Senior Specialist, Regulatory Affairs

We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.

##Locations: Noida and Mumbai

Senior Specialist, Regulatory Affairs


Your Job

• Support EU Hub Manager for medicinal products submissions  (new marketing authorization application, renewal, variations, MAH transfer)
  ·    Coordinate with EU local RA team and support Hub Manager for any regional and local EU requests
  ·    Coordination with project teams with internal and external staff and global partners incl. reporting and oversight activities and responsibilities
  ·    Responsible for the planning, filing and prosecution of Regulatory Affairs projects
  ·    Prepare and compilation of the informative texts for healthcare professionals and patients (CCDS, SmPC, PIL, Labeling)
  ·    Update tracking of updates and respective handling of databases and document management systems
   Relevant experience and Qualification :
   Graduate/Master's degree in Pharma (B. Pharm/M.Pharm), Science/Biotechnology (B.Sc/M.Sc),
  Regulatory Affairs experience in a pharma company, preferably including experience in cosmetics, food supplements and/or herbal products
  Experience in EU submission process
   
  Professional Skills and Capabilities
  Knowledge of EU regulatory affairs disciplines
  Knowledge of labelling regulations and guidance
  Excellent verbal and written communication skills
  Attention to detail and accuracy