Key Facts

Remote From:

Full time

Mid-level (2-5 years)

English

Hard Skills

Common Technical Document Regulatory Compliance Regulatory Compliance FDA Regulations Regulatory Compliance Cross-Functional Collaboration Stakeholder Communications

Roles & Responsibilities

Regulatory Affairs-CMC experience, 2 to 4 years
Willing to work in EU shifts
Knowledge of CTD guidelines
Experience in lifecycle management in EU markets (preferred)

Requirements:

Understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions
Support annual reports and renewals across US/EU/Brazil/LATAM/China
Liaise closely with cross-functional members with aligned product responsibilities
Assist with lifecycle management activities in EU markets (preferred)

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 Associate

2 to 4 years of experience in Regulatory Affairs-CMC, should be willing to work in EU Shifts.

• To understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.

• Support Annual reports/Renewal experience US/ EU/Brazil/LATAM/China.

• Liaise closely with cross-functional members with aligned product responsibilities.

• Knowledge of change evaluation according to country guidelines

• Experience in managing lifecycle activities in the EU markets would be preferrable

• Knowledge of CTD guidelines

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