Senior Regulatory Affairs Consultant at Parexel

, , Brazil -

Full Time

Start Date

Immediate

Expiry Date

27 Mar, 26

Salary

0.0

Posted On

27 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Consulting Skills, Critical Thinking, Problem Solving, Project Leadership, Management Knowledge, Interpersonal Skills, Communication Skills, Client Focus, Results Orientation, Teamwork, Collaboration Skills, Networking, Business Analysis, Self-Confidence

Industry

Pharmaceutical Manufacturing

Description

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. The Senior Consultant is responsible for overseeing end-to-end labeling development and implementation across Foundational markets (US, EU, CH, DE, AU) and non-US/Central EU regions. This role ensures compliance with country-specific regulatory requirements and manages operational processes for artwork creation, translation, and implementation. Acting as a key partner to Global Regulatory Affairs (GRA) Regions, Regulatory CMC, and Supply Chain, the Senior Consultant provides strategic guidance and operational leadership to support global labeling initiatives. Key Accountabilities: Oversees end-to-end labeling development and implementation for Foundational (US, EU, CH, DE, AU) and non-US/Central EU markets. Key Responsibilities: Ensure compliance with country-specific regulatory requirements. Manage operational processes for artwork creation, translation, and implementation. Act as key partner to GRA Regions, Regulatory CMC, and supply chain. Skills: 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. Networking. Business analysis. Self-confidence and control. Education: Minimum of a bachelor’s degree in a Scientific or Technical Discipline, Advanced Degree preferred. Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™

Responsibilities

The Senior Consultant oversees end-to-end labeling development and implementation for various markets, ensuring compliance with regulatory requirements. They act as a key partner to Global Regulatory Affairs and provide strategic guidance for global labeling initiatives.