Director/Consultant, Regulatory CMC

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!

What you will be doing

PRIMARY DUTIES AND RESPONSIBILITIES:

• Participates as a member of the management team to direct and manage the affairs of the company.
• Build and maintain a positive and productive liaison with internal and external contacts, including interfacing with potential clients/agencies.
• Act as primary contact for clients with responsibility for maintaining client relationships, including quoting, invoice reconciliation and performing/reviewing client work.
• Responsible for the overall management of key accounts, once acquired, to ensure compliance with client internal review process and all required external approvals.
• Develop and maintain partnerships with senior decision-makers within all departments to effectively achieve business results
• Facilitation of CMC regulatory affairs activities for pharmaceutical, biologics, natural health product clients.
• Lead, participate in and support project team(s) with CMC regulatory updates and strategies as applicable.
• Effectively prioritize, coordinate and complete multiple projects within established timeframes.
• Overall responsibility for CMC aspects of regulatory submissions (e.g. NDS, NDA, IND), regulatory assessments, agency meetings and consulting services.
• Project Management to ensure that assigned projects meet budget / quote timelines and maintain company goals and client expectations.
• Maintain professional regulatory knowledge in order to provide effective consulting advice.
• Develop and manage regulatory direct reports, including but not limited to assignment delegation, time and budget management, skill and knowledge.
• Other related duties as assigned.

• B.Sc. / M.Sc. degree in life sciences (Pharmacology, Molecular Biology, Biology, Chemistry or Pharmacy).
• 10-15 years direct CMC experience in Regulatory Affairs including biologics within the pharmaceutical industry.
• Leadership skills and/or consulting experience.

• Effective project and people management skills including the ability to complete projects within established client and agency timelines.
• Demonstrated strategic planning and problem-solving skills to determine innovative solutions to complex issues.
• Demonstrated leadership abilities in a cross-functional, multi-disciplinary team environment.
• Direct experience and working knowledge of a wide range of regulatory submissions types.
• Experienced in writing and reviewing Module 3 and Module 2.3 section for NDS/NDA.
• Strong business and financial acumen
• Strong analytical and mathematical skills
• Ability to communicate effectively both orally and in writing
• Effective interpersonal and leadership skills
• Effective organizational skills; attention to detail
• Ability to consistently meet deadlines
• Excellent problem-solving skills; ability to resolve issues effectively and efficiently
• Excellent presentation skills
• Proficient with Microsoft Word, Excel, PowerPoint and other Office Programs