Are you a dedicated individual looking to put your expertise to work fully flexibly in a remote position? Proclinical is seeking a skilled Regulatory Consultant for a remote position!
Proclinical is seeking a Regulatory Consultant to support the preparation and coordination of regulatory submissions for biotechnology products, primarily within the EU-EEA regulatory framework. This role involves providing strategic input and hands-on execution of regulatory documents related to marketing authorization applications, variations, compliance submissions, and regulatory strategies across quality, clinical, and non-clinical domains.
Responsibilities:
* Prepare and coordinate initial invented name applications in line with EMA and national authority requirements.
* Lead and compile Module 1 components of Marketing Authorization Applications (MAAs), including drafting submission requests and supporting public disclosure or HTA interfaces.
* Develop and update Annex I (Summary of Product Characteristics) and Annex II (manufacturer information, GMP/GCP declarations).
* Draft and maintain SmPCs, ensuring alignment with clinical data, QRD templates, and regulatory standards.
* Coordinate Patient Information Leaflet (PIL) user testing, including protocol design, vendor management, and authority interactions.
* Support lifecycle management activities, including Maintenance of Certificate (MoC) submissions, post-approval variations, and change control justifications.
* Draft and submit Pediatric Investigation Plan (PIP) compliance applications and modifications.
* Advise cross-functional teams on regulatory requirements, timelines, and dossier expectations.
* Act as the regulatory point of contact for national competent authorities and EMA rapporteurs.
Key Skills and Requirements:
* Degree in Life Sciences, Pharmacy, or a related field; advanced degrees (e.g., PhD, PharmD) are a plus.
* Experience in regulatory affairs within the pharmaceutical or biotech industry, with a focus on EU regulatory procedures.
* Proven expertise in authoring and managing EU MAA documentation and lifecycle submissions.
* Previous history in Rare/Ophan disease is useful.
* Strong knowledge of EU regulatory guidelines, QRD templates, GxP principles, and procedural timelines.
* Proficiency in electronic submission systems (e.g., eCTD, CTIS, CESP) is preferred.
* Excellent written and verbal communication skills in English.
* High attention to detail, with the ability to manage multiple priorities and meet deadlines.
* Collaborative mindset with the ability to work independently and in cross-functional teams.
If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at p.duvall@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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