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: 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 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 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 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 Cencora is a leading global pharmaceutical solutions company that is committed to improving the lives of people and animals everywhere. We connect manufacturers, providers, and patients to ensure that anyone can get the therapies they need, where and when they need them. We’re a purpose-driven organization, where all of our team members around the world are united in our responsibility to create healthier futures. We work together every day to help our partners bring their innovations to patients worldwide, creating unparalleled access and impact at the center of health. Recruitment scams are on the rise and the intent is to target individuals looking for employment opportunities. To protect yourself, we urge you to be vigilant and follow these guidelines. 1.) Research the Company: Thoroughly research any company before applying or sharing personal information, check their website, read reviews, and verify their legitimacy. 2.) Be Wary of Unrealistic Promises: Exercise caution If a job posting offers high salaries and minimal qualifications. Legitimate jobs will have realistic expectations and provide detailed job requirements. Jobs at Cencora can be found on Cencora.com/careers 3.) Guard Your Personal Information: Only share sensitive information after vetting the employer’s credibility. Avoid sharing your Social Security number, bank account details, or identification documents during the application process. Cencora does not request this information as part of the employment application. 4.) Avoid Upfront Payments: Legitimate employers do not require payment during the hiring process. Be suspicious if you are asked to pay for training materials, processing fees, or background checks before securing a job offer. Cencora will never ask you for payment information during the hiring or onboarding process. 5.) Verify Communication Channels: Scammers often use free email services or chat platforms without providing an official company contact information. Cencora recruiters will have an email address ending in @cencora.com, @alliance-healthcare.net, @alliance-healthcare.co.uk, alliance-healthcare.fr or alliance-healthcare.ro Remember to stay vigilant and informed about common scam tactics to reduce the risk of falling victim to fraudulent employment schemes. If you believe you have encountered a job scam posing as a Cencora opportunity, please report it immediately to: GlobalTalentAcquisition@Cencora.com
