KEY RESPONSIBILITIES:

• Compilation of regulatory dossiers Part 1 – 4 for National (Export Applications) Marketing Authorization (MA) applications in a timely and accurate manner.
• Communication on regular basis with supervisor/ relevant managers to give regular feedback on regulatory status of export applications.
• Review of process validation protocols and reports for inclusion in Part 2.
• Review of assay validation data and stability data to be included in Part 2.
• Review of Drug Master Files
• Writing of Quality Overall Summaries for National MA’s based on European Guidelines.
• Responding to queries raised by the regulatory authorities or customers for new product licenses, renewals and variations in a timely and accurate manner.
• Preparation and submission of renewal applications for existing Marketing Authorizations and doing follow up.
• Preparation and submission of variation applications to existing Marketing Authorizations and doing follow up.
• Artwork review and approval
• Transfer of data from Regulatory Department to internal departments via Post Licensing check lists
• Responding to queries from other departments.
• Keep up to date with changes in global regulatory requirement.
• Ability to work on multiple projects simultaneously.
• Liaise with Regulatory Consultants and provide all the required to do local submissions.
• Get the official documents notarized and legalized as per request.
• Sending on/Arrange sending the required finished product samples, raw material standards and artwork samples (Demo) to customers as per request in companion with the related required documentations.
• Keeping our internal records and databases updated.
• Liaise with API suppliers and contract finished product manufacturers to get documentations specific for local submissions.
• Suggest Trade Names for the local submissions in line with documentations we can offer (according to our Licences in Europe).
• Proceed with Trademark Registrations in some countries according to the local regulations.
• Search scientific databases to get recent scientific published articles as per request.
• Organizing regulatory payments and the recharging of costs to customers in a timely manner.
• Assist departments/affiliated companies/customers in technical queries and discussions.
• Participate in conference calls to provide regulatory advice as required.
• Advise Business Development Department employees upon request on feasibility of entering specific market from regulatory point of view.
• Amend the submitted Periodic Safety Update Reports to EU authorities to pull out any confidential info, such as sales data, and submit within national MA applications.

COMPETENCIES:

• Ability to build relationships and collaborate with others.
• Ability to collaborate cross-functionally and across geographies.
• Ability to work on multiple projects simultaneously, to tight deadlines and on own initiative.
• Good attention to detail.
• Good communication skills both written and orally.
• Good technical knowledge of pharmaceutical products and processes.
• Good customer focus.
  
  
  

QUALIFICATIONS:

• Scientific Qualification and background – preferably B.Sc. or equivalent 
• Minimum 3 – 5 years in a regulatory/R&D environment preferably with experience in generic pharmaceutical applications.
• Good computer skills in MS Office.
• Knowledge of EU GMP, regulatory and pharmacovigilance guidelines.