REGULATORY DOCUMENTATION & COMPLIANCE SPECIALIST

Helsinn is a privately owned pharmaceutical group with an extensive portfolio of marketed cancer care products and a robust drug development pipeline. Since 1976, Helsinn has been improving the everyday lives of patients, guided by core family values of respect, integrity and quality. The Group works across pharmaceuticals, biotechnology, medical devices and nutritional supplements and has expertise in research, development, manufacture and the commercialization of therapeutic and supportive care products for cancer, pain and inflammation and gastroenterology.

In 2016, Helsinn created the Helsinn Investment Fund to support early-stage investment opportunities in areas of unmet patient need. The company is headquartered in Lugano, Switzerland, with operating subsidiaries in Switzerland, Ireland, the U.S., Monaco, and China, as well as a product presence in approximately 190 countries globally.

For our Scientific Operations Division in Lugano we are looking for a:

REGULATORY DOCUMENTATION & COMPLIANCE SPECIALIST

Responsibilities include:

  • Support the Regulatory Department in the new product registration procedure, document preparation and e-submission.
  • General support to the eSubmission and documentation management procedure (document formatting, dossier creation, submission validation, etc. to ensure eCTD compliance).
  • Publish documents for electronic submissions in eCTD format
  • Managing the submission of eCTD dossiers through the relevant gateway/portal (e.g. EMA / FDA Submissions Gateway)
  • Provide appropriate training to global regulatory professionals on eCTD publishing processes and technology requirements in the preparation, publishing and life-cycle management of electronic submissions.
  • Provide appropriate training to global regulatory professionals on Electronic Document Management System (EDMS).
  • Participate in projects related to the work of Regulatory Operations.
  • Provide input to quality system documents related to the work of Regulatory Operations.
  • Prepare or collaborate in the preparation of related SOPs

    The successful candidate has the following qualifications:

  • At least 3+ years of experience in Life Science / Pharmaceutical Sector - Regulatory Affairs Field
  • Pharmacy/Pharmaceutical Technology graduated. Life science  with additional training in IT areas, or IT professional with experience in the Life Science / Pharmaceutical Sector - Regulatory Affairs Field
  • Profound understanding of eCTD regulatory guidance in the EU and US and knowledge in Dossier e-Submission
  • Knowledge in Documentation Life Cycle and Good Documentation Practices
  • Knowledge of eCTD Manager software as an advantage
  • Strong knowledge of Microsoft Office and Adobe
  • Familiarity with GMP regulations and relevant record management
  • Open-minded personality with strong knowledge in Dossier e-Submission
  • Attention to details, flexibility
  • Ability to interact with other people, internally and at customer site, with different attitudes, but always in a kind, professional an polite way
  • Strong written, oral & presentation skills, good communication skills
  • English language proficiency
  • Ability to work under pressure and stress and to convince the team to do as well for the common goal of the project
  • Some travel needed

 

Helsinn Healthcare SA is offering attractive conditions and a pleasant working environment in a highly motivated team.

Please send relevant application with CV to:

http:// helsinn.jobopportunity.ch