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Senior Associate, Regulatory Affairs
Department: Regulatory Affairs
Reports to: Director, Regulatory Affairs
Location: Office US-based
Summary of job description:
The Sr. Associate, Regulatory Affairs participates in ensuring that all relevant requirements are met for regulatory submissions (including IND, CTA, BLA, etc.) to the FDA and other regulatory agencies. Provides support in the further development, implementation and maintenance of Regulatory Affairs systems.
- Participates in the preparation of documentation packages for regulatory submissions (including IND, CTA, etc.) to the FDA and other regulatory agencies.
- Formats, edits, coordinates and reviews regulatory documentation for inclusion in INDs, CTAs, and other worldwide submissions.
- Compiles documentation for submissions to FDA and foreign regulatory agencies.
- Maintains regulatory documentation including submissions to and correspondence with each governing authority.
- Reviews clinical and technical documentation for regulatory compliance.
- Interfaces with other departments (Quality Assurance, Clinical Operations, Operations, CMC, etc.) to coordinate collection of information for implementation in regulatory submissions.
- Performs other appropriate administrative duties, such as preparing correspondence (records of contact), filing, quality management system support, where necessary.
- Maintains chronological and operational trackers as needed.
- Responsible for maintenance of regulatory affairs product files to support compliance
B.A or B.S. degree in an appropriate scientific or other related field
Experience and skill requirements:
- Three to six plus years’ experience in Pharmaceutical/Biotech industry, to include a minimum of 2 years’ experience in a Regulatory Affairs/Regulatory Operations capacity.
- Knowledge and practical understanding of ICH Guidelines regarding GMP/GCP, ICH Guidelines for CTD/eCTD and CDER requirements for the drug approval process.
- Previous participation in preparing regulatory submissions (IND, CTA, BLA, etc.) to the FDA and EU Regulatory Authorities.
- Solid understanding of the e-CTD specifications for electronic submissions
- Strong technical writing ability and previous experience in documentation preparation/publishing using Adobe Acrobat, preferred.
- MS Office Expertise: Outlook, Word, Excel, PowerPoint, Project, Visio. Also EndNote and Adobe Professional is preferred.
- Strong interpersonal, organizational, and time management skills.
- Ability to handle matters of strict confidentiality and sensitivity.
- Strong attention to detail, organized, and dependable.