Regulatory Affairs Specialist

JR United Kingdom; Woking; Remote; GBP 40,000 - 70,000; Full time

Job summary

A leading company in the Life Sciences industry is looking for a Regulatory Affairs Specialist to join their innovative team. In this remote role, you will support regulatory submissions and develop strategies, making a significant impact on the future of regulatory services. Candidates with 4 to 6 years of experience are encouraged to apply and be part of shaping regulatory excellence.

Qualifications

• 4 to 6 years in Regulatory Affairs.
• Knowledge of relevant health authorities, systems, and processes.
• Strong interpersonal, communication, organizational skills.

Responsibilities

• Support execution of RA/regional strategy for assigned projects.
• Lead regulatory submissions including CTAs, MAA amendments.
• Represent Regulatory Affairs in cross-functional teams.

Skills

Rest of World Experience

Lifecycle management

Labelling

PSUR

Safety Reports

Education

BA/BS or higher in life sciences or related field

Job description

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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 looking 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 at Freyr. Together, we can shape the future of regulatory solutions.

? To Apply:

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

https://www.freyrsolutions.com/careers/current-positions

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

Job Title

Regulatory Affairs Specialist / Sr. RA Specialist

Location

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

Experience

4 to 6 years in Regulatory Affairs.

Key Skills

Rest of World Experience, Lifecycle management, Labelling, PSUR, Safety Reports

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 may include, but are not limited to:

• Preparing regulatory submissions for investigational and commercial products, including clinical study applications and supplements to marketing authorizations, in line with ICH, regional requirements, and company policies
• Developing timelines based on data availability and critical path activities, maintaining timelines during the project lifecycle
• Handling routine labelling changes and drug listings
• Developing regulatory skills and knowledge with guidance
• Contributing to local process improvements impacting Regulatory Affairs
• Serving as a resource on specific topics within the department
• Performing work under supervision following detailed instructions and procedures

Experience & Skillset

Position Overview: Act as support to the Regional Regulatory Liaison for assigned products, managing multiple projects simultaneously, and leading regulatory activities as appropriate.

Responsibilities include:

• Leading regulatory submissions, including CTAs, MAA amendments, license renewals, and safety reports
• Preparing final application packages for dispatch
• Representing Regulatory Affairs in cross-functional teams and advising on licensure, listing, and compliance requirements
• Providing guidance on regulatory labelling and packaging
• Contributing to the development of regulatory strategies and standards
• Ensuring compliance with practices, policies, and regulatory requirements

Requirements

Education & Experience: BA/BS or higher in life sciences or related field with regulatory experience or relevant healthcare industry experience.

Knowledge & Other Requirements:

• Knowledge of relevant health authorities, systems, and processes
• Ability to perform regulatory activities with supervision
• Advising cross-functional partners on regulatory pathways
• Managing core regulatory activities for moderately complex products
• Basic understanding of Regulatory Affairs role and requirements
• Strong interpersonal, communication, organizational, negotiation, and conflict resolution skills