Work from Home Regulatory Affairs Specialist Opportunity at Freyr Solutions

Freyr Solutions is seeking talented individuals for the position of Regulatory Affairs Specialist. This is a fantastic chance for professionals located in Europe to join a leading company in the life sciences industry and work from the comfort of their homes.

About Freyr Solutions

Freyr Solutions is a fast-growing, innovative company specializing in end-to-end regulatory solutions for the life sciences industry. We assist pharmaceutical, medical device, and biotech companies in navigating the complexities of regulatory compliance with our commitment to excellence and innovation. As we expand our footprint to Warsaw, Poland, we are on the lookout for passionate and skilled regulatory professionals to join our team.

Why Join Freyr Solutions?

At Freyr, we foster a collaborative and dynamic work environment that empowers our team to make a real impact. We offer opportunities for growth, innovation, and making significant contributions to the regulatory field.

Job Details

Title: Regulatory Affairs Specialist
Years of Experience: 4 years in Regulatory Affairs (Pharma)
Location: Remote (Base location should be in Europe)
Mandatory Skills: Experience in EU Central Procedure and in biological products/vaccines

Key Responsibilities

• Understand the regulatory framework, including regional trends, for various types of post-approval change applications and procedures across all regions.
• Evaluate change control and provide regulatory assessment on procedural and documentation requirements as defined by health authorities.
• Review submission documents and provide regulatory input for variations, response documents, regulatory maintenance documents, aggregate safety reports, etc.
• Use and share best practices, regulatory updates, and lessons learned in day-to-day work.
• Contribute to planning, preparation, and delivery of both simple and complex regulatory maintenance submissions.
• Liaise closely with cross-functional team members with aligned product responsibilities.
• Execute and maintain submission deliver plans and content plans, providing status updates to stakeholders.
• Identify regulatory risks and communicate mitigation strategies to cross-functional teams.
• Contribute to various safety reports and addendum statements for submission in assigned regions worldwide.
• Coordinate, plan, and prepare submissions for post-marketing or post-approval changes such as variations, renewals, MAH transfers, other submissions, and responses to health authority queries.
• Prepare applicable Module 1 documents for submissions and briefing documents for scientific advice.
• Coordinate with EU and global teams for inputs on strategies and timelines of all submissions.

How to Apply

Interested candidates are invited to apply online at Freyr Solutions Careers Page. Alternatively, you can visit our LinkedIn job posting to submit your application.