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.
- Relevant experience in handling the life-cycle management of approved drug products, including small molecules and biologics (vaccines and monoclonal antibodies), across various global markets.
- Good understanding of the regulatory framework, including regional trends, for different types of applications and procedures.
- Contribute to the preparation (including authoring, where relevant) and delivery of simple regulatory maintenance submissions and, with experience, increasingly complex submissions from a global and/or regional perspective.
- Working knowledge of EU and US regulatory procedures, including post-approval requirements. Knowledge of regulatory legislation in Rest of World (ROW) markets would be an added advantage.
- Experience in handling CMC-related Health Authority (HA) queries and authoring responses to HA requests.
- Strong understanding of regulatory frameworks, including regional trends, for various application types and procedures related to both small and large molecules across global markets, as well as knowledge of global pharmaceutical legislation and guidance, particularly regulatory CMC aspects within ICH countries.
- Experience in authoring and reviewing the CMC components of Marketing Authorization Applications (MAAs) and Variations for different types of medicinal products (oral and parenteral) filed in the EU through DCP, MRP, and National Procedures.
- Preparation of documentation for various variation procedures, including Super Grouping, Grouping, and Work-Sharing applications for Marketing Authorizations.
- Regulatory review of DMFs, batch records, specifications, and stability data to ensure compliance with applicable regulatory requirements.
- Author CMC components of Annual Reports, renewals (Modules 1, 2, and 3), and GMP-related submissions, including site registrations.
- Provide regulatory impact assessments for change controls and identify the documentation required for EU, US, and other market submissions.
- Liaise closely with cross-functional teams and stakeholders to ensure alignment on product-related responsibilities.
- Execute and maintain submission delivery plans and submission content plans, while proactively providing status updates to designated stakeholders.
- Prepare, review, and submit safety variations to Health Authorities and perform post-approval CMC-related updates.
- Working experience with Regulatory Information Management Systems (RIMS), such as Veeva Vault.
- Experience in authoring and maintaining labeling content for the EU, US, Canada, and Australia/New Zealand markets based on the Company Core Data Sheet (CCDS), PRAC recommendations, and CMDh recommendations.
- Familiarity with EU QRD template requirements and European Commission guidelines on excipients in medicinal products.
- Bachelor's degree in Pharmacy, Life Sciences, Chemistry, Biotechnology, or a related scientific discipline.
- Master's degree preferred.
Skills Required
- Around 4-6 years of relevant experience in handling life cycle management of approved drug products
- Good understanding of regulatory framework for various types of applications and procedures
- Working knowledge of EU/US regulatory procedures including post approval requirements
- Experience in handling CMC related health authority queries
- Good understanding of global pharmaceutical legislation and regulatory CMC aspects
- Experience with Regulatory Information Management Systems like Veeva Vault
- Strong communication skills and ability to mentor team members
Parexel Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Parexel and has not been reviewed or approved by Parexel.
-
Healthcare Strength — Health coverage is described as comprehensive, including medical, dental, vision, HSA/FSA options, and company-paid disability insurance. Descriptions often portray the package as strong or “top notch,” adding meaningful value.
-
Retirement Support — Retirement offerings include a 401(k) with company matching and, in some regions, generous pension contributions. Core financial protections are emphasized as a solid part of the total rewards.
-
Leave & Time Off Breadth — Time-off programs include ample PTO or flexible/unlimited RTO alongside flexible schedules and remote/hybrid options. Work-life balance support from managers is highlighted as a practical advantage.
Parexel Insights
What We Do
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.
