Municipality of Metamorfosi, Attica, Greece · On-site
Senior
Founded in 1969, Pharmathen has grown into a leading developer and manufacturer of specialized pharmaceutical products and one of the largest vertically integrated companies in advanced drug delivery technologies. With a…
Municipality of Metamorfosi, Attica, Greece · On-site
Mid level
Founded in 1969, Pharmathen has grown into a leading developer and manufacturer of specialized pharmaceutical products and one of the largest vertically integrated companies in advanced drug delivery technologies. With a…
Skills: English Communication, Problem-solving, MS Office, SAP, Laboratory Instrumentation
Municipality of Metamorfosi, Attica, Greece · On-site
Entry level
Περιγραφή εταιρείας About Eurofins Scientific Eurofins Scientific is a global leader in bio-analytical testing, providing a broad portfolio of analytical services that support safety, quality, and sustainability across m…
Skills: ICP-MS, Sample Preparation, ISO 17025, Quantitative Determination, Quality Control
Municipality of Metamorfosi, Attica, Greece · On-site
Entry level
Περιγραφή εταιρείας About Eurofins Scientific Eurofins Scientific is a global leader in bio-analytical testing, providing a broad portfolio of analytical services that support safety, quality, and sustainability across m…
Skills: ICP-MS, Sample Preparation, Quantitative Determination of Metals, ISO 17025, Quality Control
Municipality of Metamorfosi, Attica, Greece · On-site
Entry level
Περιγραφή εταιρείας About Eurofins Scientific Eurofins Scientific is a global leader in bio-analytical testing, providing a broad portfolio of analytical services that support safety, quality, and sustainability across m…
Skills: ICP-MS, Sample Preparation, ISO 17025, Quantitative Determination, Quality Control
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Full-time
bachelor degree
Posted 16d ago
~40 hrs/week
Responsibilities
The specialist supports pre- and post-approval CMC activities, including compiling product dossiers and preparing quality variation packages. They act as a liaison between internal departments, suppliers, and regulatory authorities to ensure compliance with international legislation.
Requirements
Candidates must have a bachelor's degree in a scientific discipline and 5-7 years of relevant pharmaceutical experience. Proficiency in English and experience with analytical chemistry, specifically HPLC, are highly valued.
Full job description
Founded in 1969, Pharmathen has grown into a leading developer and manufacturer of specialized pharmaceutical products and one of the largest vertically integrated companies in advanced drug delivery technologies. With a strong international presence, we remain committed to improving people’s lives through innovation and access to affordable, high-quality medicines. Today, our products reach patients in more than 90 countries worldwide, supporting better health outcomes every day.
Pharmathen employs more than 1,600 people from over 27 different nationalities, reflecting a diverse and international workforce. Our achievements are driven by strong scientific expertise, high ethical standards, and the dedication of our people, who share a commitment to improving patient lives.
Pharmathen offers a great opportunity for career development and is seeking to recruit a CMC Regulatory Compliance Specialist to join our R&D team at our Metamorfosi premises.
As a CMC Regulatory Compliance Specialist, the ideal candidate will be responsible for supporting all pre- and post- approval CMC activities and acts as a liaison person with all relevant departments within Pharmathen as well as suppliers.
What you will do:
More particularly:
Keeps abreast of international legislation, regulatory guidelines, and customer requirements.
Collects and collates a wide range of product technical information and ensures compliance with all applicable quality and regulatory guidelines.
Supports all pre-approval CMC activities by compiling product dossiers, including preparing and reviewing Modules 2 and 3, compiling Modules 4 and 5, and responding to Deficiency Letters (DLs) within established timelines.
Supports post-approval CMC activities by preparing quality variation packages and renewals for DCPs, MRPs, CPs, and national applications, and by responding to relevant Deficiency Letters (DLs) within strict deadlines.
Participates in teleconferences and meetings with regulatory authorities, suppliers, clients, and internal stakeholders across the organization.
Actively participates, where relevant, in new product development and lifecycle management activities, including registered product variation strategy assessments, to ensure ongoing regulatory compliance.
The ideal candidate should have:
Minimum of a bachelor’s degree in a scientific discipline (preferably Chemical Sciences, or Biochemistry)
5-7 years relevant experience in the pharmaceutical area
Experience in analytical chemistry (e.g. HPLC) is considered an asset
Job-Specific Skills:
Excellent communication in English language (writing & speaking)
Ability to prioritize tasks and meet deadlines
Computer literacy
Project management
Multi-tasking
Time management
What you'll gain:
Involvement in a high-caliber, team-oriented and dynamic atmosphere
Exposure to challenging business issues and practices
Great opportunity to leverage and develop your business knowledge and skills
Join our team and experience the unique Pharmathen’s culture that gives you the opportunity to innovate, to make decisions, to achieve your own potential and to chart your own career.
Pharmathen is an equal opportunity employer. We welcome applications regardless of gender, race, age, religion, sexual orientation, and national origin.
Founded in 1969, Pharmathen has grown to become one of the largest, vertically integrated developers of complex drug delivery technologies.
Pharmathen is committed to its vision to improve people’s lives through innovation and access to affordable medicines.
The company has one of the most extensive and advanced pipelines in the industry, with a focus on long acting injectables (LAI), sustained release and ophthalmic formulations. Pharmathen’s highly diversified portfolio consists of over 100 commercialized products, which are produced in its US FDA and EU-approved manufacturing facilities in Greece, serving 250 customers and accessed by patients in more than 90 countries worldwide.
Pharmathen is constantly strengthening its portfolio with innovative technologies and Long-Acting Therapeutic Technologies (LATTs) and has developed three fully certified technological platforms to achieve this. As a result, Pharmathen can provide a wide range of therapies which aim to improve treatment compliance for patients and support product Life Cycle Management (LCM) opportunities for customers.
Pharmathen maintains a strong presence in all major markets and collaborates with the most significant organizations in the global pharmaceutical market, supported by a broad partner network in more than 90 countries worldwide. The company ranks among the top 50 pharmaceutical research companies in Europe and is one of the largest private sector investors in research and development in Greece.
Pharmathen proudly employs more than 1,600 people from over 28 different nationalities, with 54% of its total workforce and 66% of its Research Operations Team being female. The company's enduring success is attributed to a passion for creativity, strong ethics, and the dedication of its people, who share a commitment to the company's vision of making a difference in people’s lives.
Offices: 44, Kifissias Avenue, Marousi, Attica 15125, GR · Van Heuven Goedhartlaan 9, Amstelveen, North Holland 1181, NL · 8-10, Upper Marlborough Road, Ground Floor Front Suite, St Albans, Hertfordshire AL1 3UR, GB · 118, Al Madeena Al Munawwarah str, Amman, 304 Jad Center, KE
Generic Drugs DevelopmentRegistrationMarketing of Products & Selling of Dossiers etc.Research & DevelopmentManufacturingand PharmaceuticalsHealth CareBiotechnologyMedicalPharmaceutical
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Companies currently hiring include Eurofins Viracor, Pharmathen, among others. Browse the listings above to see every active employer.
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