/ L'annuaire des offres d'emploi en Suisse Romande

Regulatory Affairs CMC Associate / Manager (Temp contract)

Kelly Services
Date de publication


Kelly Scientific is seeking a Regulatory Affairs CMC Associate / Manager (Temporary contract till December 2018) for my pharmaceutical partner localised in the French part of Switzerland.

This temporary position reports to Global Regulatory Affairs (GRA) CMC and operates in close collaboration with the plant supply organisaton 

Job Purpose: 
•    Responsible for CMC regulatory matters relating to life-cycle maintenance of business activities to handle technical variations for the assigned products portfolio, from evaluation to approval by Health Authorities. 

Key Responsibilities: 
•    Provides CMC evaluations, elaborates regulatory strategy to support potential changes as requested and follows up to ensure regulatory compliance and completion of appropriate internal compliance records e.g. change controls. 
•    Prepares CMC variation documents to update Module 3, collects / prepares necessary additional elements and delivers submission packages for dispatch to company CH affiliates.
•    Implements QbD elements to streamline registered manufacturing details.
•    Interacts permanently with GRA CMC associates and with colleagues in other global functions as needed  and in site functions in particular within Supply chain and QA organisations.
•    Maintains strong links with other Regulatory Affairs sub-functions to deliver high quality CMC dossiers, materials to local Regulatory Affairs in accordance with business priorities and other regulatory activities. 
•    Applies processes and procedures to maintain up-to-date technical product records/information and ensure full traceability of activities.
•    Effectively communicates regulatory technical requirements and guidelines, facilitating timely and complete submissions. 
•    Develops up-to-date knowledge with regard to technical guidelines, regulatory requirements and trends.

Why you? 
Basic qualifications: 
  • Master level degree in a pharmaceutical or life sciences or technical domain with regulatory experience 
  • Good level of scientific / regulatory understanding for medicinal products  
  • Good knowledge of regulations and regulatory guidance, including all applicable ICH guidelines 
  • Good knowledge of pharmaceutical manufacturing and controls operations for liquid and semi solids forms 
  • At last 2 to 3 years’ experience in Regulatory Affairs including CMC 
  • Strategic thinking: the applicant should be able to provide an assessment of the regulatory impact of potentially complex/ multiple changes and to set-up best submission strategies 
  • Fluent in French & English (oral and written)
  • MS Office / Databases / Electronic Document Management Systems 

Preferred qualifications: 
•    Master level degree in a pharmaceutical or life sciences domains with additional regulatory training /certifications

Soft Skills 
- Flexible thinking: structured, creative, conceptual thinker, capable of identifying new solutions and more efficient ways of working, without a continuous improvement mindset 
- Influencing skills & robust stakeholder management: able to build strong relatioships to address transversal need cross the company 
- Able to develop and present strong arguments to maximise probability of success when dealing with Health Authoritiues questions and/ or regulatory challenges
- Strong synthesis and analytical skills, ability to extract key information from complex situations and to simplify
-  Result, value and quality oriented  / excellent writing skills
-  Best in class communicator skills with a relevant agility to work across various functions and with a wide panel of stakeholders at different levels with different cultrures
-  Can work with limited supervision: autonomous and strong sense of priorities 

If you think your profile fits to this position, don't hesitate to apply online, it will be a pleasure for us to consider your interest.

Your contact at Kelly Scientific:
Mathilde DROMARD
PhD in Biology and Health
Consultant Professional Staffing Life Science and Deputy Manager