatory requirements to support timely regulatory submissions and approvals.
- Compile and maintain regulatory documentation databases/systems.
- Submit applications and reports to regulatory agencies.
- Respond to requests for information from regulatory bodies.
- Coordinate with operations departments for production compliance.
- Stay updated on relevant regulations affecting the company.
- Monitor regulatory changes and their impact on operations.
- Build and maintain relationships with regulatory agencies.
- Perform other related duties as assigned.
Job Type: Full-time
Work Location: In person
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