Job Title: Regulatory Affairs Associate Jr
Contract Length: 1 yr
Number of Openings: 1
- Provide registration support to ensure timely launch of changes in products registered globally.
- Ensure product launch timelines are met.
- Ensure completeness of product registration dossiers according to product regulatory classification.
- Provide full support to reporting manager in terms of content review, document fulfillment check, document preparation, filing support and archival of regulatory records.
- Prepare risk analysis and mitigation strategies of any new/upcoming requirements for business.
- Compile and review regulatory submissions for timely registration of changes in products of entire range of on-market products for AMD.
- Ensure product regulatory launch plan is strictly met.
- Sensitize reporting manager with inputs on possible factors which may impact the regulatory launch plan timeline of new product line for AMD.
- Provide timely inputs to reporting manager in modifying product launch timeline with adequate time to implement same without any financial/resource constraints.
- Identify upcoming/evolving regulatory requirements for new IVD product launch.
- Work with reporting manager to maintain good contact and ensure timely follow-up with regulatory agencies.
- Determine the scope of information/documentation necessary to file new registration applications and post-approval changes according to existing checklists to regulatory agencies.
- Review product labeling material for compliance with applicable regulations and standards.
- Ensure regulatory project deadlines and performance standards are established and met.
- Work on instructions from reporting manager towards timely submission of products and project tracking.
- Daily follow-up on availability of documents and work on documentation availability timeline to ensure minimal impact on regulatory launch plan for new range of products.
- Draft processes for new regulatory requirements towards effective implementation.
Minimum Skill, Education, Experience
• Bachelor's degree in life sciences or pharmacy (Biochemistry, Biotechnology, Microbiology, Immunology, Medical technology, pharmacy, Pharmacology) is preferred. Masters in above field will be preferred.
• 2 years at minimum with a regulated industry. Strong knowledge of IVD or Medical device regulatory affairs
• Knowledge on requirements of Global product registration.
- Project Manager Skills
- Product knowledge on In-vitro diagnostics products will be preferred.
Joule Clinical (formerly Syneos Health Clinical Staffing)Joule, a SystemOne division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.