Parexel Hiring Remote Senior Regulatory Affairs Associate

opportunity to work remotely as a Senior Regulatory Affairs Associate at Parexel. Learn about the qualifications, responsibilities, and locations available in India, including Remote, Hyderabad, and Mumbai.

About Parexel: Parexel is a renowned consulting firm specializing in helping biopharmaceutical and medical device companies navigate regulatory challenges. Join a dynamic team focused on innovation and collaboration, with opportunities for continuous learning and career growth.

Role Overview: Senior Regulatory Affairs Associate

Qualifications:

• Around 4-8 years of relevant experience in drug product life cycle management
• Good understanding of global regulatory frameworks, including EU/US procedures
• Experience in handling CMC-related queries and submissions
• Working knowledge of Regulatory Information Management Systems like Veeva Vault
• Strong communication and mentoring skills
• Ability to work independently and collaborate effectively with cross-functional teams

Responsibilities:

• Around 4-8 years of relevant experience in handling of pre and post approval life cycle management of  drug products (small molecules as well as biologics) in various markets.
• Good understanding of regulatory framework, including regional trends, for various types of applications and procedures
• 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.
• Working knowledge of EU/US regulatory procedures including post approval requirements. Knowledge of ROW markets regulatory legislations would be an added advantage
• Experience in handling CMC related health authority queries
• Good understanding of regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions as well as knowledge of global pharmaceutical legislation and guidance specifically linked to regulatory CMC aspects in the ICH countries.
• Preparation and review of Marketing Authorization Applications & Variations for various types of medicinal products (Orals & Parenterals) for filing in EU through different types of procedures (DCP/MRP/National Procedures).
• Preparation of documentation for different types of Variation procedures like Super grouping,
• Grouping and Work-sharing to the Marketing Authorizations.
• Regulatory review of DMFs, batch records, specifications, and stability data to ensure their compliance with the regulatory requirements.
• Providing regulatory impact assessment for change proposals and identification of required documentation for EU submissions
• Liaise closely with cross-functional members with aligned product responsibilities.
• Execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
• To prepare, review and submit safety variations to Health Authorities and perform post Approval CMC related updates.
• Working experience in Regulatory Information Management Systems like Veeva Vault.
• Strong communications skills and ability to guide and mentor team members

Success Profile: Are you a communicator, detail-oriented problem solver with a strategic mindset? Parexel values individuals who can build relationships, drive results, and contribute to strategic regulatory initiatives.

How to Apply: Interested candidates can apply for the Remote Senior Regulatory Affairs Associate position at Parexel through the official job listing here.