REGULATORY DOCUMENTATION & COMPLIANCE MANAGER

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 Regulatory Affairs Division in Lugano we are looking for a:

REGULATORY DOCUMENTATION & COMPLIANCE MANAGER

Responsibilities include:

  • Lead and/or collaborate in the implementation, migration, and upgrade of regulatory

    systems and tools (eDMS, Regulatory Information System, CTD templates, etc.)

  • Perform document management tasks including file transfer, storage, tracking, and archival

    of Regulatory submission documentation

  • Collaborate with all Regulatory Affairs (HHC, HBP, HTU) and contributing functional areas

    to create submission project plans as well as identify and allocate internal and external

    resources (including vendors/CROs)

  • Develop and administer in-house training, according to Regulatory and submission project

    team needs. Training includes authoring templates, processes and tools critical to

    compiling all submission types

  • Participate in the writing, reviewing and approving of Regulatory processes (SOP, Work

    Instructions and internal guidelines)

  • Apply company style guide formatting requirements to create submission ready documents

    that are compliant with internal and heath agency requirements

  • Provides regulatory operations guidance and information to Regulatory Affairs department

    and submission project teams

  • Assists in the mentoring and training of Regulatory and cross-functional team members

  • Prepares and maintains training material and leads large and/or complex submission project as well as other projects as assigned by management to support all function at global level, including leading efforts associated with submission management and submission compilation

The successful candidate has the following qualifications:

  • Pharmacy/Pharmaceutical Technology graduated

  • Minimum 8 years related experience in publishing and/or Regulatory Systems role within the

    pharmaceutical industry

  • Minimum 4 years direct people management/supervisory experience required

  • IT skills and specific training and course in new trends (e-CTD) of regulatory affairs and

    documentation management

  • Independent and proactive with capacity of problem solving, and with persuasive attitude

  • Demonstrate strong analytical and communication skills

  • Ability to work effectively both individually and as part of a team

  • Experience in implementing Regulatory system preferred

 

Helsinn Healthcare SA is offering attractive conditions, a pleasant working environment in a highly motivated team and a long-term perspective.

Please send relevant application with CV to:

http:// helsinn.jobopportunity.ch