| Job Description | or New Haven, CT or Phillipsburg, NJ
Overview:
Celldex is a clinical stage biotech company with multiple clinical programs from First in Man to Phase 3. We have an excellent opportunity for the right applicant to be responsible for leading the regulatory affairs department in regulatory strategy and compliance activities for development stage drug and biologic programs as well as future US and international commercial activities. The successful candidate will have an in-depth knowledge and understanding of global regulations and guidelines with experience in the preparation and submission of regulatory documents. A strong knowledge base in Clinical Regulations is essential and strength in progressive approval strategies is a must. A successful candidate will have supervisory/management experience in the biotech/pharmaceutical industry and direct experience interacting with regulatory agencies including the FDA.
Position Responsibilities:
Assuming leadership role in developing and guiding regulatory staff on strategic planning of Investigational New Drug/Biologic License/New Drug Applications (IND/BLA/NDA) and international filings to support successful development programs in multiple indications in the US and globally
Ensure that projects have a clearly defined regulatory pathway and milestones leading to successful filings and approvals
Oversee preparation of global regulatory development plans and management of key regulatory timelines and critical path activities
Providing a primary liaison with the Food and Drug Administration (FDA) and other global regulatory authorities
Interpretation and application of global regulations and guidelines with an emphasis on clinical regulations
Collaboration with departments to generate regulatory documents. Manage these documents thru internal cross departmental review cycles for scientific adequacy; manage resolution of comments from internal departmental reviewers to finalize documents for regulatory filings to regional authorities within specified deadlines and consistent with the highest quality standards
Providing primary regulatory review of applications to ensure sections are well written, timely and in compliance with internal and external standards
Develop and manage regulatory budgets and resources
Regularly communicate progress, issues, information and performance to plan to senior management and other relevant parties
Job Requirements:
Biologics drug development experience
Experience in preparing regulatory strategies
Previous experience in a senior regulatory role
Experience interacting with regulatory agencies
Supervisory experience
Experience with the full spectrum of Regulatory Affairs
Multi-lingual skills a plus
Education/Experience:
Minimum of BS or BA degree in a scientific discipline and/or equivalent experience; Doctorate degree a plus
10 years of Industry and at least 8 years of Regulatory Affairs experience |
| | Company | | Celldex Therapeutics | Job Code | | State or Province | | Massachusetts | | |
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