Regulatory Expert

Pharmathen

Αθήνα
Μόνιμη
Πλήρης Απασχόληση

Πριν 23 ημέρες
Κάντε αίτηση εύκολα

Pharmathen is one of the leading complex drug delivery and formulation developers and is among the top 50 pharmaceutical research companies in Europe. Driven by innovation, the company specializes in one of the most modern and technologically innovative sectors, developing Long Acting Injectables (LAI), Sustained Release formulations and Preservative Free Ophthalmics.Pharmathen’s portfolio consists of over 100 products, produced at its facility in Sapes, Rodopi, approved by the US Food and Drug Administration (FDA), and at its modernized production unit in Pallini, Attica.Pharmathen is one of the largest private investors in research and development in Greece, with steady investments of €35 million annually in the R&D sector and employs over 1,350 people from over 24 different nationalities. The company's enduring success is attributed to the passion for creativity, the ethics, and dedication of its people, who share the company's vision of making a difference in people’s lives.Due to continuous growth and expansion, Pharmathen Pharmaceuticals offers a great opportunity for career development and is seeking to attract a Regulatory Expert to join our Research & Development Operations team at Pharmathen’s Metamorfosi premises.As a Regulatory Expert you will support for US business from regulatory/ CMC/ compliance perspective.More particularly:What you’ll do:

Support any and all regulatory/ CMC/ compliance related activities for the US market
Compile US dossiers as per the agreements with customers
Draft correspondence for the FDA as needed
Assess change plan to support R&D and commercial activities
Support R&D with relevant strategies for development of a robust approvable commercial product
Interact with clients/ customers and provide solutions to complex regulatory/ CMC matters
Provide solutions to commercial from a RA/ CMC perspective for continuous supply
Support QA in various risk assessments and/ or justifications as needed
Be updated with any new US FDA guidance documents and train other colleagues

RequirementsThe ideal candidate should have:

Master’s degree or PhD in Pharmacy, Chemistry, Chemical Engineering, or related field
7 – 10 years of experience in regulatory affairs with a focus on CMC for pharmaceutical products

Job-Specific Skills:

Proficient with MS word and other computer skills
In-depth knowledge of global regulatory requirements and guidelines related to CMC aspects
Strong understanding of pharmaceutical manufacturing processes, analytical methods, and quality control principles
Proficiency in interpreting and applying regulatory requirements to product development and manufacturing activities
Excellent communication skills, with the ability to articulate complex technical concepts clearly and concisely
Strong analytical and problem-solving abilities, with attention to detail and accuracy
Effective project management skills, including the ability to prioritize tasks and meet deadlines in a fast-paced environment
Proven ability to work collaboratively in cross-functional teams and influence decision-making
Adaptability and willingness to embrace change in a dynamic regulatory landscape
Excellent communication in English language (writing & speaking)

BenefitsWhat 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.

Pharmathen