Key Facts

Remote From:

Freelance

Senior (5-10 years)

English

Hard Skills

Product Lifecycle Management Vaccine Development Regulatory Compliance Regulatory Compliance Regulatory Compliance Regulatory Compliance Medicines And Healthcare Products Regulatory Agency (MHRA) Guides International Laws

Other Skills

•
Teamwork
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Communication

Roles & Responsibilities

8-10 years' regulatory affairs experience in handling new registrations, lifecycle management, and renewals for biologicals, vaccines, recombinant proteins, monoclonal antibodies, plasma-derived products, and small molecules
Experience across multiple markets including US, EU, Japan, Canada, Switzerland and Australia
Strong understanding of regulatory frameworks, regional trends, and CMC requirements per ICH regions
Excellent communication, collaboration, and ability to work independently

Requirements:

Contribute to preparation and delivery of regulatory submissions from global and regional perspectives, including authoring where relevant
Prepare and review Marketing Authorization Applications and Variations for filing in US, EU, Japan, Canada, Switzerland, and Australia
Maintain and apply a strong understanding of regulatory frameworks and regional trends for small and large molecules, with knowledge of CMC requirements in ICH regions
Demonstrate strong communication, collaboration, and the ability to work independently across cross-functional teams

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.

Regulatory Affairs Consultant

8 to 10 years' experience in handling of new registration, life cycle management, renewals of Biologicals, Vaccines, recombinant protein molecules, monoclonal antibodies, plasma derived and small molecules in various markets, mainly in US, EU, Japan, Canada Switzerland, Australia.
Contribute to preparation (including authoring where relevant) and delivery of regulatory submissions from a global and regional perspective.
Preparation and review of Marketing Authorization Applications & Variations for filing in US, EU, Japan, Canada Switzerland, Australia.
Good understanding of regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions as well as knowledge of global pharmaceutical legislation and guidance specifically linked to regulatory CMC aspects in the ICH countries.
Strong communication and collaboration skills, ability to work independently.