Job Description

We are recruiting for A Senior Associate, 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!Why Work at Parexel

There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.