for the Regulatory Analyst I position
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Regulatory Analyst I
Coventry - Rhodes Technologies
This position will perform responsibilities to support the Regulatory Affairs department.
- Manage regulatory affairs drug product projects through entire lifecycle from initiation through commercialization.
- Create and review drug product labeling components for both NDAs and ANDAs.
- Compose, review, and submit to the FDA original INDs, NDAs, ANDAs, supplements, amendments, annual reports, and periodic adverse event reports in both paper and electronic CTD format. Review all chemistry, manufacturing, and controls (CMC) documentation related to submissions.
- Serve as regulatory representative on cross-functional teams supporting products throughout varied stages of development and commercialization. Ensure regulatory and cross-functional project strategies and submission timelines are in alignment.
- Develop and track regulatory project timelines that incorporate all submission requirements including CMC, clinical, and labeling functions.
- Communicate regulatory requirements and expectations to various contract organizations, including travel for on-site meetings as necessary.
- Serve as company representative on industry groups relevant to current or future products. As needed, travel to face-to-face meetings and communicate decision points and outcomes to senior management.
- Evaluate proposed changes to approved products for potential regulatory impact. Gather required data as needed to defend regulatory filing strategy.
- Contact FDA for review status updates of pending applications and supplements.
- Author and review departmental SOPs, as well as any additional SOPs that may impact regulatory affairs.
- Monitor various websites and publications to gather regulatory intelligence on proposed product pipeline and any associated information.
- Perform due diligence audits of applications proposed for transfer from external partners. Review all documentation submitted throughout the lifecycle of the application and request any additional information prior to authorization of the transfer.
Education and Experience
- Experience filing electronic CTD submissions in the US.
- Experience with regulatory timeline development and tracking.
- Excellent verbal and written communication skills.
- Availability and willingness to travel as necessary.
- BS in science or related field with 3 or more years of applicable US Regulatory Affairs experience.
- US Regulatory Affairs Professional Certification is desirable.
- Advanced degree preferred
Necessary Knowledge, Skills, and Abilities
The problems and situations faced will often be complex and will vary depending on the project. Clear and concise communication with internal and external partners in a timely manner is essential to keeping projects on track. The ability to recognize and establish priorities of competing projects is critical.
Prepare and submit high quality INDs, NDAs, ANDAs for assigned products in a timely manner. Attend Project Team meetings and provide regulatory input during the development phase of assigned projects.
Supervisory Responsibilities (if Applicable)
The Regulatory Affairs Analyst II will have freedom to act independently in managing Regulatory Affairs projects. This includes developing and implementing goals, policies, and procedures for the regulatory affairs group as deemed necessary.
The productivity and accuracy required of this employee is essential to the on-time registration of new products as well as the continued compliance of marketed products. Errors and missed deadlines could result in delays of approvals for new products or regulatory action due to failure to comply with the Code of Federal Regulations for established products. This position requires the employee to work closely with multiple contract organizations, outside regulatory consultants, various internal departments, contacts from associated companies, and the FDA directly for assigned projects. Clear, concise communication in verbal and written forms is essential as confusion or ambiguity can result in delays of product availability and(or) drug product approval.
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