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.
- 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.
- 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