Regulatory Affairs Manager – Food Supplements, Homeopathics & FSMPs

Concerning PMC

PMC operates as a company characterised by its dynamic nature and sustained accretive development.

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.

PMC is unequivocally dedicated to fostering innovation and advancing global health through the provision of cutting-edge pharmaceutical solutions.

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

We are looking for a Regulatory Affairs Manager with proven experience in managing regulatory activities for food supplementshomeopathic medicines and Foods for Special Medical Purposes (FSMPs). The selected candidate will lead technical strategy and execution for key client projects and support PMC’s management team on high-level regulatory operations.

Principal Responsibilities

🔹 Define and manage regulatory strategies for food supplements, homeopathics and FSMPs

🔹 Oversee and/or prepare technical documentation, product notifications, labelling and dossiers

🔹 Coordinate regulatory activities with internal and client teams

🔹 Act as main point of contact with the Ministry of Health and other Competent Authorities

🔹 Monitor regulatory updates and advise on portfolio innovation

🔹 Provide guidance and mentoring to junior team members

Requisite Qualifications and Proficiencies

✅ Scientific degree (Pharmacy, CTF, Biology, Chemistry or similar)

✅ 5+ years of proven experience in Regulatory Affairs, with expertise in at least two of the following: food supplements, FSMPs, homeopathics

✅ In-depth knowledge of EU regulations concerning these fields

✅ Excellent English communication skills (knowledge of Italian and Romanian languages is considered added value)

✅ Strategic mindset, technical leadership, precision and autonomy

Preferred qualifications

⭐ Experience with borderline Medical Devices

⭐ Previous consultancy experience or client-facing roles

⭐ Familiarity with regulatory frameworks in other markets (extra-EU)

What we offer

🌱 Collaboration with a senior, multidisciplinary team

🌍 Involvement in diverse and high-impact EU projects

📈 A growth path tailored to your ambitions and expertise

🧩 Flexible work structure with strong autonomy

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 info@pharmamc.org specifying in the object of the e-mail “Application for Director of Pharmaceutical Import/Export”.

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.