CAREERS

Interested in joining our team, check out our job openings

We are a global player in the development, registration and distribution of generics, consumer health products and original drugs. We are continuously looking for new talent to join our team of passionate people committed to bringing innovation to public health. Make an impact!

Regulatory Affairs Manager (100%)

JOB POSITION

The Regulatory Affairs Manager manages and coordinates worldwide registration of dedicated products from initial Marketing Authorization Applications over life cycle. The Regulatory Affairs Manager works in close collaboration with internal and external resources and reports to the Head of Regulatory Affairs.

 

RESPONSIBILITIES

The job position includes the following tasks and duties:

  • Management and coordination of worldwide registration of dedicated generic products from initial Marketing Authorization Applications over life-cycle
  • Define regulatory strategies
  • Accountable for all information presented in module 1 and dossier compilations
  • Interact with other departments, customers, manufacturers and experts to obtain required documentation and materials in duly-time
  • Ensure that deadlines are respected by preventing and identifying issues that may delay submission / approval
  • Reply to Health authorities regulatory deficiencies
  • Follow-on post approval activities (variations, renewal…) within the required timelines and in accordance with the regulatory requirements

In addition:

  • Communicate outside the organization on behalf of the company with Health Authorities and Customers; ensure that relevant information is shared internally.
  • Represent the regulatory function in project teams
  • Responsible for correctness and “approval” of packaging and promotional materials
  • Accountable for timely and liable maintenance of internal and external databases.
  • Ensure submission process and standards adhere to internal SOPs
  • Continuously challenge workflows and procedures with regard to improvement of personal /team performance.
  • Maintain awareness of current and new regulatory legislation/guidance and ensure compliance with these requirement

EDUCATION / WORK EXPERIENCE

  • Pharmacist or equivalent scientific degree
  • At least 5 years of experience in Regulatory Affairs in a pharmaceutical industry
  • Effective project management experience
  • Experience in CMC an asset
  • Previous experience in people management

SKILLS & QUALIFICATIONS

  • Well-organized; able to judge on time required to complete a task in order to respect given timelines
  • Strong analytical /problem solving skills
  • Fluent in English
  • Detail-oriented
  • Team spirit, strong communication /organizational and interpersonal skills
  • Keen on working in an international environment within a fast growing company
  • Able to work in an multicultural environment
  • Experience with document and submission management tool, an asset

 

Interested in a new challenge, please send your full application (cover letter, CV, work certificates) to rh@stragen.ch

Supply Chain & Serialization Specialist (100%)

JOB POSITION

As part of a Global Supply Chain Management Organization you will be responsible for following tasks:

 

RESPONSIBILITIES

  • Maintain and build relationships with customers and manufacturing sites (CMOs)
  • Act as primary contact for the assigned customers, and CMOs
  • Receive, analyse and process forecasts and place orders corresponding to manufacturing service and quarterly communicate forecast to CMOs and Active Ingredients suppliers
  • Manage inventory and deliveries and follow the stock & stock coverage of Stragen Group
  • Support new product introductions
  • Ensure supply to end customers and develop processes that ensure that this supply is protected
  • Handle transport orders in respect of agreed Incoterm, and optimize transportation flows
  • Follow CMOs and forwarder agents performance through KPIs.
  • Manage and proactively resolve supply issues via effective coordination and communication in close cooperation with technical and Sales teams, manufacturing sites and the customers
  • Mitigate and avoid future supply issues by thorough root cause analysis and implementation of preventative measures
  • Comply with all local regulations, Good Distribution Practices, guidelines and procedures
  • Manage the stocks and procurement of each raw material (APIs, excipient and/or packaging element).
  • Keep updated all data in ERP (Sage X3) related to Supply Chain and manage inventory
  • Closely work with Finance department for closing period and understand link with VAT Declaration.
  • Manage serialization activities:
    • On-Boarding for new partners on Tracelink
    • Root cause analysis and implementation corrective actions
    • Relationship with Tracelink and manage serialization implementation for new territories

 

EDUCATION / WORK EXPERIENCE

  • A logistics/supply chain-related university degree or professional diploma
  • 5 years in a logistics/supply chain//order management support function in an international environment, ideally in Pharmaceutical Industry including 2 years for serialization
  • APICS certification
  • Has excellent English communication skills, both in written and spoken
  • Adept in using MS Office tools, especially Excel, and also ERP system (ideally Sage X3)
  • Expertise in serialization and perfect use of IT Solution Tracelink
  • Excellent knowledge of incoterms, customs and transportation documents
  • Flexible approach to negotiating and a willingness to be able to work to time sensitive deadlines
  • Ability to establish and maintain strong professional relationships with Customers as well as with providers
  • Ability to take decisions quickly with good judgment
  • Organized, efficient and proactive
  • Highly motivated and positive attitude
  • Quality and Customer oriented
  • Creativity in problem solving skills and troubleshooting
  • Good analytical skills with ability to manage multiple tasks simultaneously

 

Interested in a new challenge, please send your full application (cover letter, CV, work certificates) to rh@stragen.ch

SPONTANEOUS APPLICATION

You can directly send us a message.

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