Our client, a manufacturing company located near Brantford, ON is looking for a Regulatory Affairs Specialist to join their team.
What you will do in this role:
- Develop and implement regulatory strategic plans for product registration and lifecycle management.
- Lead the preparation of regulatory submissions including New Drug Submissions (NDSs), Medical Devices, and ad hoc reports to regulatory bodies, and maintain the life cycle of currently marketed regulated products.
- Track registrations and effectively communicate with leadership team on a projects progress to ensure all critical timelines are met.
- Lead the preparation and review of responses of regulatory queries in relation to clinical efficacy and safety as needed.
- Lead interactions with Health Canada from pre-submission and throughout the submission review cycle to ensure prompt regulatory approval, optimal labelling, and implementation of local regulatory strategies.
- Collaborate with internal partners to ensure alignment of regulatory affairs strategy with business priorities, and to meet strategic business objectives and deadlines.
- Develop effective working relationships with business partners, clinical professionals, and federal/provincial authorities to support regulatory strategies as needed.
- Monitor regulatory changes and applicable regulatory requirements, identify impact of changes and/or regulations on operations and products and communicates changes across the organization
- Provide regulatory guidance and input to internal partners on messaging, labelling, SDS development and marketing materials.
- Maintain and establish product documentations, certificates of analysis and product specification documents. Maintain Regulatory documentation system, data, product Periodic safety Update report (PSUR), and status of API suppliers.
- Monitor company’s regulatory landscape, interpret changes, analyse gaps, and conduct impact assessment, and participate/lead implementation into new systems and/or processes.
- Actively contribute to improving critical departmental processes and to initiatives to enhance the internal work environment.
- Aid in achieving compliance with Domestic and International Regulatory Regimes (including but not limited to ISO 13485 specifications, GHTF Regulations, Canadian and American Medical device, Pharmaceutical, NHP etc. and GMP regulations).
What you will bring to the role:
- University degree at a Bachelor level or greater in Science or Pharmacy or related discipline (Quality Management)
- Certificate in Regulatory Affairs
- Ability to interact and negotiate with various governing authorities
- Understanding of Canadian/American/European laws and regulations as they pertain to drugs, medical devices, NHPs and cosmetics
- Strong computer knowledge and Office software skills – Microsoft Word, Excel, Outlook
- 5+ years working in a similar role (Canadian/International Regulatory Affairs)
- In-depth knowledge of Canadian, US, and international regulations for disinfectants, hand sanitizers and medical devices is a definite advantage
- Knowledge of various acts & regulations including HC, FDA, EPA, NNHPD, PMRA, CFIA, NSN (CEPA), and NHP
- Participated in internal and external regulatory audits
- Proficiency in MS Office Products or equivalent.
- Experience with web-based applications, particularly regulatory applications (e.g., eCTD software etc.)
What our client is offering:
- A competitive salary and full medical/health benefits for the employee and their family.
- The chance to join a growing company with a great work environment.
If you feel that this role would be a good fit for you, please submit your resume today in MS Word format – Don’t forget to include your accomplishments and achievements.
