Senior Associate Regulatory Affairs – Woburn, MA
The Sr. Associate, Regulatory Affairs participates in ensuring that all relevant requirements are met for regulatory submissions 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 Investigational New Drug (IND), Clinical Trial Application (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
- A or B.S. degree in an appropriate scientific or related field
Experience and skill requirement:
- At least 3 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 International Conference of Harmonization (ICH) Guidelines regarding GMP/GCP, ICH Guidelines for Electronic Common Technical Document (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.
EEO & Employment Eligibility:
Replimune is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, ancestry origin, disability or veteran status. Replimune also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.
Replimune, Inc. does not accept agency resumes unless contacted directly by internal Replimune Talent Acquisition.
Please do not forward resumes to our careers site, employees or any other company location of Replimune. Replimune will not be responsible for any fees related to unsolicited resumes.