Regulatory Compliance Specialist
2 weeks ago
We are seeking a Regulatory Compliance Specialist to join our team. This role is essential in ensuring that our products meet the necessary regulatory standards and guidelines.
Duration:
- 3+ Months
Key Responsibilities:
Under general supervision, the incumbent will be responsible for:
- Coordinating and preparing documentation for regulatory submissions.
- Reviewing and assessing technical and scientific data required for compliance.
- Tracking the status and progress of regulatory documentation.
- Editing and proofreading regulatory documents to ensure accuracy.
- Assisting in the preparation and review of labeling, standard operating procedures (SOPs), and other departmental documents.
- Compiling regulatory documents for submission under supervision.
- Participating as an active member of project teams as needed.
- Preparing responses to inquiries from regulatory authorities.
- Maintaining regulatory files in accordance with established requirements.
- Staying informed about regulatory changes and requirements.
Qualifications:
To be successful in this role, candidates should possess:
- A Bachelor's degree or equivalent in pharmacy or a related scientific field.
- A minimum of 7 years of regulatory experience, preferably in a healthcare setting.
- Strong scientific knowledge and effective written and verbal communication skills.
- Familiarity with regulatory standards and technical systems (e.g., word processing, spreadsheets, databases).
- Excellent proofreading and editing abilities.
- The capacity to manage multiple projects from a regulatory perspective.
- Strong prioritization and multitasking skills.
About Select Source International
Select Source International (SSI) is a consulting firm specializing in IT, Health Care, and Engineering Services. Established in 1998, SSI has built a reputation for delivering exceptional services to a diverse range of clients, including Fortune 500 companies and mid-sized enterprises.
Our consultants are dedicated to providing high-quality solutions that meet the needs of our clients and enhance their operational effectiveness.
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