The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
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 requirement:
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.
Additional Salary Information: Base + Bonus + Stock
Internal Number: 1111
Cancer is one of the most difficult diseases to treat. It is constantly changing, requiring new and more sophisticated therapies. Replimune is pioneering a new generation of cancer treatments called oncolytic immunotherapies. Oncolytic immunotherapy is an emerging class of cancer therapeutics which exploit the ability of viruses to selectively replicate in and kill tumors, while at the same time inducing a potent, patient-specific, anti-tumor immune response. Oncolytic viruses have the unique ability to generate an autologous immune response to the patient’s particular complement of tumor antigens, including neoantigens, with a truly off-the-shelf approach. While clear single agent clinical activity has been achieved with oncolytic immunotherapy, it is anticipated that enhanced efficacy may be seen in combination with other cancer therapies, including immune checkpoint blockade.