Director of Regulatory
2001-30000
Other
What are you going to do
Essential skills and knowledge
- Responsible for preparing client proposals and generating new business, 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
- Responsible for 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 the 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 in order 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
Essential skills and knowledge
- BSc. degree in life sciences (Pharmacology, Molecular Biology, Biology, Chemistry or Pharmacy) or Engineering.
- Advanced Degree in related field is preferred
- 12+ 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
- Prior consulting experience is preferred.
- 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.
- In depth experience of successfully managing Health Authorities interactions on a regional basis
- In depth regulatory expertise in the area of 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 in a dynamic environment
- Advanced strategic planning and complex problem-solving skills to resolve complex issues
JOB SUMMARY
Director of Regulatory