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