Regulatory affairs Jobs in Cambridge ma
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ArkeaBioBoston, MA, US- Full-time
Job Description
Job Description
Salary : Commensurate with experience
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 :
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.
remote work