Regulatory Affairs Project Manager

ELC Group, s.r.o.

Industry: Project, Program Management

City: Yerevan

Employment type: Full time

Deadline: 3/6/2021

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.

The position is remote, you will be able to work from home as a contractor, with a regular 8 hours/day schedule. If interested, please visit our website: www.elc-group.com/careers and apply from there.

KEY RESPONSIBILITIES:

Regulatory Affairs Project Manager

  • 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
  • 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.

IDEAL CANDIDATE

Regulatory Affairs Project Manager

  • 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.
  • A 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.

Interested and matching candidates are requested to send their CVs to the mentioned email.

 

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