Assistant Director/Director Regulatory Affairs

1 week ago


Trenton, New Jersey, United States Scientific Search Full time
Assistant Director/Director of Regulatory Affairs

Location:
Summit, NJ

5 days on site

Step into the realm of regulatory strategy and compliance as the Assistant Director/Director of Regulatory Affairs.

This pivotal role is designed for a visionary who thrives on regulatory frameworks and is passionate about steering biologic products through the complex approval processes of health authorities worldwide.

Why You Should Apply

Shape the regulatory pathways for innovative small molecule, large molecule or biologic products with your strategic insights.
Engage directly with global health authorities, including the FDA and EMA, enhancing our compliance and product outreach.

Be part of a team where your expertise in regulatory strategy and biologics will have a direct impact on public health.

Opportunity to work with cutting-edge regulatory submission software, staying ahead in the dynamic pharmaceutical landscape.
Enhance your professional growth in a role that values your contributions and offers pathways for advancement.

What You'll Be Doing

Assisting with the formulation of regulatory responses and navigating global health guidelines.
Providing strategic regulatory advice on either small molecule, large molecule or biologic products, ensuring compliance and innovative solutions.
Managing change controls, deviations, and CAPA from the manufacturing unit with a keen eye for detail and quality.
Playing a key role in the preparation and submission of INDs, NDAs, BLAs, and ensuring adherence to eCTD formatting.
Engaging with and contributing to the compilation of critical documentation and information from clients and stakeholders.

About You

Hold an advanced degree in the sciences with a rich background of 8+ years in the pharmaceutical industry.
Deep understanding of regulatory requirements and guidelines, with a preference for CMC knowledge.
Familiarity with Veeva Vault, Lorenz DocuBridge, and RAC certification will be highly advantageous.
Exceptional communicator, adept at both the written and spoken word, capable of simplifying complex regulatory principles.

No third party. All applicants must be US Citizens or Permanent Residents, as sponsorship is not provided by the client.

How To Apply

Connect with us by sending an email to expressing your interest in this position. Feel free to include your resume. Please mention Job# 18616

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