[Work From Home] Parexel Hiring for Regulatory Affairs Associate (Biologics)

[Work From Home] Parexel Hiring for Regulatory Affairs Associate (Biologics)

Job Overview

Job Title	Regulatory Affairs Associate (Biologics)
Company	Parexel
Experience	4-6 years
Location	Work From Home
Date Posted	October 2, 2024
Job Type	Full-time
Key Skills	Regulatory Compliance, Biologics, MAA, Life Cycle Management, Veeva Vault
Contact	Not disclosed

Exciting Opportunity as a Regulatory Affairs Associate at Parexel

Are you an experienced Regulatory Affairs professional looking to make a significant impact in the biopharmaceutical world? Look no further! Parexel, a global leader in regulatory solutions for the healthcare industry, is hiring a Regulatory Affairs Associate (Biologics) for a work-from-home opportunity. In this dynamic role, you’ll be at the forefront of ensuring life-saving biologic products get approved and remain compliant across various markets, including the US, EU, and Canada. [Work From Home] Parexel Hiring for Regulatory Affairs Associate (Biologics)

Why Join Parexel?

At Parexel, we specialize in providing regulatory expertise to support the lifecycle management of biopharmaceutical and medical device products. As a key member of our team, you’ll have the unique opportunity to work on the latest biologic products, helping to bring innovative treatments to patients worldwide. Working with a company that has a global presence, you’ll not only grow professionally but also gain exposure to cutting-edge technologies and regulatory practices that shape the future of healthcare.

Your Role in Regulatory Affairs

As a Regulatory Affairs Associate, your primary responsibility will be to support the regulatory life cycle management of biologics across various global markets. You’ll be working with teams across different countries, ensuring that new products are approved and stay compliant with ever-changing regulations.

Some of your main responsibilities will include: [Work From Home] Parexel Hiring for Regulatory Affairs Associate (Biologics)

• Managing Regulatory Life Cycle for Biologics: Oversee the regulatory process for biologic products, including both pre- and post-approval phases in regulated and emerging markets.
• Supporting Regulatory Submissions: Play a key role in the compilation, submission, and approval of Marketing Authorization Applications (MAA), ensuring they meet the specific guidelines of each region.
• Handling Post-Approval Variations: After a product is approved, you’ll be responsible for handling life cycle management (LCM) to ensure continued compliance and approval of any changes or variations.
• Ensuring Global Regulatory Compliance: Stay on top of local and international regulations by regularly updating submission plans and communicating compliance requirements to the necessary stakeholders.
• Collaborating with Cross-Functional Teams: Work closely with cross-functional teams to ensure all product responsibilities are aligned, from regulatory affairs to manufacturing and quality assurance. [Work From Home] Parexel Hiring for Regulatory Affairs Associate (Biologics)

What Makes You a Great Fit?

This position is ideal for someone with 4-6 years of regulatory experience, specifically with biologic products. You’ll need a solid understanding of both local and international regulatory frameworks and the ability to adapt quickly to changes in guidelines.

• Regulatory Expertise: Hands-on experience with regulatory submissions in regulated markets like the EU, US, and Canada is essential. Familiarity with Marketing Authorization Applications and Life Cycle Management is a must.
• Collaborative Spirit: In this role, collaboration is key! You’ll work with various teams, both internally and externally, to ensure the smooth execution of regulatory plans.
• Attention to Detail: As a Regulatory Affairs Associate, attention to detail is critical. You’ll be managing important documents and making sure all submissions meet the necessary requirements.
• Familiarity with Regulatory Systems: Experience working with Regulatory Information Management Systems like Veeva Vault will be highly beneficial in this role.

Benefits of Working at Parexel

By joining Parexel, you become part of a global network of professionals who are passionate about advancing healthcare through regulatory expertise. Work-from-home flexibility allows you to manage your work-life balance effectively while making meaningful contributions to the industry.

Parexel offers opportunities for professional growth, career advancement, and exposure to global markets, making this role an exciting chance to enhance your regulatory expertise. [Work From Home] Parexel Hiring for Regulatory Affairs Associate (Biologics)

How to Apply

If you have the experience and passion for regulatory affairs, particularly in biologics, this is the opportunity for you! You will have the chance to work with innovative products, collaborate with talented teams, and be a key player in bringing life-saving treatments to patients worldwide.

Interested candidates should send their applications or inquiries to the HR department via Parexel’s website or contact information provided in the official job posting.

Application Link

Don’t miss this chance to join one of the leading companies in regulatory solutions and shape the future of healthcare!

More Jobs