Partner RA Regulatory Product Information Management Job At Astellas
The Partner, RA Regulatory Product Information Management role in Bengaluru offers an excellent opportunity for regulatory professionals to work in a strategic and execution-focused position within a global pharmaceutical organization. This Regulatory Affairs Job role focuses on regulatory data management, regulatory operations, and cross-functional collaboration with global health authorities and internal stakeholders. Graduates seeking B Pharma jobs or Pharmacy jobs can apply now.
Job Details
- Job Title: Regulatory Affairs Job
- Location: Bengaluru, IND
About the Company
Astellas is a global pharmaceutical company committed to equality of opportunity and responsible flexibility in the workplace. The organization collaborates across Regulatory Affairs, Pharmacovigilance, Marketing Operations, Data Science, Supply Chain, Manufacturing, and Medical & Development to deliver high-quality regulatory and healthcare outcomes worldwide.
Educational Requirements for Regulatory Affairs Job
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Bachelor’s degree in Pharmacy
Key Responsibilities for Regulatory Affairs Job
- Organize regulatory operations aspects of projects and products, including planning and tracking regulatory applications
- Ensure adherence to relevant submission standards and regulatory requirements
- Maintain relationships with global Regulatory Affairs stakeholders to resolve operational complexities and identify process improvements
- Support accuracy and completeness of global regulatory product data and metadata
- Performing or overseeing daily operations of Regulatory Information Management systems including data entry, quality control, and metrics is essential for this Regulatory Affairs Job role
- Create and support business processes to capture and track regulatory events
- Collaborate with RA stakeholders to provide regulatory information to internal and external systems
- Identify opportunities to align vocabulary management across RA systems
- Design and test reports sharing regulatory information with cross-functional stakeholders
- Support generation and transmission of data-centric regulatory submissions such as XEVMPD and IDMP
- Participate in project teams and task forces with increasing responsibility
Skills Required for Regulatory Affairs Job
- Minimum three years of experience in the pharmaceutical industry with regulatory operations exposure
- Ability to work independently and within cross-functional project teams
- Proven ability to prioritize and multitask with minimal supervision
- Strong written and verbal communication skills in English
- Ability to maintain confidentiality and proprietary information
- Ability to remain calm under pressure
- Experience with regulatory IT systems, document management, submission publishing, and registration management preferred
- Basic understanding of data governance, structured data constructs, and reporting platforms
- Proficiency in additional languages such as Japanese, Spanish, French, or Chinese preferred
Why This Job Role?
This Regulatory Affairs Job role offers the opportunity to work in a global regulatory environment, gain exposure to advanced regulatory data systems, and collaborate with international health authorities while benefiting from Astellas’ hybrid working model and commitment to work-life balance. Graduates seeking B Pharma jobs or Pharmacy jobs can apply now.
