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Posted: 07-Sep-23
Location: Mississauga, Ontario, Canada
Type: Full Time
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Required Education:
Additional Information:
Internal Number: Regulatory Affairs
Intrinsik is a North American consulting firm focusing on the toxicology and regulatory challenges associated with the development of new products (pharmaceuticals, biologics, natural health products and cosmetics). We are continuing to grow, and always welcome candidates with strong scientific skills, creativity and enthusiasm to join our team. Intrinsik has an opening for a Regulatory Affairs Associate. This is a hybrid position at any of the following locations:
- Mississauga, Ontario, Canada
- Montreal, Quebec, Canada
- Raleigh, North Caroline, USA
This position involves providing a full range of publishing and document management support to the Regulatory Affairs Submission Coordination Unit and the Regulatory Affairs Managers, including preparation of submissions for both U.S. and Canadian markets. This position may also involve preparation of regulatory submissions (CTA, IND, NDS), including authoring of CTD Module 2.3/3 documents from source data. The successful candidate will have a broad base of regulatory experience, including preparation and maintenance of Clinical Trial Applications and New Drug Submissions. Specialization in authoring of Chemistry, Manufacturing and Controls (CMC) documentation for regulatory submissions will be a distinct asset.
We aim to offer our employees an environment that encourages professionalism, creativity, independence and continual learning. The assets of any knowledge-based company are its people, and we believe strongly in investing in those assets by offering training and mentoring to our employees.
Responsibilities include:
- Provides publishing, word processing and document management activities for the preparation of all regulatory submissions in paper and electronic formats for both U.S. and Canadian markets.
- Manages multiple submissions to ensure FDA/Health Canada submission deadlines are met.
- Inputs cross-references and annotations including hyperlinks when appropriate.
- Ensures compliance with FDA/Health Canada requirements (submission structure, formatting compliance with guidelines and policies).
- Builds relationships with local/global contacts to facilitate submission efforts.
- Critical assessment of documentation, including clinical trial protocols, Investigator’s Brochures, CMC data and documents.
- Preparation of CTD Module 1 documents, and authoring of Module 2.3/3 documents from source data.
- Interpretation of regulatory requirements and guidance.
Systems/Other Responsibilities:
- Lead user of many RA systems, identifying business/user requirements, testing and participating in the completion of appropriate computer systems documentation.
- Performs assigned tasks associated with document and regulatory fee management.
- Responsible for maintenance activities on behalf of RA such as custodian or administrator function, and providing access control for RA systems.
- Reviews projects to ensure compliance with applicable FDA/Health Canada and Industry codes and guidelines in alignment with client needs.
Qualifications Required:
- Minimum BSc in Life Sciences.
- Postgraduate Certificate in Pharmaceutical Regulatory Affairs is an asset.
- Understanding of the regulatory process for drug development.
- Strong computer expertise including extensive word processing experience; ability to quickly adapt to new technology.
- Familiarity with specialized publishing software applications and document management systems is an asset.
- Specific knowledge about regulatory affairs and the drug development process is an asset.
- Understanding of the regulatory process for drug development.
- Good working knowledge of current U.S. and Canadian regulations, guidance and policies.
- Prior experience with electronic submissions and strong computer technical skills are an advantage.
