Clinical Regulatory Director

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 Director shall be charged with the meticulous formulation and expert execution of global regulatory strategies for PMC clients' clinical development pipeline.

This senior leadership appointment involves the precise provision of expert regulatory counsel to cross-functional teams, the discerning direction of interactions with Health Authorities, and the comprehensive superintendence of the preparation and submission of high-caliber regulatory dossiers (e.g., INDs, CTAs, NDAs, MAAs).

A strategic and extensively experienced Clinical Regulatory Director is hereby sought to assume leadership of the regulatory strategy pertaining to clinical development programs.

Principal Responsibilities:

· Develop regulatory strategies for Clinical Trials (IND, CTA) and registrations (NDA, MAA, BLA).

· Oversee the preparation of regulatory submissions and manage interactions with Health Authorities.

· Advise clients on clinical, GCP and regulatory development issues.

· Coordinate multidisciplinary teams and ensure delivery of projects on time and on budget.

· Monitor international regulatory changes and interpret their impact on ongoing projects.

· Participate in the development of scientific and educational content (white papers, webinars, advisory boards).

Requisite Qualifications and Proficiencies:

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

· At least 5 + years of Clinical Regulatory Affairs experience.

· Solid knowledge of international regulations and guidelines (ICH-GCP, EMA, FDA).

· Proven experience in clinical regulatory submissions (IND, CTA, MAA, NDA, BLA).

· Ability to coordinate projects and interact with Health Authorities.

· Excellent communication skills, strategic orientation and problem-solving.

· Fluent written and spoken English.

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 Director".

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