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Regulatory Affairs Associate

Parexel

Role overview

Qualifications

  • 3+ years experience in post-approval regulatory activities
  • Experience with European procedures (CP, MRP, DCP, National Procedures)
  • Detail-oriented
  • Knowledge of regulatory requirements

Responsibilities

  • Perform Regulatory Impact Assessments (RIA) for Change Controls raised in TrackWise
  • Assess regulatory implications of changes in manufacturing, quality, labeling, and product information
  • Manage and maintain regulatory change records within Veeva RIMS
  • Support implementation of regulatory strategies for post-approval changes

Key facts

Hard skills

Health Impact Assessments TrackWise Change Management Gap Analysis Compliance Management

Other skills

  • Detail Oriented
  • Collaboration
  • Empathy

About the company

Parexel logo

Parexel

Contract Research Organizations (CRO)

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 details

Company typeXLarge
IndustryContract Research Organizations (CRO)
Company size10001

Links

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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 detail-oriented Regulatory Affairs Specialist with 3+ yrs experience in post-approval regulatory activities for medicinal products registered through European procedures (CP, MRP, DCP, and National Procedures). The successful candidate will support lifecycle management activities, regulatory submissions, CMC documentation updates, and health authority interactions while ensuring compliance with applicable regulatory requirements.

Key Responsibilities

  • Perform Regulatory Impact Assessments (RIA) for Change Controls raised in TrackWise.
  • Assess regulatory implications of manufacturing, quality, labeling, and product information changes.
  • Manage and maintain regulatory change records within Veeva RIMS.
  • Support implementation of regulatory strategies for post-approval changes.
  • Review, update, and author Module 3 sections of CTD dossiers for medicinal products.
  • Ensure CMC documentation remains current and compliant with regulatory expectations.
  • Support dossier lifecycle maintenance activities across multiple markets.
  • Conduct comprehensive Gap Analysis of Module 3 documentation.
  • Identify compliance risks, data gaps, and documentation deficiencies.
  • Develop and recommend remediation plans and regulatory strategies to address identified gaps.
  • Manage post-approval regulatory activities throughout the product lifecycle.
  • Support maintenance of marketing authorizations across EU markets.
  • Collaborate with cross-functional teams to ensure timely execution of regulatory commitments.

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Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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