Senior Associate - Regulatory Affairs
New
J
JobgetherHealthcare
Based in United StatesFull-TimeSenior
Salary$83,974.90 – $113,613.10 USD per year
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Job Details
- Experience
- Master's degree; or bachelor's + 2+ years; or associate + 6+ years; or high school/GED + 8+ years
- Required Skills
- Project ManagementCompliance
Requirements
- Master’s degree required, or equivalent combination of education and regulatory experience.
- Bachelor’s degree with 2+ years of Regulatory Affairs experience.
- Associate degree with 6+ years of relevant experience.
- High school diploma/GED with 8+ years of Regulatory Affairs experience.
- Understanding of regulatory processes, documentation requirements, and compliance standards.
- Strong organizational skills with the ability to manage timelines, priorities, and multiple deliverables.
- Excellent written and verbal communication skills with the ability to collaborate effectively across teams.
- Ability to support meetings through agenda preparation, documentation, follow-up actions, and coordination.
- Detail-oriented mindset with strong problem-solving skills and the ability to work independently.
- Experience working in a regulated industry, scientific environment, or clinical setting is highly valued.
Responsibilities
- Support regulatory activities by assisting with the preparation, review, and submission of regulatory documents under the guidance of experienced regulatory leads.
- Maintain regulatory documentation, including product histories, agency communications, submission records, and archival systems.
- Provide support for regulatory filings such as annual reports, amendments, investigator packages, and other required documentation.
- Collaborate with cross-functional teams to coordinate regulatory deliverables and ensure compliance with submission requirements.
- Review regulatory plans and contribute input to operational activities supporting product development strategies.
- Support health authority interaction activities and assist with preparation of regulatory materials, briefing documents, and correspondence.
- Coordinate the collection, quality control, and organization of regulatory documents from internal teams, partners, and external vendors.
- Participate in regulatory strategy discussions and support execution of regulatory goals within assigned programs.
- Provide regulatory guidance and support to clinical, medical, commercial, and other internal stakeholders.
- Contribute to process improvement initiatives, development of regulatory standards, template creation, and operational efficiency improvements.
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