Department: Quality Assurance JOB PURPOSE: - To ensure the filing of required regulatory documents on time as per regulatory norms. - Take active participation from initiation of the projects and provide Regulatory strategy inputs to the team and the clients. - Liaise with Regulatory agencies, partners, customers, agents as appropriate. - Take lead for execution of regulatory submission documents for project and be the lead of any Regulatory discussion with the agencies or clients. - Review dossiers, regulatory documents, response to deficiencies as per the business needs. Key Responsibilities: - Head Regulatory Affairs shall be responsible for supporting all regulatory activities associated with product development, new registrations and lifecycle management as per requests from clients for: - Development and scale up as well as production of small molecules, advanced intermediates and NCEs for molecules in early and late phase, as well as for commercial supplies. - Pre-formulation studies, toxicology formulation, formulation development, analytical development and manufacturing of clinical batches under cGMP environment. - Biologics/ Large Molecule Development and commercialization for microbial and mammalian productions including manufacturing from cell line and process development through large scale production and supply of animal studies, clinical trial and commercial material. - Review of plant and R&D documentation such as development reports, BMR, BPR, Specifications, method validation, process validation etc. Provide responses to regulatory agencies regarding product information or issues. Train staff in regulatory policies or procedures. Develop and maintain standard operating procedures or local working practices. - Interface with Clients, key business and cross-functional stakeholders to ensure review of proposal for submission, review of infrastructure, process, resources, IT and systems for on time delivery of the project, submission planning, creation of submission documentation, submission requirements, product/facility change management, process support. - Actively participate in CMC IND, ANDA content development as per project schedule. Analyze any changes in the requirements and implement changes in the database - Accountable for the relationship with the US Food and Drug Administration, EMA, PMDA, MHRA, Drug control of India and other relevant regulatory bodies or govt agencies for regulatory submissions or sourcing purpose. To act as primary contact with US FDA and EMA and other regulatory agencies for activities related to product development or compliance.

Bangalore

Senior General Manager - Regulatory Affairs - Pharma 

Senior General Manager - Regulatory Affairs - Pharma  ,Job Description for Senior General Manager - Regulatory Affairs - Pharma  in Tutelage Professionals Pvt Ltd in  Bangalore for (10-25) years of experience. Apply Now!

Job Description for Senior General Manager - Regulatory Affairs - Pharma  in Tutelage Professionals Pvt Ltd in  Bangalore for (10-25) years of experience. Apply Now!