Regulatory Affairs Executive (Pharma)

Salary: £42,000 – £45,000 per year

We have an exciting position for an experienced Regulatory Affairs individual with UK and EU experience, to work for a leading pharma company.

If you have 2 years or so experience of working in Regulatory Affairs in the UK and are qualified in any of the following: Pharmacist, Master’s degree in a biology, life science, health science curriculum, or regulatory science with biology curriculum, OR Bachelor’s degree in a science discipline (biology, life science, health science), then this could be just the role for you at this exciting, hugely developing pharma company.

Location: Luton, Beds

Salary: £42,000 – £45,000

Benefits:

* 25 days holiday, plus bank holidays

* Private health insurance (post probationary period)

* Private dental insurance (post probationary period)

* Life assurance

* Free parking

* Flexibility on working (post probationary period)

* Training and development

Hours: 36.5 hours per week Mon – Thurs 9am – 530pm Fri 9am – 430pm (some flexibility is possible)

Role Responsibilities Overview:

* Prepare with the coordination of the headquarter RA team high quality regulatory filings for the products approved in Europe and UK to be submitted in MENA PA region

* Act as a contact with regulatory agencies (MHRA and any EU regulatory agency) in fulfilling local obligations for processing all product and manufacturing site certificates (CPP, GMP…)

* Coordinating with internal stakeholders and providing documents required for tender participation (e.g. prequalification and qualification documents) and RFQ (request for quotation) in a set timeline.

* Provide the latest approved prescribing information, patient information leaflets, packaging components as per the EU/UK label changes and provide comparison table in case of any update

* Coordinating with Finance for data/expenses reporting

* Maintain regulatory and regulation databases

* Any other work assigned by the superiors

Skills, Knowledge and Competencies Required

Knowledge

Adequate knowledge of drug legislation, regulatory landscape, guidelines & submission procedures in EU countries & MHRA &/or MENA Region along with knowledge of eCTD, CTD and country specific format for dossier preparation.

Skills
An excellent communicator – both oral and written

The ability to understand and communicate scientific/clinical information
Great organizational skills
Document management and archiving practice

The ability to recognize and escalate potential issues

Competencies

An Organized and well-structured individual with the ability to work under pressure

You will be able to work independently with minimal supervision, so good problem solving skills is a must

Excellent attention to detail is key for this role

So, if you are looking for that next career move in this leading industry sector and believe you have what it takes to perform this exciting role, then please send your CV to James Newbury Appointments for immediate review. If you do not have a response within 3 working days, unfortunately, you will not have been shortlisted. Thank you for applying and do keep an eye for other potentially suitable roles if this is the situation.