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.
This role focuses on managing post-approval regulatory activities, including variations, renewals, and compliance with country-specific requirements. You will partner with cross-functional teams to ensure timely submissions and maintain regulatory dossiers.
Key Responsibilities
• 4+ yrs experience in support regulatory submissions including MAAs (Marketing Authorization Application), variations (minor/major), responses to questions, renewals, withdrawals, and marketing authorization transfers.
Working knowledge on EU procedures including centralized procedures coordination and management.
• Preparation and coordination for Module 1 activities for CMC, Safety, Administrative, MA transfer’s, Article 31 & other post approval variations & MAA’s.
• Assist with DHCP (Direct Healthcare Professional Communication) related activities and commitments follow-up
• Manage submissions through local Health Authority portals as required
• Handle post-approval lifecycle management activities and regulatory communication-RIMS
(Regulatory Information Management Systems)-VEEVA Vault
• Support linguistic review processes including translation review and coordination
• Conduct readability testing and support artwork (AW) review, mock-ups, and approvals
• Support promotional material review including Abbreviated Product Information
(API) creation or updates and Regulatory Affairs review processes (including UK pre-vetting)
• Assist in Periodic Safety Update Report (PSUR) submissions and regulatory intelligence activities at the country level.
Skills Required
- 7+ years supporting regulatory submissions (MAAs, variations, renewals, responses, withdrawals, MA transfers)
- Working knowledge of EU procedures including centralized procedures coordination and management
- Preparation and coordination of Module 1 activities for CMC, Safety, Administrative, MA transfers, Article 31 and other post-approval variations and MAAs
- Experience with DHCP (Direct Healthcare Professional Communication) activities and commitments follow-up
- Ability to manage submissions through local Health Authority portals
- Experience with regulatory communication and Regulatory Information Management Systems (RIMS), specifically VEEVA Vault
- Support linguistic review processes, including translation review and coordination
- Conduct readability testing and support artwork review, mock-ups, and approvals
- Support promotional material review including Abbreviated Product Information (API) creation/updates and UK pre-vetting
- Assist with Periodic Safety Update Report (PSUR) submissions and country-level regulatory intelligence activities
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.
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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.
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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.
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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.
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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.
