Senior Consultant, Regulatory Affairs - MAA

We are recruiting for A Senior Consultant, Regulatory Affairs to focus on our MAA activities in Turkey.

We are looking for Regulatory Affairs experience in Turkey regulatory lifecycle maintenance submissions (variations, renewals…) and post authorization activities.

You will be responsible for: Provision of strategic advice regarding local regulatory requirements to an internal or external stakeholders Impact Assessment of CMC and labelling Change Controls and/or CCDS Module 1 documents preparation Review of labelling and Artwork in local language (Turkish) Core packages adaptation to local requirements Update of section 1 (country specific) for PBRERs Review of final published submission package Package Submission to Health Authority (includes Requests for Information) Updates to local compendia/HA websites Liaison with Local Country Offices (client) Liaison with internal Global Regulatory Affairs team Liaison with Health Authority Translation ≤1000 words (cover letter/application form/letter from Health Authority…) Qualifications- Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred

- Extensive years of experience in a CRO or industry-related environment; experience with a regulatory agency (such as FDA, MHRA) is a plus

- High-level consulting skills

- Critical thinking and problem-solving skills

- Project leadership and management knowledge

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

- Client-focused approach to work

- Results orientation

- Teamwork and collaboration skills

- Proficiency in local language and extensive working knowledge of the English language

If this sounds like you we encourage you to apply! We will reward you with a competitive salary and benefits package!