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!

Job Details

Primary Duties and Responsibilities:

Previous RA 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 presentationsPrioritize and manage multiple simultaneous projects to meet budget (including invoice review), timelines and client expectations; anticipate and resolve emerging issuesResponsible 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 areaMaintain target billables by obtaining new businessCreates opportunities to build agency relationships by participating in professional activities such as offering industry training, conference presentations, publications and webinarsLeads 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 improvementDevelop and maintain partnerships with senior decision-makers to build the business, resolve significant issues, and create opportunitiesAnalyze 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 teamsProactively identifies, shares and interprets regulatory intelligenceManage 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 developmentTravel as requiredOther 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 preferred12+ 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 requiredRegulatory Affairs Certification (RAC) and other certifications are an assetPrior 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 basisIn depth regulatory expertise in the area of regulatory specialization required for the role, such as medical devices, CMC, or advertising/promotionExtensive 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 environmentAdvanced strategic planning and complex problem-solving skills to resolve complex issues with innovative solutions effectively and efficientlyDemonstrated senior leadership abilities in a cross-functional, multi-disciplinary team environment.Ability to drive results in a team environmentStrong business and financial acumenStrong analytical and mathematical skillsAbility to communicate effectively both orally and in writing;Excellent presentation skillsExcellent leadership and interpersonal skillsEffective organizational skills; attention to detailAbility to consistently meet deadlineKnowledge 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 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

Equal Employment Opportunity

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 hrsc@cencora.com. 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

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

Affiliated Companies:Affiliated Companies: Innomar Strategies