Senior Regulatory Affairs Associate - Home based (Turkiye)

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

About Parexel

Parexel is a leading global clinical development partner delivering insights driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose, moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry leading innovation, With Heart®.

About the Role

We are seeking an experienced Senior Local Regulatory Specialist/Associate based in Türkiye to support one of our key sponsors. This role is central to ensuring successful regulatory operations within local markets, serving as a critical link between health authorities, commercial teams, regulatory stakeholders, and regional regulatory functions. This role will involve in person meetings with the relevant Health Authority representatives.

You will play an important role in supporting product registrations, lifecycle management activities, regulatory compliance, and health authority engagement while helping bring and maintain important therapies for patients.

Key Responsibilities

·         Provide local regulatory input to support the development and execution of regulatory strategies for new product registrations and lifecycle management activities while monitoring and communicating progress to stakeholders.

·         Ensure compliance with local regulatory requirements and participate in policy related activities with industry groups and trade associations.

·         Maintain current knowledge of local regulatory requirements, guidelines, and industry developments and communicate relevant changes and requirements to stakeholders.

·         Support interactions with internal and external stakeholders, including health authorities, partners, vendors, and commercial colleagues, while representing regulatory interests effectively.

·         Prepare, organize, and coordinate local regulatory documentation, including country specific submission components and maintenance of local regulatory systems in accordance with legislation.

·         Support implementation of local legislation, interpretation of regulations, promotional material review activities, and operational regulatory execution.

·         Partner with regional regulatory teams to support planning, preparation, and execution of regulatory submissions in line with local requirements and business priorities.

·         Act as the regulatory representative for local commercial operations by supporting lifecycle management activities and communicating regulatory approvals.

·         Maintain regulatory information management systems and monitor compliance activities to support timely renewals, post approval submissions, and regulatory commitments.

·         Support compliant labeling activities, including updates, translations, and promotional material review in partnership with relevant stakeholders.

Candidate Profile

You’ll thrive in this role if you bring:

·         Strong expertise in local regulatory affairs, health authority engagement, and regulatory compliance

·         Experience managing regulatory submissions, timelines, and cross functional collaboration in a regulated environment

·         The ability to build effective relationships with internal and external stakeholders

·         A proactive approach to problem solving, prioritization, and regulatory risk management

·         Comfort working with regulatory information management systems, documentation processes, and global matrix teams

·         The ability to remain effective in a fast changing environment while maintaining a high level of quality and compliance

Required Qualifications

·         Relevant bachelor's degree or equivalent secondary education in a scientific discipline such as biology, chemistry, or a related field with a pharmacological focus

·         5+ years of Turkish regulatory experience in a health authority facing regulatory affairs role

·         Strong understanding of regional and global regulatory requirements, guidelines, and regulatory processes

·         Experience managing regulatory submissions, timelines, and cross functional activities to support successful product registrations and compliance objectives

·         In depth expertise in local health authority engagement and management

·         Strong communication, organization, time management, and problem solving skills within a global environment

·         Fluent in the local language and English, both written and verbal

·         Advanced Microsoft Office skills

Preferred Qualifications

·         Regulatory Affairs Certification relevant to the region, such as RAC, CARP, or CHPC

·         Experience operating within complex global matrix organizations

·         Demonstrated success navigating changing regulatory environments and evolving business priorities

·         Proven ability to work independently while contributing effectively to team objectives

Benefits and Compensation

·         Health, Vision & Dental Insurance

·         Vacation/Holiday/Sick Time

·         Flexible benefit portal

If this job doesn’t sound like the next step in your career, but perhaps you know of someone who’d be a perfect fit, send them the link to apply!

We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.