At Parexel, we are driven by a shared mission—to enhance global health. From clinical trials to regulatory consulting and market access, our clinical development solutions are fueled by a deep commitment to making a difference. Every role at Parexel contributes to therapies that ultimately benefit patients. We approach our work with empathy, dedication, and a passion for innovation.
Job Description: Regulatory Affairs Consultant – Small Molecules
Key Responsibilities:
- Handle pre-approval (IND, NDA) and post-approval lifecycle management of drug products across global markets.
- Prepare and review regulatory submissions (including authoring) for global and regional maintenance filings.
- Manage CMC-related health authority queries and ensure compliance with regulatory standards.
- Demonstrate working knowledge of EU and US regulatory procedures, including post-approval requirements. Familiarity with ROW (Rest of World) markets is a plus.
- Prepare and review Marketing Authorization Applications (MAAs) & Variations for oral and parenteral products in the EU via DCP, MRP, and National Procedures.
- Handle variation procedures (Super Grouping, Grouping, Work-sharing) for Marketing Authorizations.
- Conduct regulatory reviews of DMFs, batch records, specifications, and stability data for compliance.
- Provide regulatory impact assessments for change proposals and identify required documentation for EU submissions.
- Collaborate with cross-functional teams to ensure timely and compliant submissions.
- Maintain submission delivery plans and provide status updates to stakeholders.
- Prepare, review, and submit safety variations to Health Authorities.
- Work with Regulatory Information Management Systems (RIMS), particularly Veeva Vault.
- Mentor and guide team members while ensuring first-time quality and efficiency in projects.
Qualifications & Experience:
- 8-10 years of regulatory affairs experience in small molecules.
- Strong understanding of global regulatory frameworks (ICH, US FDA, EMA, ROW).
- Experience in CMC regulatory affairs for both small and large molecules.
- Excellent communication and leadership skills.
- Ability to work independently under tight deadlines.
About Parexel
Parexel is a leading Clinical Research Organization (CRO) dedicated to advancing drug development and regulatory compliance. With a focus on patient-centric solutions, Parexel supports biopharmaceutical companies in navigating complex regulatory landscapes.
Why Join Parexel?
✅ Impactful Work – Contribute to life-changing therapies.
✅ Global Exposure – Work with international regulatory standards.
✅ Innovative Environment – Leverage advanced tools like Veeva Vault.
✅ Career Growth – Opportunities for mentorship and leadership.
