About this job
- Industry: Pharmaceutical
- Area of expertise: Project Management & Services
- Location: Ontario
What is required?
- Hours per week: 40
- Education level: Professional Bachelor
About this role: Director, Regulatory Affairs
We are currently hiring a Director, Regulator Affairs for our client, a leading national patient support provider for specialty pharmaceuticals. The organization is known for delivering end-to-end support solutions to improve product access, increase supply chain efficiency and enhance patient care.
This is a full-time, permanent fully remote role. The Director, Regulatory Affairs reports directly to the Director, Regulatory Affairs to build and maintain a positive and productive liaison with internal and external customers in the regulatory consulting area. The Director, Regulatory Affairs is the primary contact for clients with responsibility for maintaining client relationships, including work on and oversight of client projects and services, quoting, and invoice reconciliation. Responsible for the overall management of key accounts and will support the new business process. Will lead several Regulatory initiatives and interact cross-functionally to support the team.
- Prepares client proposals and generating new business for TPIreg, including leading presentations to potential RA clients, and participating in multifunctional presentations
- Prioritize and manage multiple simultaneous projects to meet budget (including invoice review), timelines and client expectations; anticipate and resolve emerging issues
- Development and implementation of RA activities including assessments, strategies, submissions and agency interactions, applying expert knowledge in core area of regulatory practice (e.g., CMC, Medical Devices, CTAs, US etc.) and at least basic knowledge outside of core area
- Maintain target billables by obtaining new business
- Creates opportunities to build agency relationships by participating in professional activities such as offering industry training, conference presentations, publications, and webinars
- Leads client and agency interface, with responsibility for strengthening relationships and growing the business. Responsible for the quality of deliverables, by ensuring compliance with company and client review and approval processes; identifies and implements opportunities for process improvement
- Develop and maintain partnerships with senior decision-makers to build the business, resolve significant issues, and create opportunities
- Analyze data, the regulatory environment and business objectives to make and implement recommendations, using judgement to identify innovative solutions while managing uncertainty
- Lead and advise clients and cross-functional teams on agency interactions Leads decision-making and conflict resolution surrounding regulatory issues within cross-functional teams
- Proactively identifies, shares, and interprets regulatory intelligence
- Manage multiple simultaneous projects to ensure that they are on budget, meet timelines and client expectations.
- Engages in continuous learning activities to provide effective consulting services and be a sought-after resource.
- Develop and manage 0-2 regulatory direct reports at Manager level or below, as assigned. Including but not limited to assignment delegation, time and budget management, skill and knowledge development
- Travel as required
- Other related duties as assigned
- B.Sc. degree in life sciences (Pharmacology, Molecular Biology, Biology, Chemistry or Pharmacy) or Engineering.
- Advanced Degree in related field is preferred
- 10+ years of relevant experience in regulatory affairs or related functions in pharmaceutical/biologic/medical device development/ manufacturing. In-depth experience in a designated area of specialization (e.g., Medical devices, clinical trials, CMC) may be required
- Broad understanding of international regulations, processes, and issues in drug/biologics/medical device development. Includes sound knowledge of ICH, Health Canada, FDA, EMA, and other relevant guidelines with focus in area of specialization such as CMC, biologics, pharmaceuticals, Clinical Trials, OTC/NHPs medical devices, or FDA
- Regulatory Affairs Certification (RAC) and other certifications are an asset
- Prior consulting experience is preferred.
- In depth experience of successfully managing Health Authorities interactions on a regional basis
- In depth regulatory expertise in regulatory specialization required for the role, such as medical devices, CMC, or advertising/promotion
- Extensive experience and working knowledge of a wide range of regulatory submission types
- Superior project management skills to manage multiple concurrent projects within established timelines in a dynamic environment
- Advanced strategic planning and complex problem-solving skills to resolve complex issues with innovative solutions effectively and efficiently
- Demonstrated senior leadership abilities in a cross-functional, multi-disciplinary team environment
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Any questions remaining?
Your consultant, Angelina Brathwaite is happy to clarify anything about this vacancy. When reaching out, use the pub number:
Brunel Canada - Toronto