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!

Legal counsel 100%

RESPONSABILITIES:

The job position includes the following tasks and duties:

  • Drafting and reviewing of a variety of international commercial agreements and other legal documentation (CDA, distribution agreements, supply agreements, license agreements, POA, LOA, etc.);
  • Ensuring the entire follow-up of contracts up to signature;
  • Collaborating with other corporate departments and external counsels;
  • Updating and maintaining contract management IT database;
  • Providing legal analysis and advice on complex contracts, compliance, regulations and/or business issues;
  • Day-to-day Compliance / Corporate social responsibility activities to ensure regulatory compliance and preservation of the company’s interests with business partners which includes implementation, review, drafting and update of compliance policies and procedures, routine compliance checks, conduct staff trainings (e.g. code of conduct), seize opportunities of creating efficiencies and improving processes on all compliance matters, including data protection, corruption / anti-bribery, sanctions regulations ;
  • Assisting in any other legal and compliance matters when requested.

    EDUCATION:

    • Master’s degree in business law or equivalent (legal education in commercial and/or pharmaceutical law);
    • Minimum 2-3 years’ experience in commercial legal practice or compliance (law firm or in-house position), ideally in healthcare or pharmaceutical industry;
    • Knowledge of compliance and data protection (GDPR) regulations is a strong plus.

    QUALIFICATIONS:

    • Fluency in English and French, oral and written;
    • Knowledge of another language an asset;
    • Highly familiar with main IT office and legal tools (MS Office & legal databases);
    • Strong analytical and drafting skills;
    • Well-organized, able to meet tight deadlines and to juggle multiple priorities;
    • Ability to work independently but also within a team;
    • EU citizen or right to work in Switzerland.

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

    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

      CMC Project Manager (6 months contract)

      SUMMARY OF JOB POSITION:

      The CMC Project Manager is responsible for the Chemistry, Manufacturing and Control (CMC) activities and life-cycle management of Stragen pharmaceutical products.

      ACCOUNTABILITIES:

      CMC writing:

      • Prepare and write quality modules (CTD sections of module 2.3 and 3) for worldwide registration and relevant variations in relation with the approved dossiers and lifecycle
      • Answer to quality questions from Heath Agencies during registration procedures
      • Collaborate/or support with Regulatory Affairs department to elaborate the registration strategy anticipating risks and issues
      • Conduct technical-regulatory intelligence

      CMC activities management:

      • Supervise the external partners for CMC sub-contracted activities (CDMOs for Drug Substance (DS) and Drug Product (DP) manufacturing, analytical laboratories, etc.) in accordance with regulations (ICH, FDA, EMA). CMC activities include DS and DP manufacturing process development and validation, scale-up/scale-down, technology transfer, analytical transfers development and validation, DS and DP specifications, stability studies, etc.
      • Liaise in close collaboration with internal stakeholders as well as in partnership with manufacturers/suppliers on a regular basis and ensure good project coordination
      • Ensure the Product Life Cycle Management through the technical management of the post approval CMC changes

      PERSONAL CORE COMPETENCIES:

      • Able to build and maintain good customer / supplier / manufacturer relationship
      • Able to collaborate with a wide range of people, team player
      • Analytical skills, creativity in problem solving, pragmatic
      • Decision making, ready to take initiatives, proactive
      • Keen on working in an international environment within a growing company

      SKILLS:

      • Pharmaceutical development and eCTD skills
      • Good understanding of quality and regulatory issues (Drug substance and Drug Product)
      • Good knowledge of technico-regulatory guidelines (ICH, EMA, FDA)
      • Project management skills
      • Excellent English communication skills, both in written and spoken

      QUALIFICATIONS / PREREQUISITES:

      • PharmD or related scientific university degree with pharmaceutical and industry specialization
      • About 3 years of experience within a pharmaceutical company in management of CMC projects

      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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