Regulatory Affairs Consultant- CMC Biologics

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's 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 we're 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 Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred