6 дней назад
Senior Regulatory Associate
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Regulatory Associate (Regulatory Affairs): Managing regulatory strategies, marketing authorization applications, variations, renewals, and clinical trial support for human medicinal products with an accent on regulatory compliance, authority engagement, and maintaining product approvals. Focus on developing product regulatory strategies, responding to national authority queries, and supporting the safe and compliant supply of medicines.
Location: United Kingdom – Walton Oaks. Applicants must have the relevant authorization to live and work in the UK.
Company
develops medicines and applies digital, data, modelling, and automation solutions to accelerate drug discovery and development.
What you will do
- Develop regulatory strategies and advise cross-functional and divisional teams.
- Manage new registrations, marketing authorization applications, variations, renewals, and national regulatory authority queries.
- Support clinical development activities with regulatory authorities and internal regulatory strategy teams.
- Maintain regulatory databases and obtain approvals for unlicensed medicine supply, including named-patient and compassionate-use programs.
- Safeguard compliance for packaging and prescribing information updates, product discontinuations, divestments, licenses, and supply continuity.
- Contribute to Good Regulatory Practice, regulatory intelligence, group development, and personal development.
Requirements
- Life sciences or chemistry degree to honors level or equivalent.
- Previous experience and a proven track record in regulatory affairs for human medicinal products.
- Excellent written and verbal communication skills.
- Strong analytical thinking and computer literacy.
- Master’s degree, postgraduate diploma, PhD, or relevant professional qualifications are preferred or desirable.
- Relevant authorization to live and work in the UK is required.
Culture & Benefits
- Patient-centric culture focused on improving patients’ lives.
- Values-led environment emphasizing courage, joy, equity, and excellence.
- Flexible workplace culture supporting work-life harmony.
- Inclusive workplace with reasonable adjustments available for disabled applicants.
- Digital transformation initiatives using data, modelling, and automation to enhance health outcomes and patient experience.
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