CAREERS

Interested in joining our team, check out our job openings

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

Pharmaceutical Development Project Manager

RESPONSABILITIES:

  • Establish the industrial development strategy of the pharmaceutical products: development plan and protocols, budgets and timelines
  • Supervise the Drug Substance and Drug product manufacturers on the development, manufacturing process development and scale-up, analytical methods and validations activities.
  • Liaise in close collaboration with internal stakeholders as well as in partnership with manufacturers/suppliers on a regular basis and ensure good project coordination
  • Provide technical support in case of manufacturing or quality issues, closely link to Quality Assurance and Regulatory Affairs departments
  • Screen, technically assess and select CMC partners (CDMOs for Drug Substance and Drug Product development and manufacturing, QC Laboratories, etc.)
  • Ensure technology transfer management
  • Collaborate/or support with Regulatory Affairs department to elaborate the registration strategy anticipating risks and issues
  • Write and keep up to date the CTD sections of module 2.3 and 3 (& 2.5 in case of bioequivalence studies)
  • Ensure the Product Life Cycle Management and maintenance of approved dossiers through the management of the post approval CMC changes
  • Conduct technical-regulatory intelligence

    SKILLS:

    • Pharmaceutical development and manufacturing skills
    • Project management skills
    • Good understanding of quality and regulatory issues (Drug substance and Drug Product)
    • Ability to keep informed about technico-regulatory guidelines (ICH, EMA, FDA)
    • Excellent English communication skills, both in written and spoken
    • Adept in using MS Office tools (Excel, Word, PowerPoint, etc.)

    QUALIFICATIONS/PREREQUISITES:

    • PharmD, PhD or related scientific university degree with pharmaceutical and industry specialization
    • At least 3 years of experience working in development within a pharmaceutical company or in management of CMC projects with external CDMOs

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

    Temporary Regulatory Affairs Assistant (80%)

    Immediately available

    THE PRELIMINARY RESPONSABILITIES INCLUDE:
    • Preparation, submission, follow-up and maintenance of marketing authorization applications for assigned products and territories.
    • Preparation of the administrative sections (Module 1).
    • Compilation of dossiers using document and submission management tool.
    • Support RA Managers and Head of RA activities.
    • Communicate outside the organisation on behalf of Stragen with National Competent Authorities and Stragen Customers; ensure that relevant information is shared internally.
    • Timely and liable maintenance of internal and external databases.
    • Ensure correctness and grant “approval” of packaging and promotional materials.
    • Continuously challenge work flows and procedures with regard to improvement of personal /team performance.
    • Keep up-to-date with changes in regulatory legislation and guidelines.

     

    EDUCATION & WORK EXPERIENCE:

    • Scientific baccalaureate with at least 2 years of experience in Regulatory Affairs within pharmaceutical industry.

    QUALIFICATIONS/PREREQUISITES:

    • Detail-oriented
    • Well-organised; able to judge on time required to complete a task in order to respect given timelines
    • Strong analytical /problem solving skills
    • Excellent command in written and spoken English
    • Team spirit, strong communication /organisational and interpersonal skills
    • Keen on working in an international environment within a fast growing company
    • Good command with Word and Excel. Experience with document and submission management tool a plus.

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

    Temporary QMS Officer

    The QMS Officer is in charge of the implementation, maintenance and improvement of the Stragen Quality Management System (QMS), in close cooperation with the Senior Quality Systems Manager. His/her main activities are: 

    • Maintain up to date Stragen documentation system.
    • Write and/or review quality-related SOPs and other quality documents.
    • Support the Stragen departments in the drafting of their SOPs.
    • Organise and participate to self-inspections and internal audits, define and follow related action plans.
    • Maintain and follow the Stragen training system, coordinate document acknowledgment and training activities.
    • Perform trainings related to QMS topics.
    • Define the annual planning of internal tests (e.g. mock recalls, RTI).
    • Coordinate and perform some internal tests within Stragen, write internal tests reports and follow the related action plans.
    • Support Stragen departments in the implementation of CAPAs.
    • Follow CAPAs related to the Stragen QMS.
    • Prepare and present QA KPIs.
    • Prepare the Annual Quality Management Review (compilation of data, analysis, trending).
    • Perform regulatory survey and literature review.
    • Support Stragen departments and affiliates in the preparation of inspections / audits of Stragen by customer and health Authority.
    • Act as a local contact point for the pharmacovigilance subcontractor

     

    YOUR QUALIFICATIONS:

    • Scientific or Quality University Degree
    • At least 3 years of experience in Quality Assurance within pharmaceutical or biotechnology industries, in a similar position
    • Strong problem identification and problem resolution skills
    • Multitasking,
    • Excellent organizational skills, careful planning to achieve accurate and timely results
    • Good oral and written communication skills
    • Focus on quality and detail
    • Able to prioritize, assess urgency and set deadlines
    • Able to establish collaborative relationships
    • Able to demonstrate excellent listening skills
    • Able to understand technical data and internal processes
    • Tactful & diplomatic
    • Good command with Word and Excel. Experience with document and submission management tool a plus.

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

    Regulatory Affairs Manager 100%

    JOB POSITION:

    The Regulatory Affairs Manager manages and coordinates worldwide registration of dedicated generic 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.

    A real partnership exists with Regulatory Affairs Specialist located in HQ and affiliates and the other departments (e.g. pharmacovigilance, development, business development…). External contacts include the clients of Stragen (distributors and customers) and the external third-parties such as Health Authorities, consultant, contract manufacturers.

    RESPONSIBILITIES:

    The job position includes the following tasks and duties:
    • Management and coordination of worldwide registration of dedicated 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 requirements

    EDUCATION/WORK EXPERIENCE:

    • Pharmacist or Master degree in sciences
    • At least 5 years of experience in Regulatory Affairs in a pharmaceutical industry
    • Effective experience in European procedures (DCP/MRP)
    • Project management experience
    • Experience in CMC an asset

    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 a multicultural environment
    • Experience with document and submission management tool, a plus.

    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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