Job Title: Partner – Regulatory Affairs (RA) Regulatory Product Information Management
Location: Bengaluru, India (Hybrid)
Experience Required: 3–6 Years
Job Type: Full-Time
Astellas Pharma is seeking a skilled Partner – Regulatory Affairs (RA), Regulatory Product Information Management to support the global regulatory operations of its pharmaceutical portfolio. This strategic role involves managing regulatory product data, ensuring compliance with local and global regulations, and driving process improvements across regulatory functions. The position offers the opportunity to collaborate with multiple global teams, including Pharmacovigilance, Medical Affairs, Marketing Operations, Data Science, Supply Chain, and Development Operations.
The role also includes contributing to critical project teams and task forces, ensuring accurate regulatory information supports effective decision-making across the organization.
Ensure the accuracy, completeness, and quality of global regulatory product data, metadata, and associated regulatory information in collaboration with data owners.
Perform or oversee daily operations of the global Regulatory Information Management system, including data entry, quality control, and reporting metrics.
Develop and maintain business processes to capture, track, and manage regulatory events and information in line with local and international regulatory requirements.
Collaborate with Regulatory Affairs stakeholders to provide regulatory information to integrated systems across the organization.
Identify opportunities to standardize vocabulary management across RA systems, in partnership with the Data Governance and Compliance teams.
Design, generate, and test reports that share regulatory information with cross-functional teams, including Pharmacovigilance, Medical Affairs, Finance, Development Operations, and senior management.
Support regulatory data-centric submissions, such as XEVMPD and IDMP, ensuring timely and accurate delivery.
Maintain high confidentiality and integrity in handling proprietary regulatory information.
Bachelor’s degree in Science, Technology, Pharmacy, or Life Sciences.
Minimum 3 years of experience in the pharmaceutical industry with exposure to regulatory operations or regulatory information management.
Proven ability to work independently and within cross-functional teams, prioritizing multiple tasks with minimal supervision.
Strong written and verbal communication skills in English.
Ability to manage confidential information with high integrity and maintain composure under pressure.
Advanced degree (Master’s, PhD, or equivalent).
At least 6 years of experience in regulatory operations or a related role.
Experience with regulatory IT systems, document management, submission publishing, registration management, labeling, and change control systems.
Knowledge of information taxonomies, master data management, and structured data concepts.
Familiarity with data warehousing, data lakes, and reporting/analytics platforms.
Proficiency in additional languages (Dutch, Japanese, Spanish, Portuguese, French, Russian, Chinese) is a plus.
Astellas offers a hybrid working model, combining office collaboration with the flexibility of remote work to optimize productivity. Travel may be required occasionally depending on project needs. The role is based in Bengaluru, India, with adherence to Astellas’ Responsible Flexibility Guidelines.
Astellas Pharma is a global pharmaceutical company committed to improving patient health through innovative therapies. The company values a diverse, inclusive, and collaborative work culture, providing opportunities for professional growth, skill development, and impactful contributions to global healthcare.
Equal Opportunity Employer:
Astellas is committed to equality of opportunity, including for individuals with disabilities and protected veterans.
Apply Now: Submit your application to join a global leader in pharmaceutical innovation and regulatory excellence.
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