Director/Consultant, Regulatory Affairs

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.

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.

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