Publicat 02 Feb 2021 | Expiră 05 Mar 2021

Regulatory Affairs Project Manager

2 posturi
Expirat
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Candidatul ideal

  • Be proficient in written and spoken English; knowledge of other languages is a distinctive advantage.
  • Understand project management principles.
  • Knowledge of Product Life Cycle Management and EU regulations and guidelines is an advantage, experience of eCTD would also be beneficial.
  • University degree or equivalent experience in Life Sciences (Chemistry, Pharmacology, Biology, Medicine, etc.) is an advantage.
  • Be flexible and adaptable to changing project priorities and work assignments.
  • Be able to work under strict timelines.
  • Have excellent communication skills.

Descrierea jobului

Excellent opportunity for fresh graduates!

By joining our international team you will work closely with colleagues from different countries and departments and you will be a key contact person for our clients for new products and compliance-related issues. You will be able to work from home as a contractor, with a regular 8 hours a day schedule.

General Project Management

  • Design and implement project plans by coordinating with other departments as well as with clients to ensure that projects are implemented, deadlines are met and deliverables are of high quality.
  • Identify and report project and deliverable related risks to direct managers or relevant experts.
  • Follow current Standard Operating Procedures (SOP) guidelines regarding procedural steps throughout the entire life cycle of the project.
  • Act as (Single) Point of Contact and oversee clients' portfolios.
Regulatory Affairs
  • Submit registration and maintenance documents to regulatory agencies and carry out all the subsequent negotiations and activities necessary to obtain and maintain the marketing authorization for the products.
  • Work closely with government agencies to ensure all legislation is closely followed and the clients' products comply with the regulations.

Descrierea companiei

ELC GROUP is a fully-fledged global regulatory partner, working with major pharmaceutical stakeholders for over a decade. The company is based in Prague with offices in Romania and India. We are now facing an exciting time with further expansion of the business, leading to a number of opportunities arising to join the ELC GROUP team.

Expirat
Regulatory Affairs Project Manager  -  ELC Group

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