Job Description

Sr. Regulatory Affairs Specialist, CMC/CVM

Relocation Assistance

Direct Hire!

Hybrid work schedule

The Regulatory Affairs Specialist, CMC position is a full-time, direct hire, hybrid role with growing client near St. Louis, MO, offering a salary of $90,000-$110,000 . The position is pivotal in ensuring the client's animal health products meet rigorous regulatory standards, particularly with the FDA's Center for Veterinary Medicine (CVM) .

Job Responsibilities:

The core of this role revolves around the Chemistry, Manufacturing, and Controls (CMC) aspects of veterinary pharmaceuticals, ensuring regulatory compliance and successful submissions.

Regulatory Compliance & Submissions:

• Prepare, review, and submit high-quality post-approval CMC regulatory submissions and correspondence to the FDA/CVM . This is the primary output, ensuring that changes or updates to existing animal drug products are approved by the regulatory authority.
• Collaborate with the CMC team on submission strategy and content, highlighting the need for teamwork.
• Maintain accurate records and ensure timely archiving of all regulatory documents.
• Participate in regulatory negotiations to support submission approvals, indicating a need for communication and persuasive skills.

Regulatory Strategy & Intelligence:

• Monitor regulatory changes, industry trends, and FDA updates to inform and shape compliance and post-approval strategies. This requires proactive learning and staying current with the evolving regulatory landscape.
• Share regulatory intelligence and guidance with internal teams (R&D, Quality, Marketing), emphasizing a role as an internal expert and educator.
• Participate in industry groups to advocate for sound regulatory practices, suggesting external engagement.

Cross-Functional Collaboration:

• Engage with internal teams to troubleshoot product issues and coordinate timely documentation for CVM submissions. You'll act as a liaison, ensuring that technical and operational issues are translated into regulatory action.
• Support cost-saving initiatives and process improvements through regulatory insights, showing that the role contributes to business efficiency.
• Provide support during FDA inspections and internal audits , indicating involvement in quality assurance processes.

Regulatory Agency Relationships:

• Cultivate productive, professional relationships with CVM and other regulatory authorities, underscoring the importance of diplomacy and effective communication with regulators.
• Represent the company in industry working groups and forums to shape the regulatory environment.

Job Requirements:

• Bachelor's degree in Chemistry, Biology, Animal Science, or a related field, or equivalent industry experience.
• 2–4 years of regulatory affairs experience , with at least 1 year specifically in veterinary pharmaceuticals . This is a critical requirement, emphasizing the niche nature of the role.
• Experience with FDA submissions and CVM experience is required.
• Prior involvement in regulatory meetings or informal communications with the FDA is a definite plus, indicating comfort and experience with direct agency interaction.

Skills & Attributes:

• Excellent technical writing and document management skills are paramount for preparing submissions.
• Strong attention to detail and organizational capabilities are essential for managing complex regulatory documents and timelines.
• Proven ability to navigate complex regulations and produce results under tight timelines , highlighting the pressure and analytical demands of the role.
• Collaborative mindset with the ability to work across functions and influence outcomes, reinforcing the cross-functional nature.
• Proficiency in Microsoft Office, Google Workspace, Adobe Acrobat , with eSubmitter experience being a bonus (as it's FDA's electronic submission portal).
• Ability to grasp and communicate scientific and regulatory concepts clearly .
• Comfort working in a dynamic, evolving regulatory environment .
• Willingness to travel up to 5% of the time.

This role offers an excellent opportunity for a regulatory professional with veterinary pharmaceutical experience to significantly impact product lifecycle management and compliance within a growing organization.

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