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Our client is an international pharmaceutical company based in Basel. For a long therm temporary assignment we are looking for a
Technical Regulatory Team Member
In this role you are contributing to the development and execution of regulatory strategies, the sustainment of regulatory compliance at manufacturing sites, and the representation of PTR within internal functions and external groups. The focus of the TRT is on enabling global CMC-development leading to successful global commercial registration and/or effective management of post-approvals changes and product lifecycle including dossier preparation.
- 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 our 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, health authority inspections, discrepancy assessments)
- 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
- Master’s Degree in life science disciplines is preferred; Post Graduate Degree is a plus. Bachelor’s Degree in pharmaceutical industry is also appropriate.
- 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.
- 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).
- 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.
- Strong verbal and written communication skills.
- Fluent in English, if applicable additional language spoken in the region of responsibility.
- Ability to travel according to the needs of the program
If you are motivated and have good communication skills please send your CV including letters of reference by E-Mail to email@example.com
ELAN Personal AG
CH 4053 Basel
Tel. 061 336 33 33