Team Lead – Regulatory Affairs – Non_CMC
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 non-CMC 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 of DDReg.
Duties and responsibilities
- Providing high-quality Clinical, Biopharmaceutical, Pharmacokinetic, non-clinical 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 for DDReg clients
- Actively contribute to the development and implementation of regulatory strategies, processes and timelines for global approval.
- Carrying out Gap Analysis of Non-CMC 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
- 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
- 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
Location
Gurgaon, Haryana (INDIA)