Regulatory Team Lead - Non CMC
Regulatory Team Lead - Non CMC
Posted on :
10-12-2024
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1 Vacancy
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Job Description
Job purpose
To Manage Regulatory Affairs for in compliance to applicable regulations and guidelines. This position will assist with the review of clinical/Biopharmaceutical/Non Clinical and labelling documentation preparation and review of nonCMC sections Variations site transfers and post approval gap analysis. This position will also provide support of the regulatory function through document management electronic submission compilation and management and other group management activities as required. Position will be required to work with Regulatory Affairs Quality Assurance Quality Control Manufacturing Research and Development groups of the client organization
Duties and responsibilities
Providing highquality Clinical Biopharmaceutical Pharmacokinetic nonclinical review of CTD sections for regulatory filings to SRA (e.g EMA UK MHRA National Agencies of EU Member states Canada Australia) as well as agencies of ROW markets
Actively contribute to the development and implementation of regulatory strategies processes and timelines for global approval.
Carrying out Gap Analysis of NonCMC sections for small molecules and biopharmaceuticals
Authoring and compiling CTDs sections Variations (Major/Minor/Site Transfers) filings ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met.
Prepare &/or review labelling documentation Managing labelling changes prepare variation application on labelling changes intended for submission to the above mentioned agencies internal consistency for consistency to relevant guidelines and to promote regulatory excellence.
Demonstrate subject matter and area expertise. Collaborate with internal and external clients.
Supporting and enabling effective and efficient communication that results in operational excellence.
Providing technical consultation and provides substantive advice on strategy regulations and industry best practices.
Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on agencies website.
Monitor competitive regulatory practices and actively review internal and external factors to mitigate potential problems.
Ensure that draft labeling complies with all applicable regulations and guidelines
Education & Experience
Bachelors or Masters 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
Excellent oral and written communication skills with strong presentation skills
Significant knowledge of global regional national and other document development guidelines
Indepth knowledge in a specialty area such as preclinical therapeutic regulatory submissions communications etc.
Great judgment and decisionmaking 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 teamoriented 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 resultsdriven 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 13
Location Gurgaon Haryana (INDIA)
Interested candidates can share resumes at
Employment Type
Full Time
Key Skills
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