Regulatory Affairs Specialist

About Freyr

Freyr is a fast-growing, innovative company specializing in providing end-to-end regulatory solutions and services for the Life Sciences industry. With a commitment to excellence and innovation, we assist pharmaceutical, medical device, and biotech companies in navigating the complexities of regulatory compliance.

Why Freyr?

At Freyr, we believe in fostering a collaborative and dynamic work environment that empowers our team to make a real impact. As we expand our footprint , we are on the lookout for passionate and skilled Regulatory professionals to join us in shaping the future of regulatory services.

Join Our Team:

If you're ready to embark on a journey of growth and innovation, connect with us to explore the exciting opportunities awaiting you at Freyr. Together, we can shape the future of regulatory solutions.

📢 To Apply:

Please apply to this job post or you can visit our Careers page for more openings

Visit our Careers page at (https://www.freyrsolutions.com/careers/current-positions) to explore current job openings and submit your application.

Don't miss this chance to be a part of Freyr's expansion and make your mark in the world of regulatory services. Let's redefine regulatory excellence together!

Title:Regulatory Affairs Specialist / Sr. RA Specialist

Location: Remote( Base location should be in UK / EU, preferably in UK , Hungary/ Poland / Romania/ Czech/ Croatia).

Experience : 4 to 6 years in Regulatory Affairs.

Key Skills :Rest of World Experience, Lifecycle management, Labelling, PSUR, Safety Reports

Regional Regulatory Liaison Support

Role Summary

Support a regional regulatory lead (RRL) in the EU, or IC/GPS (RoW) region

Support execution of RA/regional strategy for assigned projects by:

Providing support as defined by the RRL, to help advance the project in-line with client’s Corporate Objectives and governance goals

Participating in regulatory project teams and development forums

Working across franchises or TAs as assigned

Building and maintaining partnerships with other members of RA

Acting as a delegate for RRL, as appropriate

Key Activities:

Activities associated with this role may include, but is not limited to:

Provide support in the preparation of regulatory submissions for investigational and commercial products, including clinical study applications and supplements to marketing authorizations in line with ICH requirements, regional requirements and scientific and company policies and procedures

Work with functional sub-teams to develop a timeline based on data availability and other critical path activities. Identify the critical path to submission. Maintain timeline during the project lifecycle.

May be required to handle routine labelling changes and drug listings

With guidance, works to develop and acquire required regulatory skills and knowledge

May contribute to routine local process improvements, which have an impact on the working of the Regulatory Affairs function.

May act as a resource on a specific topic for other Regulatory personnel within the department

Work is performed under the supervision of Regulatory Affairs professionals following detailed instruction with well-defined procedures

Experience & Skillset

Position Overview

Act as support to the Regional Regulatory Liaison for the assigned products, compounds, indications or projects in the assigned therapeutic area. Will be typically assigned multiple products or projects to manage simultaneously, with guidance, may lead the regulatory activities for assigned products or projects.

Example Responsibilities

Taking the lead regulatory submissions including the preparation, compilation, and timely filing of the submissions, while seeking guidance from more experienced colleagues as needed. Examples include, CTA submissions, MAA amendments, license renewals, license withdrawals, and routine submissions (e.g., Development Safety Update Reports / DSURs, Annual Reports, Periodic Safety Update Reports (PSURs) etc.).

Provide final application packages (e.g. Renewals, labelling support to post-licensing activities including labelling variations, responses to questions, PSUR/RMP) to the client for dispatch to a local partner or Affiliate.

Represents Regulatory Affairs on relevant cross-functional teams and advises cross-functional partners and stakeholders on the requirements and pathway needed to obtain, change or maintain licensure, optimal listing and compliance with regulatory authorities

Provide direction on and managing associated activities and needs for regulatory labelling and packaging

Makes significant contributions to the ongoing development and refinement of regulatory strategies, processes, standards, and practices

Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.

Requirements

Rest of World Education & Experience

BA/ BS or advanced degree in life sciences or related field with some regulatory experience or related work experience in the biopharma industry, regulatory agency, clinical research or other related healthcare environment.

Knowledge & Other Requirements

• Knowledge of relevant health authorities, including people, system, processes and requirements.
• Performs a broader range of regulatory affairs activities with supervision from more experienced colleagues.
• Able to advise cross-functional partners on standard regulatory requirements and pathways needed to meet regulatory and other business goals and objectives.
• Completes most core regulatory affairs activities for moderately complex products and filings that enable other Global TA Regulatory Liaison colleagues to focus on more complex products or projects
• Basic understanding of role of Regulatory Affairs and regulatory requirements in a limited number of areas is required
• Strong interpersonal skills and understanding of team dynamics.
• Strong communication and organizational skills.
• Strong negotiation and conflict resolution skills.