Regulatory specialist
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Apply Now Application ends in 15d 23h 53min
Job Detail
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Offered Salary 0
Job Description
Qualifications
- Bachelor’s degree in a relevant scientific discipline
- 3-5 years experience in RA; relevant industry experience may be considered
- Ability to work independently with minimal supervision on multiple projects simultaneously
- Understanding of drug development and regulatory requirements (standards, quality, timeliness)
- Organizational and planning ability
- Strong attention to detail and quality
- Good interpersonal and communication skills
- Ability to manage and prioritize a variety of project tasks
- Experience working with interdepartmental project teams
Benefits
- We offer a comprehensive and competitive benefit plan which includes market-competitive salaries, an annual bonus program, education assistance, retirement plan with employer match, stock options at all levels, summer hours and more!
Responsibilities
- You will provide support across all of Regulatory including Operations, Strategy and CMC
- This role will provide project management of multiple Regulatory workstreams
- This role will also act as a liaison between Regulatory and Clinical for support of all programs
- Coordinate and prepare regulatory submissions in collaboration with regulatory lead(s)
- Provide and maintain IND / CTA documentation support and manage timelines for submissions
- Work with other departments and communicate when documents are needed for regulatory submission
- Supports regulatory departmental activities as needed, including the authoring and reviewing of regulatory SOPs, work instructions, and templates
- Interact with colleagues in other departments, R&D functions and Regulatory Affairs functions to deliver high quality dossiers and documents in accordance with business priorities
- Working closely with regulatory leads or regional experts (EU, Japan), assist with implementation and management of ex-US activities and dossiers
- Author documents to support country specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents
- Assist with archiving of documents within the Veeva document management system
- Stay abreast of regulatory guidance and changes in regulatory climate
- Provide additional support as needed for team communications on planning and logistics for health authority meetings and preparation of minutes
Apply Now
Application ends in 15d 23h 53min