technical regulatory specialist in Basel

posted
contact
Dominik Udovicic, Zurich IT Professionals
job type
temporary
apply now

job details

posted
location
basel, basel-stadt
sector
IT
job type
temporary
reference number
11467
contact
dominik udovicic, zurich it professionals
phone
058 201 56 60
apply now

job description

For one of our clients a global pharma company we are currently looking for a Technical Regulatory Team Member (TRT).

Primary duties and responsibilities:

  • Responsible for submission of high quality CMC regulatory documents to health authorities in accordance with current Good Manufacturing Practices (cGMP), corporate standards and the requirements of applicable health authorities and other regulatory agencies.
  • Contributing to the timely regulatory approval of products.
  • Actively contribute to the success of the technical regulatory team (TRT) objectives.
  • Support the development and communication of the regulatory strategy to ensure cross-functional alignment.
  • Help ensure cross-functional coordination and escalation, as needed.
  • Ensuring cross-functional PTR deliverables (including assignments delegated by TRL) are completed compliantly, accurately, thoroughly and in a high quality and timely manner.
  • Keeping TRL fully apprised of project status and potential submission risks and impact to defined regulatory strategies and timelines.
  • Managing regulatory aspects of change control and ensuring appropriate communication to TRT team regarding management of technical changes. Provide regulatory support for relevant quality systems such as change control, discrepancy management, as well as Health Authority inspection support as required and/or serving as a liaison with the local health authority on behalf of the site.
  • Contributing to regulatory excellence by identifying opportunities, mitigating risks and supporting continuous improvement.
  • Supporting TRT team in making clear decisions.
  • Supporting product related maintenance and Quality System activities as assigned (e.g., health authority commitments
  • Support departmental business processes to document and improve best practices and work efficiencies.
  • Serving as TRL designate or PTR regulatory compliance representative as requested by representing PTR on site, cross-functional, or leadership teams and boards (e.g., TPT/TDT, RAFT, RAC, GEG, QRB, Quality Council, Quality Leadership Team).
  • As applicable: Coordinate submission as Submission Lead or Section Lead

QUALIFICATIONS/ EDUCATION:

  • Master’s Degree in life science disciplines is preferred; Post Graduate Degree is a plus. Bachelor’s Degree in pharmaceutical industry is also appropriate. Experience
  • 3 or more years’ work experience in the pharmaceutical, biotechnology or related industry in CMC, Regulatory, Quality, R&D, Manufacturing, Supply Chain Management or related would be a plus.
  • Experience and effectiveness leading strategic regulatory activities for product development from entry into humans through lifecycle management and marketed products is a plus.
  • International or global work experience is a plus.
  • Experience participating in global product teams is a plus.
  • Experience as a contributor for global filings in the US or Europe is a plus.

Knowledge/Skills/Competencies

  • Demonstrates, or has proven abilities to demonstrate PTR and Core Competencies.
  • Technical Knowledge
    • Knowledge of regulations and guidelines of major regions (e.g. ICH, FDA, EMA, WHO) or access to expert knowledge for other regions.
    • Proficiency with a wide range of data/information (CMC, clinical, non-clinical safety, DMPK, quality, manufacturing, business operations in this area).
  • Business Acumen
    • Knowledge of drug development, commercialization process and Pharmaceutical Quality Systems.
    • Knowledge of multidisciplinary functions involved in drug development (all functions) and/or manufacturing and commercialization.
    • Possesses strategic agility and proficiency in business tools, project management and risk- management principles.
    • Drives for continuous improvements and operate with lean mindset.
  • Collaboration and Leadership
  • Demonstrated ability to work effectively in matrix team environment, while keeping management informed and consulted as needed.
  • Ability to effectively prioritize and manage own work.
  • Influencing and negotiation skills: extracts optimized business results through skillful collaboration with matrix team members without formal authority and is adept at identifying solutions that will meet the needs of all parties involved.
  • Communication
    • Strong verbal and written communication skills.
    • Fluent in English, if applicable additional language spoken in the region of responsibility.

If your profile fits to the job description above then I am looking forward to receive your full application at: dominik.udovicic@randstad.ch or call me: +41 58 201 56 60.