Director / Consultant of Regulatory Affairs

Cencora, Inc.; Ontario; On-site; CAD 133,000 - 206,000; Full time

Job summary

Join a leading company dedicated to improving health outcomes as a Regulatory Affairs expert. This role involves managing complex regulatory submissions and client relationships, ensuring compliance, and leading cross-functional teams. With a focus on innovation and professional growth, you will have the opportunity to make a significant impact in the pharmaceutical industry. The company offers a comprehensive benefits package and a commitment to inclusivity.

Benefits

Medical Care

Dental Care

Vision Care

Paid Parental Leave

Professional Development Resources

Qualifications

• 12+ years of relevant experience in clinical regulatory affairs.
• Regulatory Affairs Certification (RAC) and other certifications are an asset.

Responsibilities

• Prepare Health Canada drug submission content for pharmaceutical products.
• Lead and manage multiple simultaneous projects to meet client expectations.
• Develop and maintain partnerships with senior decision-makers.

Skills

Project Management

Analytical Skills

Leadership

Communication

Problem Solving

Education

B.Sc. degree in life sciences

Advanced Degree in related field

Tools

Microsoft Word

Excel

Adobe Acrobat

Microsoft Outlook

Job description

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!

Primary Duties and Responsibilities :

• Previous Regulatory Affairs experience with preparing Health Canada drug submission content for pharmaceutical and biologic products (Module 1 Product Monograph, labels, Risk Management Plan, CS-BE; Module 2 clinical and non-clinical overviews and summaries, pre-NDS meetings, priority review requests, clinical assessment package, PRCI)
• Responsible for preparing client proposals and generating new business for Innomar Strategies / 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
• Responsible for development and implementation of RA activities including regulatory assessments, strategies, submissions and agency interactions, applying expert knowledge in core area of regulatory practice (clinical, non-clinical, labelling) 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 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 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
• 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 clinical regulatory affairs
• Regulatory Affairs Certification (RAC) and other certifications are an asset
• Prior consulting experience is preferred.

Minimum Skills, Knowledge and Ability Requirements :

• Broad understanding of international regulations, processes and issues in drug / biologics development. Includes sound knowledge of ICH, Health Canada, FDA, EMA, and other relevant guidelines with focus in area of specialization such as biologics, pharmaceuticals, Clinical Trials, or OTC / NHPs
• 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
• 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 deadlines
• Knowledge of computers, to operate 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 caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more.

Full time.

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email [emailprotected] . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

Accessibility Policy

AmerisourceBergen is committed to fair and accessible employment practices. When requested, AmerisourceBergen will accommodate people with disabilities during the recruitment, assessment and hiring processes and during employment.

Salary Range

133,200 CAD - 205,260

Affiliated Companies :

Affiliated Companies : Innomar Strategies