We are seeking experienced Regulatory Affairs Writers with specialized knowledge in Biologics, Medical Devices for Combination Products, or Combination Products to write Biologics License Application (BLA) submissions and participate in FDA interactions. 

These consultants will play a key role in writing/authoring BLAs, ensuring compliance with FDA regulations, and providing strategic regulatory guidance when applicable.

We are looking for at least three consultants, each with FDA regulatory submission writing experience in at least one of the following areas; experience in more than one of these or all three is preferred but not required:

1. Biologics – Expertise in CMC, and clinical and non-clinical sections for biologics BLA submissions.
2. Device for Combination Products – Experience with device-specific requirements in combination product submissions, including design controls, biocompatibility, and human factors.
3. Combination Products – Knowledge of drug and device regulatory pathways, integrating requirements for seamless BLA submissions.

• Write/Author BLA submissions, ensuring alignment with FDA expectations.
• Collaborate cross-functionally with CMC, clinical, quality, and engineering teams.
• Assess and mitigate regulatory risks, ensuring timely and successful approvals.

• At least 2+ years writing BLAs for biologics or combination products. For the device writer, experience writing for Device submissions alone can be sufficient for the right candidate, but writing BLAs is preferred. 
• Proven experience writing/authoring and submitting BLAs to the FDA. Preference will be given to candidates with a proven track record of authoring/writing BLAs that have successfully obtained FDA approval.
• Expertise in relevant FDA regulations and standards, including:
  • Biologics \- 21 CFR Part 600, ICH Q5/Q6, GMP, GLP, GCP.
  • Medical Devices for Combination Products - 21 CFR Part 820, Part 4, ISO 14971, IEC 60601, ISO 10993.
  • Combination Products - PMOA determinations, 21 CFR Part 4, integration of drug and device requirements.
• Experience interpreting and responding to FDA requests for information.
• Familiarity with eCTD submission platforms and regulatory writing tools.
• Strong collaboration and communication skills to work across disciplines and with regulatory agencies.
• Hands-on experience writing BLAs for FDA submission. For the device writer, experience writing for Device submissions alone can be sufficient for the right candidate. 

Location

• International travel required

Employment Type

• W2 with Ventura Solutions and benefits or
• 1099
• Competitive Pay

About Ventura Solutions

Ventura Solutions is a reputable end-to-end medical device and combination product consulting, staffing, and training firm. With our deep industry expertise spanning medical devices and combination products, coupled with an outstanding talent pool, we stand out as the preferred option for a diverse array of projects. On the consulting side, we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects. On the staffing side, we help source, screen, and on-board reputable employees to fill temporary, temp to permanent, and permanent job openings. We accelerate product development, keep products compliant, and help build great organizations. For more information, visit us at www.ventura-solutions.com.

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