Description:
The Regulatory Affairs Manager must possess leadership thinking, a business-minded approach, and the ability to field new regulatory projects. This position will play a pivotal role in ensuring the timely approval and regulatory compliance of pharmaceutical products, with a particular focus on generic submissions. Leading a team of associates, the candidate will also participate in various regulatory projects and must have a strong scientific background, an in-depth understanding of the pharmaceutical industry, including chemistry manufacturing controls (CMC), bioequivalence study requirements and mastery of applicable Canadian regulations (pharmaceuticals, NHP, medical devices, biosimilars). The candidate must be highly organized, capable of handling multiple priorities and projects, and have the ability to adapt to changing priorities with minimal supervision.
Specific Responsibilities:
- Supervise associates, providing coaching, mentoring, and reviewing submissions prepared by junior associates. Mentor new hires to facilitate their integration into the regulatory affairs team.
- Assume responsibility for the registration of new pharmaceutical products as well as the maintenance of regulatory compliance for approved products during the post-marketing phase.
- Prepare submissions (NDS, SNDS, ANDS, SANDS, Notifiable Changes submissions, and annual notifications) for brand and generic prescription drugs, biosimilars, clinical trial applications, master files) with accuracy. This includes critically evaluating scientific data (chemistry/manufacturing, clinical, and pre-clinical) and labeling to ensure successful and timely product registrations.
- Prepare applications for natural health products and medical devices to obtain optimal products approvals.
- Assemble and compile regulatory files in eCTD format and publish them using DocuBridge.
- Ensure that scientific data supporting submissions and daily regulatory activities comply with Canadian regulations, guidelines, and policies to address any identified gaps.
- Participate in the development and implementation of regulatory strategies, apply strategic and analytical thinking to lead projects, offer regulatory support, and provide advice to a diverse range of clients.
- Build strong client relationships through effective communication and collaboration.
- Field new projects from prospective clients and proactively seek opportunities for business growth.
Required Qualifications:
- B.Sc./M.Sc. degree in Biological/Life Sciences/Bioengineering (Pharmacology, Molecular Biology, Biology, Chemistry), or related fields.
- A minimum of 8 years of direct Canadian Regulatory Affairs experience.
- Hands on experience with preparing regulatory submissions for brand and generic prescription drugs, biosimilars within Canada.
- Advanced knowledge of bioequivalence/bioavailability study requirements.
- Experience working with small molecules across various dosage forms (solid oral, injectables, topicals, etc.).
- A strong background in Chemistry and Manufacturing Controls (CMC).
- Experience with eCTD knowledge and application.
- Advanced knowledge and application of Health Canada regulations.
- Clear and effective communication skills, both oral and written.
- Excellent attention to detail and exceptional organizational abilities.
- Resourceful, energetic, and self-motivated.
- Demonstrated sense of urgency, results-oriented, and performance-driven.
- Autonomy and strong leadership abilities.
- Ability to manage multiple projects concurrently while overseeing a team.
- Proven ability to meet tight deadlines and work effectively under pressure.
- Flexibility and adaptability in response to change
- Sound judgment in applying regulatory requirements
- Diplomacy in establishing and maintaining interpersonal relationships.
- Strong working knowledge of computer applications (e.g. MS Word, MS Excel, MS PowerPoint, MS Outlook, Adobe Acrobat).