Director/consultant Regulatory Affairs
1 month ago
**Job Details**:
**Primary Duties and Responsibilities**:
- Responsible for preparing 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
- 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 Innomar 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 unertainty.
- 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
- Travel as required
- Other related duties as assigned
**Experience and Educational Requirements**:
- B.Sc. 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
- Regulatory Affairs Certification (RAC) and other certifications are an asset
- Prior consulting experience is preferred.
- Leadership skills required
**Minimum Skills, Knowledge and Ability Requirements**:
- 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 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.
- Ability to drive results in a team environment
- Strong business and financial acumen
- Strong analytical and mathematical skills
- Ability to communicate effectively both orally and in writing;
- Excellent presentation skills
- Excellent leadership and interpersonal skills
- Effective organizational skills; attention to detail
- Ability to consistently meet deadline
- Knowledge of computers, to operative effectively with Adobe Acrobat, Microsoft Word, Excel spreadsheets, and Microsoft Outlook Ability to develop professional networks that will drive business development and regulatory intelligence
**What Cencora offers**:
We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid
-
Director/Consultant, Regulatory Affairs
4 weeks ago
Oakville, Canada AmerisourceBergen Full timep>Director/Consultant Regulatory AffairsApply locationsOakville, ON Remote, BC Remote, AB Remote, MB Remote, NBTime type: Full timePosted on: Posted 3 Days AgoJob requisition id: R2424563Our team members are at the heart of everything we do. If you want to make a difference at the center of health, come join our innovative company and help us improve the...
-
Regulatory Affairs Lead
1 month ago
Oakville, Ontario, Canada AmerisourceBergen Full timeAbout the RoleWe are seeking an experienced Regulatory Affairs professional to lead our team in developing and implementing regulatory strategies for pharmaceutical, biologic, and medical device development. The successful candidate will have a proven track record of managing multiple projects simultaneously, prioritizing tasks, and meeting deadlines.Key...
-
Manager, Regulatory Affairs
6 days ago
Oakville, Canada AmerisourceBergen Full time- What you will be doing Why choose Innomar Strategies_ - _ “Remote-First” culture - flexible opportunities to work from home!_ - _ Competitive Total Rewards Package:_ - _ Base salary + bonus programs_ - _ RRSP matching_ - _ Employee Share Purchase Plan_ - _ Flexible benefits program (in effect on day one), including:_ - _ Healthcare Spending Account_ -...
-
Oakville, Ontario, Canada AmerisourceBergen Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to lead our regulatory affairs team and provide strategic guidance on regulatory compliance, strategy development, and implementation. This is an exciting opportunity to join our innovative company and contribute to improving the lives of people and animals everywhere.About UsCencora...
-
Regulatory Affairs Specialist
5 days ago
Oakville, Canada Natus Medical Incorporated Full time**Regulatory Affairs Specialist** **Welcome to Natus Medical Incorporated**: We’re the leading manufacturer of medical devices and software for a range of specialities, including new-born care, neurology, sleep, hearing and balance markets. Our mission is to improve patient outcomes in target markets through innovative screening, diagnostic and treatment...
-
Regulatory Affairs and Quality Assurance Expert
4 weeks ago
Oakville, Ontario, Canada Xediton Pharmaceuticals Inc Full timeAbout Xediton Pharmaceuticals IncXediton Pharmaceuticals Inc is a privately-held pharmaceutical company dedicated to meeting the needs of patients, physicians, and partners.We are located in Oakville, Ontario, where we strive to make a positive impact on people's lives through innovative solutions.Job Title: Regulatory Affairs and Quality Assurance...
-
Oakville, Ontario, Canada Xediton Pharmaceuticals Inc Full timeXediton Pharmaceuticals Inc is a privately-held pharmaceutical company committed to meeting the needs of patients, physicians, and partners.We are seeking a highly motivated Regulatory Affairs and Quality Assurance Associate to support our team in Oakville, Ontario.**Job Summary:**The successful candidate will be responsible for supporting drug, medical...
-
Oakville, Canada Xediton Pharmaceuticals Inc Full timeCompany Description: Xediton is a privately-held pharmaceutical company with a focus on meeting the needs of patients, physicians, and partners. We are located in Oakville, Ontario. For more information, please visit REGULATORY AFFAIRS and QUALITY ASSURANCE ASSOCIATE Job Description & Key responsibilities The Regulatory Affairs Associate will...
-
Oakville, Ontario, Canada Xediton Pharmaceuticals Inc Full timeXediton Pharmaceuticals Inc is a dynamic privately-held pharmaceutical company headquartered in Oakville, Ontario. We are committed to meeting the needs of patients, physicians, and partners by providing high-quality products and services.Job SummaryWe are seeking an experienced Regulatory Affairs and Quality Assurance Associate to join our team. As a key...
-
Oakville, Canada Xediton Pharmaceuticals Inc Full timeCompany Description:Xediton is a privately-held pharmaceutical company with a focus on meeting the needs of patients, physicians, and partners. We are located in Oakville, Ontario. For more information, please visit www.xediton.comREGULATORY AFFAIRS and QUALITY ASSURANCE ASSOCIATE Job Description & Key responsibilities The Regulatory Affairs Associate...
-
Oakville, Canada Xediton Pharmaceuticals Inc Full timeCompany Description:Xediton is a privately-held pharmaceutical company with a focus on meeting the needs of patients, physicians, and partners. We are located in Oakville, Ontario. For more information, please visit www.xediton.comREGULATORY AFFAIRS and QUALITY ASSURANCE ASSOCIATE Job Description & Key responsibilities The Regulatory Affairs Associate...
-
Oakville, Canada Xediton Pharmaceuticals Inc Full timeCompany Description:Xediton is a privately-held pharmaceutical company with a focus on meeting the needs of patients, physicians, and partners. We are located in Oakville, Ontario. For more information, please visit www.xediton.comREGULATORY AFFAIRS and QUALITY ASSURANCE ASSOCIATE Job Description & Key responsibilities The Regulatory Affairs Associate...
-
Oakville, Ontario, Canada Xediton Pharmaceuticals Inc Full time $65,000**About Xediton Pharmaceuticals Inc.**Xediton is a privately-held pharmaceutical company dedicated to addressing the needs of patients, physicians, and partners.We are committed to meeting the evolving requirements of the industry while fostering a culture of innovation and excellence.**Job Overview:**The Regulatory Affairs Associate will support the...
-
Regulatory Compliance Specialist
4 weeks ago
Oakville, Ontario, Canada Xediton Pharmaceuticals Inc Full time $65,000Xediton Pharmaceuticals Inc is a privately-held pharmaceutical company focused on meeting the needs of patients, physicians, and partners.The Regulatory Affairs Associate will support Drug, Medical Devices, and Natural Health Product registrations with Health Canada. This role involves:Supporting the preparation and filing of Medical Devices and Natural...
-
Corporate Affairs Director
1 day ago
Oakville, Ontario, Canada Ontario Retirement Communities Association (ORCA) Full timeJob OverviewWe are seeking a highly skilled and experienced individual to join our team as the Vice President of Corporate and Public Affairs. This role will be responsible for leading the development and execution of strategic initiatives in government and stakeholder relations, communications, and governance.Salary: The estimated salary for this position...
-
Manager, Regulatory Operations
4 days ago
Oakville, Canada AmerisourceBergen Full time- What you will be doing - PRIMARY DUTIES AND RESPONSIBILITIES: - Prepare and review documents (IND / CTA, NDS / NDA, ANDS/ ANDA, etc.) for submission to Agencies. - Participate in and supprrt project teams - Effectively prioritize, coordinate and complete multiple projects within established timeframes. - Identify client and dossier issues and develop...
-
Coordinator, Regulatory Affairs
2 months ago
Oakville, Canada Cencora Full time**Job Details**: **_Primary Duties and Responsibilities:_** - Build and maintain a positive and productive liaison with internal and external contacts. - Develop professional regulatory and document knowledge and skills in order to provide effective consulting services. - Co-ordinate and compile regulatory submissions, responses to agency questions and other...
-
Regulatory Compliance Specialist
11 hours ago
Oakville, Ontario, Canada Xediton Pharmaceuticals Inc Full time $65,000OverviewXediton Pharmaceuticals Inc is a privately-held pharmaceutical company committed to meeting the needs of patients, physicians, and partners.Job SummaryWe are seeking an experienced Regulatory Compliance Specialist to support Drug, Medical Devices and Natural Health Product registrations with Health Canada.Key ResponsibilitiesPrepare and file Medical...
-
Consultant en Développement Des Affaires
7 months ago
Oakville, Canada ServiceMaster Full time**Consultant en développement des affaires, **Restauration ServiceMaster** - Salaire de base avec avantages sociaux et prime annuelle_ En vous joignant à ServiceMaster Canada, vous ferez partie d'une entreprise leader de l'industrie qui est au Canada depuis plus de 65 ans avec des emplacements d'un océan à l'autre. Chez ServiceMaster, nos employés...
-
Coordinator, Regulatory Operations
2 months ago
Oakville, Canada Cencora Full time**Job Details**: **Primary Duties and Responsibilities**: - Build and maintain a positive and productive liaison with internal and external contacts, including interfacing with potential clients. - Use various internet document transfer sites to download client files and upload files ready to be sent back to our clients. - Use, manage and maintain...
