Regulatory Affairs Consultant- CMC Biologics
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Job Location:
Monthly Salary:
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
When our values align theres no limit to what we can achieve.
At Parexel we all share the same goal - to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us no matter what we do at Parexel contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally we do it with empathy and were committed to making a difference.
Regulatory Affairs Consultant
Around 7-10 years of relevant experience in handling life cycle management (LCM) of approved/marketed drug products (Biologicals Vaccines ) in various markets mainly in US EU Japan Canada Switzerland Australia.
Good understanding of regulatory framework including regional trends for various types of applications and procedures.
Lead and / or contribute to the planning preparation authoring and delivery of regulatory maintenance submissions from either a global and/or regional perspective.
Working knowledge of US EU Japan Canada Switzerland Australia 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 and author responses to HA requests
Preparation / Review of Regulatory gap analysis and strategy documents (with remediation plans for identified gaps) for submissions like IND IMPD DMF BLA NDA and MAA applications.
Authoring and review of CMC component of Marketing Authorization Applications & Variations for various types of medicinal products (orals & parenteral) for filing in EU through different types of procedures (DCP/MRP/National Procedures).
Authoring CMC component for marketed products of Annual Reports Variations expansions site transfers Renewals in EU (Type IA/IB/II/IAIN) and US Canada Switzerland and RoW markets.
Evaluation of change controls and deviations and identification of required documentation and strategy for US EU Japan Canada Switzerland Australia submissions and other markets.
Co-ordination with internal and external stakeholders for documentation required for various submissions. Identify quality and/or timeliness issues with source documents as early as possible.
Develop up-to-date knowledge about regulatory guideline updates and applying regulatory requirements and their impact on submissions.
Working experience in Regulatory Information Management Systems (RIMS) like Veeva Vault.
Strong communications skills and ability to guide and mentor team members.
Ability to work independently.
Knowledge and Experience:
Several years of experience in an industry-related environment
Education:
Minimum of a Bachelors Degree in a Scientific or Technical Discipline Advanced Degree Preferred
Required Experience:
Contract
Key Skills
About Company
Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our the ... View more
