Regulatory Affairs CMC Expert

Love to take new challenges, to work in an international environment and want to grow? This is your opportunity!
Regulatory Affairs Officer Expert CMC with experience within pharmaceutical industry to join our team in Barcelona offices.

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

What we offer:
- Permanent contract.
- Professional development.
- 39hrs/week.
- Social Benefits.
- Tele work.
- Multicultural company. More than 10 nationalities.

Requirements:
- 4 years experience in Regulatory Affairs.
- Solid experience in development,maintenance, variations of modul 3 - CMC.
- Experience in medical products.
- Mandatory: fluent English: writing and speaking.