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Director/Consultant, Regulatory CMC

Innomar Strategies

Innomar Strategies

Legal
San Jose, CA, USA · San Antonio, TX, USA · Houston, TX, USA · Phoenix, AZ, USA
Posted on Thursday, June 27, 2024

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.

What your background should look like

EXPERIENCE AND EDUCATIONAL REQUIREMENTS:

  • 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.

MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:

  • 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

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.

Schedule

Full time

Affiliated Companies:

Affiliated Companies: Innomar Strategies

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.