Regulatory Affairs CMC

Regulatory Affairs CMC Job Offer

Regulatory Affairs CMC

Are you passionate about CMC in regulatory affairs? Are you willing to learn and develop?

Do you want to apply your knowledge in health sciences and RRAA in a dynamic and international team?

We’re excited to consider you for this position at Asphalion.

 

Main responsibilities:

  • Overall management of Regulatory Activities in different regions and procedures worldwide (EU, US, RoW):
    • New registrations
    • Life-cycle management
    • Support in CMC / quality
    • Regulatory strategy and assessment in development
    • Authoring of regulatory documentation
    • Critical revision of regulatory documentation
  • Responsible person for specific client
  • Responsible person for communication with authorities
  • Responsible for achieving deadlines and overall quality of the work to ensure the best client satisfaction
  • Preparation of team-related trainings both internal and external
  • Support in business development and marketing activities
  • Establish processes and work instructions

According to the project the applicable activities can be done for medicinal products, medical devices, cosmetics, biocides, and other regulated products

We offer you:

  • A highly professional, dynamic, ambitious & international working environment with flat hierarchies and short decision paths. More than 12 nationalities!
  • A great company culture built around Passion, Flexibility, Commitment, Quality & Companionship
  • Training and personal development program.
  • An organization with highly professional people to develop with.
  • A position with challenging tasks and flexible working schedule.
  • Social Benefits.

Requirements

  • Experience in CMC in Regulatory Affairs in Pharmacy Industry it’s required.
  • Background in Health Sciences.
  • Knowledge of Microsoft Office.
  • Good analytical, quality orientation and customer focus skills.
  • High level of English and Spanish
  • High willingness to learn and take on new challenges and responsibilities
  • A team player with good communication skills
  • The ability to handle multiple tasks in a fast paced environment
  • Truckloads of motivation, positivity and enthusiasm

 

Send us your CV today or apply here: https://lnkd.in/gEtUky9

Regulatory Affairs Officer
CLOSED - Regulatory Affairs Officer - CMC Expert

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