Regulatory Affairs Consultant CMC

We are recruiting for an experienced Regulatory Affairs Consultant in Romania, to join our CMC Regulatory Team.

If you have Proven Regulatory Delivery Experience in CMC (5 years or more) we would like to hear from you!

Responsibilities: CMC SME/Extensive experience of CMC lifecycle maintenance activities across EU and ROW market Change Control assessment experience (application of relevant regulatory guidance to proposed change) CMC Submission experience of Simple (Type I) and complex variations (Type II) to EU markets in the CP, MRP and National procedures. Experience working on simple and complex APAC and LATAM submissions would be of benefit. Capable of participating in discussion on regulatory strategies with a wide stakeholder network (QA, Brand Leads etc.) ‘Proactive’ and ‘efficient working method Strict adherence to timelines (both internal and HA deadlines) Qualifications• Several years of experience in CMC/ Regulatory position for a CRO

• Project management knowledge

• Excellent interpersonal and intercultural communication skills, both written and verbal

• Client-focused approach to work (Quality)

• Results orientation

• Teamwork and collaboration skills

• Consulting skills

• Critical thinking and problem-solving skills

• Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred