3 Regulatory Intelligence Jobs

Job Summary The TM-Pharmacovigilance role involves ensuring the safety and efficacy of pharmaceutical products through vigilant monitoring and analysis. With a focus on regulatory intelligence the candidate will contribute to maintaining compliance and enhancing customer service. This hybrid role requires rotational shifts and proficiency in English with no travel obligations. Responsibilities Monitor and analyze adverse drug reactions to ensure patient safety and product efficacy. Collaborate with cross-functional teams to gather and interpret regulatory intelligence data. Provide expert guidance on pharmacovigilance processes to enhance customer service experiences. Develop and implement strategies for effective risk management and mitigation. Ensure compliance with global regulatory standards and guidelines in pharmacovigilance activities. Oversee the preparation and submission of regulatory reports and documentation. Conduct thorough research to support the development of new pharmacovigilance methodologies. Facilitate communication between stakeholders to ensure seamless regulatory affairs processes. Utilize advanced analytical tools to assess and improve pharmacovigilance systems. Lead initiatives to optimize research and development efforts in drug safety. Support the integration of regulatory intelligence into strategic planning and decision-making. Drive continuous improvement in pharmacovigilance practices to benefit public health. Maintain up-to-date knowledge of industry trends and regulatory changes. Qualifications Possess strong expertise in customer service within the pharmacovigilance domain. Demonstrate proficiency in regulatory intelligence and its application in drug safety. Have experience in regulatory affairs and research and development as a nice to have skill. Exhibit excellent communication skills in English both written and spoken. Show ability to work effectively in a hybrid work model with rotational shifts. Display a commitment to maintaining high standards of compliance and safety. Bring a proactive approach to problem-solving and process improvement. Certifications Required Certified Pharmacovigilance Professional Regulatory Affairs Certification - B.Pharm/M.Pharm

Group Purpose Global Regulatory Policy and Intelligence engages regulators, industry and professional associations, and patient advocates externally and subject matter experts across Amgen to advance important Regulatory policy issues aligned with Amgen’s goals and priorities. Regulatory Intelligence for the GRAAS organization enables fast, efficient global filings by effectively monitoring, analyzing, and communicating regulatory requirements to regulatory strategy leads and others involved in the delivery of regulatory submissions and approvals. Coordination of change management activities in response to major changes in regulation also falls within the remit of this organization. Job Summary Performs monitoring and analysis of the global regulatory landscape according to defined plans and priorities and delivers agreed regulatory intelligence outputs. The Technology Systems Manager will be responsible for creating, developing, and maintaining a comprehensive databases and systems to facilitate optimizing data resource platforms and systems to collect and disseminate relevant regulatory information to internal stakeholders, ensuring timely awareness and compliance. The ideal candidate will have a strong background in system analysis/administration, regulatory affairs and intelligence. Key Activities Facilitates and supports the tools and platforms utilized to prepare regulatory intelligence outputs that guide the successful development, submission and approval of Amgen products worldwide. Uses internal and external contacts, tools and systems to gather regulatory intelligence Applies professional skills and experience with advanced tools to summarize and contextualize regulatory intelligence information and identify trends in agency feedback Effectively communicates regulatory requirements to Regulatory Affairs staff Continually seeks opportunities to improve the usefulness of regulatory intelligence outputs and the effectiveness of tools and systems. Works with limited supervision according to predefined regulatory intelligence workplans Applies tools and systems to deliver agreed intelligence objectives Communicates progress and escalates issues impacting delivery of intelligence outputs Provides suggestions for improvement of processes, systems and tools employed within the function. Knowledge and Skills Basic: Regulatory intelligence monitoring, analyzing, and interpreting global regulatory developments to ensure compliance and inform strategic decision-making. Knowledge of regulatory agency guidelines and procedures (major and non-major markets) Knowledge of regulatory intelligence systems and platforms Understanding and application of aspects of global and local regulatory process Project management skills Presentation and interpersonal communication skills Preferred: Global Regulatory Intelligence monitoring experience Education and Experience (basic) Doctorate degree, OR Master’s degree and 3 years of directly related experience. OR Bachelor’s degree and 5 years of directly related experience, OR Associate’s degree and 10 years of directly related experience Education and Experience (preferred) A bachelor's degree in life sciences or a related field; advanced degrees may be preferred. A minimum of 5 years of experience in regulatory affairs, with at least 3 years in a regulatory intelligence role within the pharmaceutical, biotechnology, or medical device industries. In-depth knowledge of global regulatory frameworks and guidelines, such as those from the FDA, EMA, and other health authorities. Strong analytical and problem-solving skills, with the ability to interpret complex regulatory information and provide actionable insights. Excellent communication skills, both written and verbal, to effectively present information to diverse audiences. Proficiency with regulatory intelligence databases and software tools.

Manager of Regulatory Affairs for Biologicals at Eris Lifesciences Ltd. in Ahmedabad will be responsible for ensuring regulatory compliance and facilitating the approval of biological products including loan license. This role offers an exciting opportunity for individuals with 9-10 years of experience in regulatory affairs within the biopharmaceutical industry. Key Responsibilities: 1. Regulatory Strategy Development: Collaborate with cross-functional teams to develop and execute regulatory strategies for biological products, ensuring alignment with corporate objectives and regulatory guidelines. 2. Regulatory Submissions: Prepare and submit regulatory documents, including CDSCO dossiers/queries, variations including scale-up changes, and annual reports, while ensuring accuracy, completeness, and timeliness. 3. Regulatory Intelligence: Monitor and interpret regulatory requirements, guidelines, and trends related to biological products to inform decision-making and maintain compliance. 4. Cross-functional Collaboration: Work closely with R&D, Clinical Development, Quality Assurance, and Manufacturing teams to support regulatory activities, resolve regulatory issues, and facilitate product development and registration. 5. Regulatory Compliance: Ensure compliance with applicable regulations and guidelines, including those set forth by regulatory authorities such as the CDSCO, FDA, EMA, and other global agencies, throughout the product lifecycle. 6. Regulatory Agency Interactions: Serve as a primary point of contact for regulatory agencies, participating in meetings, teleconferences, and regulatory inspections as needed to address inquiries and facilitate approvals. 7. Product Labelling and Promotional Material Review: Review and approve product labelling, promotional materials, and advertising to ensure compliance with regulatory requirements and company policies. 8. Regulatory Document Management: Maintain regulatory files and documentation in accordance with company procedures and regulatory standards, ensuring accessibility and traceability. 9. Risk Management: Identify potential regulatory risks and develop mitigation strategies to address them proactively, while fostering a culture of compliance within the organization. 10. Training and Development: Provide training and guidance to internal stakeholders on regulatory requirements, processes, and best practices to enhance regulatory compliance awareness and capabilities. Qualifications: Bachelor's or Master's degree in a relevant scientific discipline (e.g., biology, pharmacy, chemistry) or regulatory affairs. 9-10 years of experience in regulatory affairs or quality assurance within the biopharmaceutical industry, with specific experience in biological products preferred (rDNA). Strong knowledge of regulatory requirements and guidelines for biological products, including CDSCO, FDA, EMA, and other global regulations. Experience in preparing and submitting regulatory documents and interacting with regulatory agencies. Excellent communication, interpersonal, and problem-solving skills. Ability to work effectively in a fast-paced, dynamic environment and manage multiple priorities simultaneously. Proven ability to collaborate cross-functionally and influence stakeholders at all levels of the organization.