PHARMAFull-time
Manager, RA Publishing & Submissions
BANGALORE (IN)ONSITEPOSTED: 9/19/2026
PHARMAFull-time
HIRING ORGANIZATIONASTELLASPharmaceuticals and Life Sciences
ROLE OVERVIEW
Manager-level Regulatory Affairs Publishing & Submissions role focused on global regulatory submissions, publishing operations, submission standards, quality control and regulatory operations.
ROLE DEFINITION & RESPONSIBILITIES
- •Manage planning and preparation of regulatory submissions
- •track correspondence, applications and structured regulatory data
- •ensure adherence to submission standards and regulatory pathways
- •provide interpretation of regulatory guidance and directives
- •train staff on systems and processes
- •manage global submission publishing and archiving
- •support affiliates and business partners
- •execute electronic document and submission quality control
- •coordinate submission timelines and content plans with RAPV and vendors
- •maintain filing-status communications
- •contribute as a subject matter expert to project teams
- •represent Publishing & Submission functions in regulatory authority meetings when required.
Reporting Hierarchy: Specific reporting manager is not stated; collaborates with RAPV, Project Management, publishing vendors, affiliates, business partners and other Astellas functions.
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Bachelor's degree, preferably in science or technology
- at least 3 years of pharmaceutical industry experience with some regulatory operations experience
- ability to work independently and within project teams
- strong written and verbal English communication
- ability to prioritize and multitask
- high integrity and confidentiality.
PREFERRED QUALIFICATIONS
- •Advanced degree such as Master's or PhD
- •IT systems or business operations support experience
- •experience with document management, submission publishing, registration management, labeling or change control systems
- •understanding of information taxonomies and master data management
- •understanding of data warehousing, data lakes and analytics platforms
- •additional language proficiency.
REQUIRED VERIFIED SKILLS
Regulatory submissions; regulatory operations; submission publishing; regulatory compliance; electronic document management; quality control; project coordination; regulatory guidance interpretation; vendor management; training; communication; multitasking
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Global collaboration, patient impact, innovation, professional development and growth opportunities
Salary is not disclosed in the supplied posting.
ORGANIZATION CONTEXT & CULTURE
Astellas is a global life sciences company focused on innovative therapies in areas including oncology, ophthalmology, urology, immunology and women's health.
TEAM SIZE: Large global life sciences company
INDUSTRY: Pharmaceuticals and Life Sciences
Culture: Innovation, integrity and impact are stated organizational values; the company emphasizes global collaboration, accountability, courage, urgency and outcome focus.
EXPECTED CAREER ROADMAP
Potential progression into regulatory operations leadership, publishing and submission management, regulatory systems, or broader Regulatory Affairs roles.
APPLICATION ADVISORY
Highlight 3+ years of pharmaceutical and regulatory operations experience, submission publishing expertise, project coordination, regulatory standards knowledge, system experience and strong English communication.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
Verify your capability profile and matching credentials before submitting direct applications.