Director Regulatory Affairs

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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