WFH Regulatory Affairs Consultant at Parexel – Apply Online

WFH Regulatory Affairs Consultant Job at Parexel, Apply Now!

Are you a Regulatory Affairs Professional with expertise in biologics? Parexel Consulting is hiring a Regulatory Affairs Consultant, Biologics to help biopharmaceutical and medical device companies navigate complex regulatory landscapes. In this role, you’ll develop and implement regulatory strategies to accelerate product approvals while ensuring compliance with global standards. With 7–9 years of experience in regulatory submissions and knowledge of international regulatory guidelines, this position offers an exciting opportunity to work with diverse clients across multiple therapeutic areas.

Job Posting: Regulatory Affairs Consultant, Biologics at Parexel

As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.

Key Responsibilities for Regulatory Affairs Consultant Job:

• Author, compile, and submit regulatory submission files (MAA and post-approval changes) for biologic products in regulated (EU, US, Canada) and emerging markets.

• Prepare and deliver regulatory maintenance submissions, progressing from simple to more complex submissions as experience grows.

• Ensure compliance with regulatory guidelines, frameworks, and trends applicable to biologics and various submission types required for Regulatory Affairs Job.

• Collaborate with clients to develop and maintain submission delivery plans and proactively provide status updates.

• Utilize Regulatory Information Management Systems (RIMS) such as Veeva Vault to manage regulatory processes efficiently.

• Work independently while maintaining strong communication and collaboration with internal teams and clients.

Required Qualifications for Regulatory Affairs Consultant Job:

• Bachelor’s or Master’s degree in life sciences, pharmacy, biotechnology, or a related field.

• 7–9 years of experience in regulatory affairs for biologics, including authoring, compiling, and submitting regulatory files.

• Strong knowledge of regulatory guidelines and frameworks in regulated and emerging markets.

• Experience with Regulatory Information Management Systems (RIMS), preferably Veeva Vault.

• Excellent problem-solving, organizational, and communication skills.

• Ability to work independently and manage multiple projects effectively.

Preferred Qualifications for Regulatory Affairs Consultant Job:

• Experience in post-approval regulatory changes and lifecycle management for biologics.

• Knowledge of global regulatory trends and procedures.

• Strong relationship-building skills and ability to collaborate with cross-functional teams.

Why Join Parexel?

• Collaborative Environment: Work with a dynamic and supportive team of regulatory professionals.

• Diverse Client Base: Gain exposure to a variety of product types and therapeutic areas.

• Career Growth: Enhance your expertise through challenging assignments and mentorship.

• Flexibility: Enjoy the flexibility of remote work while staying connected with a global team.

APPLY ONLINE HERE

Keywords: Regulatory Affairs Consultant, Biologics, Parexel, Regulatory landscape, Biopharmaceutical, Medical device, Regulatory strategies, Scientific, Technical, Global perspective, Regulatory guidelines