Regulatory Affairs Consultant - CTA & MAA (home or office based)

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.

We are excited to announce an opportunity for a skilled and experienced Regulatory Affairs professional to join our dynamic and expanding team at Parexel. This role can be either home or office-based in Budapest.

As a Regulatory Affairs Consultant you will come with a few years of Regulatory Affairs experience gained in the industry. You will bring experience from various European locations. You will have a chance to work on submissions for Parexel as well as dedicated for clients. In return we will offer you training and knowledge of the organization’s basic consulting models and methodologies as well as basic knowledge of what services we provide. Under the general direction of a Project Lead and/or Technical SME, you will take responsibility for ensuring that client work is performed, and delivered on time, meeting the quality expectations of the business and the client. We will provide you with support of more senior staff to accomplish more complex tasks. You may act in a client-facing role with clear guidance and support from line management.

Main responsibilities:

• Preparation, submission and maintenance of Clinical Trial Applications (CTAs) acting as Local Regulatory Contact (LRC) and/or Regulatory Lead (RL).
• Support of CTIS submissions, amendments, notifications and regulatory interactions with regulatory authorities.
• Management of post-authorisation activities, including variations, renewals, transfers and other lifecycle maintenance procedures.
• Review and update of product information documents (SmPC, PIL, labelling texts) and artwork materials in compliance with local and EU requirements.
• Coordination with internal project teams, clients and regulatory authorities to ensure timely and compliant submissions.
• Tracking regulatory commitments, maintaining documentation and supporting regulatory strategy implementation.

Knowledge and experience required for the role:

• Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline
• A few years of experience in a CRO/Pharma
• Previous regulatory affairs experience in CTA and MAA activities within the EU
• Client-focused approach to work
• Excellent interpersonal and intercultural communication skills, both written and verbal
• Critical thinking and problem-solving skills
• Proficiency in English and local language (written and spoken)

Parexel is offering a comprehensive benefits package to ensure your success and growth in this role. We provide training and knowledge of our organization's basic consulting models, methodologies, as well as an understanding of the services we offer. Moreover, you will receive support from our senior staff to accomplish more complex tasks successfully.