Director of Pharmaceutical Import/Export

Location: Full Remote

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

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:

Director of Pharmaceutical Import/Export shall bear ultimate responsibility for the strategic superintendence and executive direction of all facets appertaining to PMC clients' international trade activities.

This senior-level appointment necessitates the meticulous formulation and rigorous implementation of strategic frameworks designed to ensure the efficient, compliant and economically judicious execution of import and export processes.

Furthermore, he/she encompasses the proficient administration of a dedicated personnel and the unwavering adherence to all relevant regulatory requirements.

A strategic and extensively experienced person of distinguished leadership caliber is hereby sought to integrate within the existing organisational framework and to assume comprehensive oversight of global pharmaceutical importation and exportation operations.

PMC will provide this position with leadership, mentoring and professional development, promoting an ethos of superlative performance and continuous improvement.

Principal Responsibilities:

· Provide strategic and operational support to clients for compliance with pharmaceutical import/export applicable legislation.

· Assist in the preparation of documentation required for import and export licences and customs authorisations.

· Manage procedures for controlled substances (e.g. psychotropics, narcotics) in accordance with national and international applicable legislation.

· Support clients in planning global logistics and distribution activities, with a focus on cold chain and transport requirements.

· Interfacing with logistics providers, international freight forwarders, customs brokers Competent Authorities.

· Draw up and verify: proforma invoices, packing lists, health certificates, declarations of conformity, CoA, letters of authorisation.

· Support audits and inspections related to import/export activities.

· Coordinating complex projects for international clients in the pharma and Medical Device sector, acting as a technical and regulatory contact.

· Offer customised solutions for commercial expansion into new markets (e.g. customs dossiers, licence applications, local regulatory analyses).

· Provide risk analysis and regulatory/commercial opportunities related to import/export routes.

· Advise clients on alternative supply chain management scenarios, taking into account local regulations, cost and time.

Requisite Qualifications and Proficiencies:

· Degree in Pharmacy, Chemistry, Biology, Biotechnology, or similar; Economics or Management Engineering is also accepted, if accompanied by specific pharmaceutical experience.

• Possible post-graduate masters in Regulatory Affairs, Pharmaceutical Logistics, International Affairs, etc., are highly valued.
• Knowledge of GDP and GMP.
• Familiarity with national and international applicable regulations and guidelines.
• Knowledge of customs and licensing procedures for restricted substances (e.g. psychotropics, narcotics).
• Ability to read and draft technical and customs documentation (invoice, packing list, health certificates, etc.).

· Skills in logistics supplier qualification processes and audit activities.

· Fluent written and spoken English (minimum level B2, preferably C1), essential for communication with Competent Authorities and partners.

· Good command of IT tools (Excel, ERP, tracking and document management software, e-submission systems).

• At least 3-5 years of experience in regulatory, logistical or commercial work in the pharma or Medical Device sector.
• Direct experience in import/export practice management or consultancy for pharmaceutical companies is also well considered.
• Accuracy and regulatory compliance orientation.
• Ability to work in regulated environments and under deadlines.
• Excellent communication and interaction skills with clients and Competent Authorities.
• Problem solving and independent project management.

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 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.

Job Type: Commission