Regulatory Affairs Consultant (BiologicsSmall Molecules)

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.

• Around 7-10 years of relevant experience in handling life cycle management (LCM) of approved / marketed drug products (small molecules as well as biologicals including Vaccines monoclonal antibodies) in various markets mainly US and EU.
• 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 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 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 Renewals in EU (Type IA / IB / II / IAIN) and US and RoW markets.
• Evaluation of change controls and deviations and identification of required documentation and strategy for EU / US 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
• Review and submit safety variations to Health Authorities and perform post Approval CMC / labeling related updates.
• Authoring content of the drug product label (EU Canada AU / NZ & US) based on Company Core Data Sheet (CCDS) / PRAC / CMDH recommendations.
• Familiarity with EU Guidelines for QRD / Excipients.
• Artwork management for countries with label in English.

Required Experience :

Contract

Key Skills

Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills

Employment Type : Full Time

Experience : years

Vacancy : 1