- Ensure compliance to global regulatory guidance documents, regulations and laws, as well as internal policies and procedures.
- Lead/manage regulatory CMC strategy and submission aspects for development programs as assigned.
- Lead/participate in meetings with internal stakeholders and external business partners or teams for clinical development programs or collaborations, in order to communicate regulatory CMC guidance and strategies.
- Ensure regulatory CMC submissions are of high quality, consistent and complete, and comply with current regulatory standards.
- Direct the planning and preparation of CMC focused regulatory submissions for the company’s products and facilitate timely product registrations and regulatory approvals.
- Provide critical review of the CMC data packages from other functional team representatives to support clinical trial and marketing applications.
- Collaborate with Quality Assurance to manage programs and ensure regulatory compliance during product development, validation, and commercialization.
- Work with CMC functional experts to provide timely responses to CMC regulatory questions from global health authorities.
- Liaise with FDA and other health authorities as needed (e.g. telephone contacts, submissions).
- Maintain current knowledge of relevant US and international guidance's, laws and regulations, and proposed and final rules which affect CMC pharmaceutical drug development.
- Participate in outside professional development meetings and conferences to ensure the latest thinking is applied to CMC strategies.
- Collaboration & Teamwork: Advanced competence in collaboration & teamwork, communications influence, strategic agility, planning & organizing, driving results, and problem solving.
- Productivity/Organizing/Planning: Meets deadlines, demonstrates effective use of time, and handles multiple assignments simultaneously.
- Communication/Presentation Skills: Excellent ability to convey both written and verbal information effectively and efficiently and present information to all levels of audiences.
- Willingness to Acknowledge Areas for Growth: Understands need for growth and is receptive to constructive feedback.
- Leadership: Strong ability to establish and communicate clear visioning that team members willingly follow; provide information, knowledge and methods to realize that vision; coordinate and balance conflicting internal and external interests; ability to influence decision-making in a diplomatic manner. Able to navigate team smoothly through difficult situations.
- Strategic Thinking: Capable of thinking conceptually, imaginatively, systematically, and opportunistically to achieve company goals.
Education, prior work experience, and specialized skills and knowledge:
- Minimum of BS/MS degree is required; advanced degree (M.S. or Pharm.D.) in scientific, Regulatory Affairs, or related pharmaceutical field preferred.
- 12+ years of experience in the pharmaceutical, biotechnology or related industry.
- 8+ years of experience in regulatory affairs CMC or a related pharmaceutical development field. Experience with regulatory CMC aspects of both large and small molecule drugs preferred. Experience with global clinical trial and marketing applications, eCTD submissions and electronic document management systems, highly desirable.
- Proven ability to prepare and submit documents to FDA and globally , such as, Investigational New Drug (INDs), and New Drug Applications, (NDAs ), Marketing Authorizations Application (MAA), Clinical Trial Application (CTA) or Investigational Medical Product Dossier (IMPDs).
- Must have experience working with FDA locally and nationally.
- Strong writing, project management and communication skills.
- International CMC regulatory knowledge and experience.