Regulatory Affairs Expert (permanent contract/ full-time job)

Helsinn is a fully integrated, global biopharma company headquartered in Lugano, Switzerland. It is focused on improving the lives of cancer patients all over the world with a leading position in cancer supportive care and innovative pipeline of cancer therapeutics.

Helsinn is a third-generation family-owned company, that since 1976 has been focused on improving the lives of patients, guided by core values of respect, integrity and quality. It operates a unique licensing business model with integrated drug development and manufacturing capabilities. Helsinn has a commercial presence in 190 countries either directly, with operating subsidiaries in the U.S. and China, or via its network of long-standing trusted partners.

Helsinn plays an active and central role in promoting social transformation in favor of people and the environment. Corporate social responsibility is at the heart of everything we do, which is reinforced in the company’s strategic plan by a commitment to sustainable growth.

To learn more about Helsinn Group please visit www.helsinn.com

 

For our Regulatory Affairs team in Lugano we are looking for a:

 

Regulatory Affairs Expert (permanent contract/ full-time job)

 

Responsibilities include:

 

  • Prepare, review and maintain regulatory applications including marketing authorization applications worldwide, investigational applications (such as Clinical Trial Applications), and other regulatory applications (Orphan Medicines Applications, Paediatric Investigational Plans, Scientific Advice Requests etc..) together with supervisor and other functions, other Helsinn companies and /or partners/ distributors as appropriate.
  • Collaborate in the preparation of the responses to Health Authority questions together with supervisor and other functions, other Helsinn companies and /or partners/ distributors as appropriate (i.e. clinical trial applications, marketing authorization applications, other regulatory applications). 
  • Support supervisor in organizing meetings and other regulatory interactions with the Competent Authorities worldwide either directly or in collaboration with other Helsinn companies and/or partners/distributors.
  • Manage administrative regulatory functions, such as Clinicaltrial.gov and EudraCT portal, in cooperation with other functions. Maintains regulatory databases.
  • Plan, execute and coordinate all the regulatory activities required for the life cycle management of the medicinal products such as variations, renewals, follow-up, routine requests from the Competent Authorities either directly or in collaboration with other Helsinn companies and/or partners/distributors. 
  • Coordinate, prepare, review and approve the product information, such as labels, leaflets, SmPC, packaging materials for the launch and during life cycle of the medicinal products.
  • Review and approve the promotional material for the approved medicinal products worldwide.
  • Prepare and review SOP’s as appropriate.
  • Work closely with supervisor, CROs and consultants.

 

The successful candidate has the following qualifications:

 

  • At least 3 years in a Regulatory Affairs Manager role at Corporate level (HQ) of a Multinational Ethical Pharmaceutical Company or at least 5 years in a Regulatory role within a CRO including working knowledge of the ICH regulations (preferably US, EU) and the publishing systems for electronic submissions (eCTD)
  • University Degree in Health Sciences i.e. Pharmacist by qualification (Pharm.D) or PhD in pharmaceutical Science, MSc Biology
  • High level of English knowledge, interpersonal and written communication.
  • Writing skills.
  • Flexibility, autonomy, and high level of initiative.
  • Team-oriented personality.
  • Standard skills as those expected from a regulatory experienced professional.
  • Some travel is required

 

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