Key Facts

Remote From:

Full time

Senior (5-10 years)

English

Hard Skills

Regulatory Compliance Regulatory Compliance Lifecycle Management Health Information Management Proposal Software Veeva Control Systems Archival Management Pharmaceutical Sciences Tracking Systems (Geolocation) Regulatory Compliance International Laws Cross-Functional Collaboration Project Management Stakeholder Communications

Other Skills

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Packaging And Labeling
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Microsoft Office
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Communication
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Organizational Skills
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Detail Oriented

Parexel

Pharmaceuticals

About Parexel

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.

Company type: XLarge

Industry: Pharmaceuticals

Founded: 2018

Company size: 10001

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Job 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.

We are seeking a highly organized and detail-oriented Senior Regulatory Affairs Associate to serve as a Regional Submission Coordinator. This is a key operational role responsible for coordinating all activities required to deliver regulatory submissions across assigned regions, ensuring timely and compliant filings that support our clients' drug development programs.

In this role, you will be at the heart of regulatory submission activities, working collaboratively with global teams, local regulatory representatives, and subject matter experts to ensure successful regulatory outcomes.

Key Responsibilities:

Regional Coordination & Stakeholder Management

Coordinate the preparation, compilation, and submission of new drug applications and lifecycle management (LCM) activities in alignment with submission strategy as defined by the Regional Regulatory Lead (RRL) and submission team
Coordinate closely with Global Submission Coordinators to ensure completeness of core documentation required to support regional submission planning and requirements
Organize submission team meetings and facilitate effective communication among all stakeholders including CMC, labelling, RRL, Local Regulatory Representative (LRR), and Regulatory Partner Representative (RPR)
Open required records in submission planning tools and Regulatory Information Management Systems
Prepare Submission Content Plans (SCP) based on country-specific regulatory requirements and prior Health Authority observations to ensure continuous improvement
Coordinate, request, and track documentation from relevant SMEs to ensure timely and complete submission readiness
Provide regular updates to the submission team on status and timelines

M1 Document & Labeling Support

Draft M1 documents as required and coordinate their review with LRR or RPR
Support labeling preparation, notably in Artwork management system and change control system
Upload M1 documents in archiving system and complete the SCP accordingly
Ensure dispatch of non-eCTD regulatory packages to LRR and RPR
Track dispatched documentation for each country
Ensure submitted documentation is uploaded to archiving system for non-eCTD submissions
Update Veeva as required, including uploading each question received by Health Authorities in a record HAI

Skills & Experience required for the role:

University degree in Life Sciences discipline
3-5 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry
Regulatory submission strategy and execution experience, ideally global
Strong understanding of regional regulatory submission processes
Experience with different international regulatory submission routes preferred (e.g., ACCESS, reliance pathways)
Excellent project management and organizational skills
Strong communication and stakeholder management abilities
Proficiency in regulatory tracking systems and Microsoft Office Suite
Fluent in English, written and spoken