Job Posting: Senior Regulatory Affairs Associate – Biologics
Job Description
As a Senior Regulatory Affairs Associate at Parexel Consulting, you will be instrumental in aiding biopharmaceutical and medical device companies to navigate the intricate and evolving regulatory landscape. Utilizing your scientific, technical, and regulatory expertise, you will collaborate closely with clients to formulate and execute regulatory strategies that expedite the market entry of their products and ensure sustained compliance.
We place a high value on collaboration, innovation, and continuous learning. As part of our team, you will engage with a diverse array of clients and be exposed to various product types and therapeutic areas. You will enhance your skills through challenging assignments and mentorship from seasoned regulatory professionals. Additionally, you will benefit from the flexibility of remote work while being part of a supportive and dynamic team.
Candidate Profile
- Experience: 4-8 years of relevant experience in the pre and post-approval lifecycle management of biologic drug products across various markets.
- Regulatory Knowledge: Strong understanding of regulatory frameworks, including regional trends for various applications and procedures.
- Submission Preparation: Contribute to the preparation and delivery of regulatory maintenance submissions, initially simple and increasingly complex with experience, from a global and/or regional perspective.
- Procedural Expertise: Working knowledge of EU/US regulatory procedures, including post-approval requirements. Familiarity with ROW market regulations is advantageous.
- CMC Handling: Experience in addressing CMC-related health authority queries.
- Comprehensive Framework Understanding: Deep understanding of regulatory frameworks for both small and large molecules across all regions, along with knowledge of global pharmaceutical legislation and guidance on regulatory CMC aspects in ICH countries.
- Documentation Preparation: Prepare and review Marketing Authorization Applications & Variations for various medicinal products (Orals & Parenterals) for EU filings through different procedures (DCP/MRP/National Procedures).
- Variation Procedures: Prepare documentation for Variation procedures like Super grouping, Grouping, and Work-sharing for Marketing Authorizations.
- Regulatory Compliance: Review DMFs, batch records, specifications, and stability data to ensure compliance with regulatory requirements.
- Impact Assessment: Provide regulatory impact assessments for change proposals and identify necessary documentation for EU submissions.
- Cross-Functional Collaboration: Work closely with cross-functional team members with aligned product responsibilities.
- Submission Management: Execute and maintain submission delivery plans, and submission content plans, and proactively provide status updates to stakeholders.
- Safety Variations and Updates: Prepare, review, and submit safety variations to Health Authorities and manage post-approval CMC-related updates.
- Regulatory Information Systems: Experience with Regulatory Information Management Systems such as Veeva Vault.
- Communication Skills: Strong communication skills and the ability to guide and mentor team members.
Additional Information
- Experience: 4-8 years
- Location: Hyderabad, Telangana; Mumbai, Maharashtra
- Industry Type: Pharma/Healthcare/Clinical Research
- Functional Area: Regulatory Affairs
- End Date: 30th June 2024
If you meet the qualifications and are passionate about making a difference in the biopharmaceutical industry, we encourage you to apply for this exciting opportunity at Parexel Consulting.
