Regulatory Affairs Associate

As a Regulatory Affairs Associate at our organization with over 10 years of experience in the Pharma raw material industry, specializing in excipient products, you will be responsible for handling technical queries and regulatory documentation for our newly launched E-commerce platform, CLYZO. Key Responsibilities: - Manage the entire regulatory documents of excipients. - Resolve technical queries from prominent pharmaceutical clients. - Handle technical matters and document-related work for the excipient manufacturer. - Prepare in-house technical documents required for the promotion of excipient products. - Provide specific technical documents for manufacturer and product qualification. - Address regulatory qualification documents and queries for Excipients/in-actives. - Coordinate with Excipients/in-actives manufacturers overseas. - Conduct USP/EP/JP Monograph comparison for various excipients/in-actives. - Prepare documents for Pharmaceutical companies concerning Excipients Qualification. - Manage Virtual Audits of Pharma Customers regarding Excipients Qualification. - Oversee the Vendor Qualification Process end-to-end for Excipients Raw Material Products. Qualifications Required: - Good Technical Know-how regarding Guidelines/GMP/Testing Methods for Excipients. - Experience in vendor management. - Minimum of 2 years of experience in a similar role. - Candidates from a Pharma background will be preferred. The organization offers competitive remuneration and benefits within the industry. This is a full-time, permanent position that includes benefits such as cell phone reimbursement, health insurance, and Provident Fund. The role requires working day shifts, with the possibility of field visits to Pharma customers for a minimum of 3.5 days a week. Candidates must be available to join immediately and should be willing to take up a client-facing role involving meetings with Pharma clients in Hyderabad. Preference will be given to candidates from a Pharma/chemical background. If you believe you possess the right qualifications for this role, we encourage you to apply as we would like to connect with you. As a Regulatory Affairs Associate at our organization with over 10 years of experience in the Pharma raw material industry, specializing in excipient products, you will be responsible for handling technical queries and regulatory documentation for our newly launched E-commerce platform, CLYZO. Key Responsibilities: - Manage the entire regulatory documents of excipients. - Resolve technical queries from prominent pharmaceutical clients. - Handle technical matters and document-related work for the excipient manufacturer. - Prepare in-house technical documents required for the promotion of excipient products. - Provide specific technical documents for manufacturer and product qualification. - Address regulatory qualification documents and queries for Excipients/in-actives. - Coordinate with Excipients/in-actives manufacturers overseas. - Conduct USP/EP/JP Monograph comparison for various excipients/in-actives. - Prepare documents for Pharmaceutical companies concerning Excipients Qualification. - Manage Virtual Audits of Pharma Customers regarding Excipients Qualification. - Oversee the Vendor Qualification Process end-to-end for Excipients Raw Material Products. Qualifications Required: - Good Technical Know-how regarding Guidelines/GMP/Testing Methods for Excipients. - Experience in vendor management. - Minimum of 2 years of experience in a similar role. - Candidates from a Pharma background will be preferred. The organization offers competitive remuneration and benefits within the industry. This is a full-time, permanent position that includes benefits such as cell phone reimbursement, health insurance, and Provident Fund. The role requires working day shifts, with the possibility of field visits to Pharma customers for a minimum of 3.5 days a week. Candidates must be available to join immediately and should be willing to take up a client-facing role involving meetings with Pharma clients in Hyderabad. Preference will be given to candidates from a Pharma/chemical background. If you believe you possess the right qualifications for this role, we encourage you to apply as we would like to connect with you.