Senior Manager/ Team Lead - Regulatory Affairs
- ApicalGo Consultancy
- 3 - 5 yrs
- Noida, Gurugram
- 5 years ago
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Desired Candidate Profile
Senior Manager/Team Lead - Regulatory Affairs - Emerging Markets - Pharma (5-7 yrs)
To Manage Regulatory Review and Compilation for Various Markets in compliance to applicable regulations and guidelines. Duties and responsibilities : - Providing high-quality CMC review of technical documentation for regulatory filings in emerging markets, for clients - Drive the compilation team with 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 Education & Experience : - Bachelor's or Master's degree in Pharma - Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years- ) or equivalent combination of education, training, & experience. - Experience working in the pharmaceutical/CRO industry preferred Knowledge, Skills and 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 - 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 Other requirements : As may be required from time to time - the incumbent may be required to working slots catering to different time zones Direct reports : 0 to start with, Reports to Director
Education:
UG: Any Graduate - Any Specialization, B.Sc - Any Specialization, B.Pharma - Pharmacy
PG: Any Postgraduate - Any Specialization, MS/M.Sc(Science) - Any Specialization, M.Pharma - Pharmacy
Doctorate: Doctorate Not Required
Contact Details:
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Keyskills: Regulatory Affairs CTD Operational Excellence Senior Management Technical Documentation Document Management Project Management Management Systems Team Leading Problem Solving
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