Offer summary

Qualifications:

4 to 8 years of experience in regulatory affairs for biologics., Proficiency in authoring and submitting country-specific regulatory files (MAA, post-approval changes)., Good understanding of regulatory guidelines and frameworks across multiple markets (EU, US, Canada, emerging markets)., Experience with Regulatory Information Management Systems like Veeva Vault..

Key responsibilities:

Prepare and submit regulatory documentation for biologics in various markets.

Maintain and execute submission delivery and content plans, providing regular updates to stakeholders.

Contribute to the development and delivery of regulatory maintenance submissions.

Collaborate effectively with cross-functional teams and work independently.

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.

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.

Senior Regulatory Affairs Associate ( Biologics )

4 to 8 years of experience of authoring, compiling and submission of country-specific submission files (MAA, and post-approval changes) of Biologic products in various markets - Regulated (EU/US/Canada) and Emerging Markets. Contribute to preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and/or regional perspective.
Good understanding of regulatory guidelines, regulatory framework, including regional trends, for various types of applications and procedures. Working experience in Regulatory Information Management Systems like Veeva Vault.
Execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
Strong communications and collaboration skills. Ability to work independently.

Required profile