Company: Arkea Bio Corp.

Role: Regulatory Affairs Specialist

Manager: Senior Lead, Clinical Development

Location: Preferably Hybrid (Boston/Remote)

Travel: Less than 25%

Type: Full-Time

Job Summary:

The Regulatory Affairs Specialist will be responsible for the preparation, and review of regulatory documents for a novel veterinary product in various international jurisdictions. This role requires a solid understanding of regulatory requirements, excellent organizational skills, and the ability to work independently while collaborating with internal teams and external consultants.

Duties/Responsibilities:

• Prepare, and review regulatory documents for novel veterinary product applications across multiple international jurisdictions, ensuring compliance with each region's regulations.
• Assist in the development of regulatory strategies to facilitate timely approvals and optimize submission processes; work in consultation with external consultants who are experts in their respective jurisdictions, ensuring alignment with regulatory requirements and timelines.
• Employ creative problem-solving skills to identify opportunities to accelerate regulatory approval timelines and/or parallelize submission efforts.
• Collaborate with internal teams, including R&D, and manufacturing, to gather necessary data and documentation for submissions.
• Monitor submission timelines and regulatory updates, communicating with regulatory authorities as necessary, to ensure project milestones are met.
• Respond to inquiries from regulatory authorities and prepare necessary documentation for follow-up requests.
• Maintain organized records of all submissions, correspondence, and regulatory documentation.

Required Skills/Abilities:

• Bachelor’s degree in a relevant field (e.g., veterinary science, biology, pharmacology).
• Minimum of 8-10 years experience in regulatory affairs, preferably related to veterinary products.
• Knowledge of regulatory processes and requirements in one or more international jurisdictions.
• Strong analytical and creative problem-solving abilities.
• Excellent written and verbal communication skills.
• Ability to manage parallel jurisdictional submission timelines effectively.
• Proficient with Microsoft Office Suite and, preferably, relevant regulatory submission software and Google Workspace (i.e., Google Docs).

ArkeaBio is deeply committed to diversity, equity, and inclusion in all of its practices, especially when it comes to growing our team. Our culture promotes inclusion and embraces the personal and organizational benefits of working with people from all walks of life. It is the policy of ArkeaBio to provide equal employment opportunities to all employees and employment applicants.

ArkeaBio offers 100% paid health, vision, dental and life insurance, up to a 4% matching contribution to a 401(K) retirement account and unlimited paid time off. ArkeaBio has a 13,000 square foot lab in Charlestown, MA, and offers a flexible work environment. This is a US-based role. Candidates must be eligible to work in the US. ArkeaBio does not offer sponsorship, except in very limited circumstances decided on a case-by-case basis. ArkeaBio participates in eVerify.