Clinical Regulatory Manager

Location: Full Remote

Contract: Freelance or flexible collaboration, with long-term potential

Concerning PMC:

PMC operates as an innovative company with a primary focus on the rigorous advancement of clinical research and the strategic introduction of novel treatments to patients.

Originating from a small team of four visionaries, PMC has now evolved into a leading company in Romania, with an expanding footprint across the EU and beyond.

Its narrative is one of consistent growth, fueled by an unwavering commitment to excellence and innovation.

Its fundamental mission remains steadfast: to deliver tailored, strategic solutions with competence, professionalism and respect.

Every project, every collaboration, every innovation reflects its relentless drive to establish new benchmarks within the pharmaceutical landscape.

Today, PMC stands as a name synonymous with trust and expertise, underpinned by a diverse team of Experts adept at managing complex EU and non-EU projects with precision and insight, strategic partnerships with both national and international organisations amplifying the reach and impact of its endeavors, academic collaborations that maintain its position at the forefront of R&D, advanced Clinical Trial Units ensuring cutting-edge contributions to Science and Medicine, and pioneering AI-driven projects that are actively shaping the future of Healthcare through Technology.

Positional Overview:

Clinical Regulatory Manager shall be responsible for the diligent administration and precise coordination of regulatory activities pertaining to PMC clients' Clinical Trials.

This role encompasses the meticulous preparation and timely submission of regulatory documents, the unwavering assurance of compliance with applicable regulations and guidelines, and the comprehensive provision of support for interactions with Health Authorities.

A requisition is active for a detail-oriented and proactive Clinical Regulatory Manager to provide comprehensive support to clinical development programs through the diligent administration of regulatory submissions and the unwavering assurance of compliance.

Principal Responsibilities:

· Support the definition and implementation of regulatory strategies for Clinical Trials (CTA, IND) and subsequent development phases.

· Manage the preparation, review and submission of clinical regulatory documentation (e.g. IMPD, IB, study protocol, CSR).

· Coordinate and monitor regulatory activities in collaboration with internal teams, clients and Health Authorities.

· Ensure documentation compliance with ICH-GCP and the other applicable legislation (EMA, FDA, MHRA, AIFA, etc.).

· Support interactions with Health Authorities (Scientific Advice, pre-submission meetings, Q&A).

· Maintain regulatory updates and help assess their impact on ongoing projects.

· Contribute to the drafting of SOPs and continuous improvement of internal regulatory processes.

Requisite Qualifications and Proficiencies:

· Degree in scientific disciplines (Pharmacy, Biology, Biotechnology, Chemistry, Medicine, or similar).

· 3-5 years of experience in Clinical Regulatory Affairs, preferably in a consulting and/or CRO.

· Working knowledge of ICH-GCP and submission processes (e.g. CTA, IND).

· Experience in preparing or reviewing clinical regulatory documents (IMPD, IB, study protocol, etc.).

· Ability to manage projects and interact with multidisciplinary teams.

· Fluent written and spoken English.

· Accuracy, detail orientation and ability to work independently.

Application Procedure:

Interested candidates are invited to send a Curriculum Vitae and a presentation letter, outlining in detail their suitability for the above position, to specifying in the object of the e-mail "Application for Clinical Regulatory Manager".

PMC functions as an employer adhering to principles of equal opportunity.

Diversity is celebrated, and a steadfast commitment to the creation of an inclusive environment for all personnel is rigorously maintained.

Job Type: Commission