Regulatory Affairs Officer

2 days ago

Marousi, Attica, Greece Pharmathen Full time €25,000 - €40,000 per year

Founded in 1969, Pharmathen has grown to become one of the largest, vertically integrated developers of complex drug delivery technologies and is among the top 50 pharmaceutical research companies in Europe.

The company has one of the most extensive and advanced pipelines of long acting injectables (LAI), sustained release and ophthalmic formulations.

Pharmathen's highly diversified portfolio consists of over 90 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 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.

Due to continuous growth and expansion, Pharmathen Pharmaceuticals offers a great opportunity for career development and is seeking to attract a Regulatory Affairs Officer to join our Regulatory Affairs team at Pharmathen's Marousipremises.

As a Regulatory Affairs Officer you will be responsible for submitting applications for marketing authorizations and for lifecycle management of the MAs (renewals/variations). You will also act as a liaison person with regulatory authorities/clients.

More particularly:

What you'll do:

  • Keep abreast of international legislation, guidelines and customer practices
  • Collect and collate a wide range of product information and ensure compliance with all relevant guidelines
  • Be responsible for preparation (module 1) and  coordination/submission of Deficiency Letter (DL) responses
  • Submit new marketing, variation, and renewal applications to authorities within strict deadlines
  • Negotiate with regulatory authorities for marketing authorization
  • Participate in teleconferences and/or meetings with the regulatory authorities, suppliers, clients
  • Follow up of applications and maintenance of relevant databases
Requirements

The ideal candidate should have:

  • Minimum of a Bachelor's Degree in a scientific discipline (preferably Chemical Sciences, or Biochemistry)
  • 2-3 years relevant experience in the pharmaceutical area

Job-Specific Skills:

  • Excellent communication in English language (writing & speaking)
  • Computer literacy
  • Multi-tasking
  • Time management
  • Ability to prioritize work and meet deadlines
Benefits

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.

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