Regulatory Affairs Consultant (BiologicsSmall Molecules)
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Job Location:
Monthly Salary:
Posted on:
30+ 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.
- 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
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
