To Manage Regulatory Review and Compilation for Various Markets in compliance with applicable regulations and guidelines.
Duties & Responsibilities:
- Providing high-quality CMC review of technical documentation for regulatory filings in EU and US markets, for DDReg clients
- Drive the compilation team with the high quality dossier for various regulated markets
- Providing technical consultation and provides substantive advice on strategy, regulations, and industry best practices.
- Demonstrate subject matter and area expertise.
- Effectively manage CMC projects to deliver quality projects in agreed timelines.
- Collaborate with internal and external clients,
- Supporting and enabling effective and efficient communication that results in operational excellence.
- Managing CTD Modules, Medical Data Packages, SmPCs, PIs, PILs, Labelling reviews
- Demonstrate high-level knowledge of country regulations and regulatory guidelines as updated from time to time on regulatory agency websites like US FDA, EMA, PMDA, TGA, UKMHRA, etc.
Knowledge Skills & Abilities:
- Excellent technical data interpretation skills
- Strong project management skills
- Excellent interpersonal skills including problem-solving
- Strong negotiation skills
- Excellent oral and written communication skills with strong presentation skills,/li>
- Significant knowledge of global, regional, national and other document development guidelines
- In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc.
- Great judgment and decision-making skills Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
- Ability and desire to work in a team-oriented environment.
- Excellent written and verbal communication skills
- Highly proficient with Microsoft Word, PowerPoint and Excel.
- Demonstrates ability to evaluate information and data with a defined, studied process and report results in a thoughtful, organized manner
- Possesses a collaborative, results-driven style.
- Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines
Experience: 5 Years of Relevant Experience, CRO/Pharma Experience Preferred
Mail CV to firstname.lastname@example.org