3 Regulatory Review Jobs

Regulatory Consultant (EU OTC) Responsibilities: Submission support: Submission management support for MRP & DCP procedures, PSUSA submission, Renewals, Repeat use procedures, variations etc. Preparation and compilation of regulatory documentation for the registration, variation and renewal of OTC drugs for EMEA. Prepare cover letter, application form and relevant Module 1 documents for variations. Manage regulatory action item (task) tables including mapping, coordination of regulatory inputs, and timing. Work with regulatory team to develop project implementation plans and manage workload planning to ensure on-time completion of projects and tasks. Regulatory review of submission documents for compliance. Work with cross-functional teams or local affiliates for submission documents and verification of packages. Updating relevant submission tracker. PSUR submission support: Review of EURD updates Tracking licenses for DLP and PSUR submission. Review of draft PSUR document for accuracy of the data. Co-ordinate with different stakeholders for safety related information for PSUR Support submission and handling of queries for PSUR Renewal support: Tracking of licenses for registration and approval. Tracking of approval validity of licenses and renewal timelines. Planning for renewal submission. Co-ordination with cross-functional team for Renewal documentation. Co-ordination with Local RA lead for Renewal documentation and submission. Preparation of Renewal package. Submission of Renewal to health authority and post submission activity. Deliverables: Provide weekly updates (at a minimum or based on client requirement) to relevant colleagues or Project Manager on project status. Internal & Confidential [not for external circulation] Ensure that regulatory standards and timelines are met for all projects. Planning and tracking the status of ongoing regulatory projects Use of regulatory database and IT tools where relevant. Project review every quarter on performance feedback and scope of improvement. Experience/Qualifications: Minimum B.S. Chemistry, Biology, or related fields Minimum of 4-5 years of experience working within a Regulatory Affairs Department (e.g., pharmaceutical, cosmetic, food supplements, etc.), with direct accountability for deliverables or a combination of direct Regulatory Affairs experience and specific interactions with a Regulatory Affairs Department by providing source documentation to CMC, Quality, or Regulatory Operations. Show more Show less

The position of Manager is currently open within the Global Regulatory Affairs Specialty Pharma department. The ideal candidate should hold a M. Pharm education and possess 5-10+ years of hands-on experience in regulatory affairs. The preferred job location is Gurgaon, with Baroda and Mumbai as alternative options. As a Regulatory CMC Product Lead, you will be responsible for providing CMC Regulatory leadership within Regulatory and on cross-functional teams for branded products being developed for markets such as the US, EU, and Canada. Your key responsibilities will include ensuring product lifecycle management through timely submission of annual reports and supplements, as well as delivering all regulatory milestones for higher complexity products. You will also be accountable for leading the development and review of the CMC Regulatory Strategy Document for projects of increasing complexity. In addition, you will be required to support new technology development within the company and demonstrate an unwavering focus on compliance in all activities. Your technical skills should include expertise in the preparation and review of dossiers, response to queries, and communication with agencies for markets like the US and EU. Furthermore, you should have proven experience in critically reviewing scientific information and possess superior oral and written communication skills in multicultural settings. The ideal candidate for this role will have demonstrated leadership skills, including the ability to generate innovative solutions to complex regulatory problems and effectively work with key stakeholders. You should also exhibit flexibility in responding to changing priorities and possess effective leadership, communication, interpersonal, and negotiating skills. Additionally, you should have good inter-personal skills with the ability to direct multi-departmental functions. This role requires a seasoned professional who is proficient in English, with additional language skills considered a plus. A minimum educational requirement of M-Pharm in pharmaceutical sciences is essential for this position. Lastly, you may be required to manage or mentor junior team members as part of your responsibilities.,

Regulatory Oversight: 1. Ensure compliance with employment laws, regulations, and organizational policies. 2. Monitor changes in labor laws and update policies accordingly. Policy Development: 3. Frame, Develop, implement, and maintain HR policies and procedures that reflect best practices and legal standards. 4. Regularly review and update compliance-related documents. Training and Awareness: 5. Conduct compliance training programs for employees. Compliance Audits: 6. Plan and execute internal audits to assess adherence to compliance policies. 7. Identify areas for improvement and implement corrective actions. Investigations: 8. Lead investigations into compliance-related complaints or violations. 9. Document findings and recommend disciplinary actions as needed. Record Keeping: 10. Maintain accurate and secure employee records in compliance with legal requirements. 11. Ensure proper documentation of all HR processes and decisions. Reporting: 12. Prepare and present compliance reports to senior management. Advisory Role: 13. Provide guidance to management on HR-related legal matters and compliance issues. 14. Act as a resource for employees regarding compliance concerns. Risk Management: 15. Identify potential compliance risks Location: Malad