PHARMAFull-time
Seniorr Associate Regulatory Writing
By Admin · Medical & Scientific Writing
HYDERABAD (IN)ONSITEPOSTED: 9/17/2026
PHARMAFull-time
HIRING ORGANIZATIONAMGENBiotechnology / Pharmaceuticals
ROLE OVERVIEW
Independently author and manage routine to moderately complex regulatory documents while coordinating reviews, ensuring scientific accuracy, inspection readiness and timely delivery across cross-functional teams.
ROLE DEFINITION & RESPONSIBILITIES
- •Author routine to moderately complex regulatory documents including ICFs, PLPS, CSR sections, protocol amendments and IB updates
- •Manage document versions, reviewer comments and approval workflows end to end
- •Ensure scientific accuracy and consistency with source data and program intent
- •Prepare documents for QC and inspection readiness according to guidance documents and SOPs
- •Support audits and inspections with document history and rationale
- •Coordinate with Clinical, Safety, Regulatory and Study teams to resolve inputs and comments
- •Track deliverables and timelines and escalate risks, scope changes or timeline pressures
- •Participate in training, knowledge-transfer sessions and process improvement activities
Reporting Hierarchy: Reports to Regulatory Writing management; Collaborates with Clinical, Safety, Regulatory and Study teams and coordinates document reviewers and approvers
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Relevant experience in regulatory writing
- Ability to independently author routine to moderately complex clinical and regulatory documents
- Strong scientific writing and document management skills
- Cross-functional stakeholder management and communication skills
- Ability to manage multiple deliverables and timelines
- Knowledge of document management systems, RIM tools, SharePoint and authoring platforms
PREFERRED QUALIFICATIONS
- •Experience with clinical study documents such as CSRs, protocols, ICFs, PLPS and Investigator's Brochures
- •Experience supporting regulatory audits or inspections
- •Experience with RIM systems and regulated document workflows
- •Experience in pharmaceutical or biotechnology environments
REQUIRED VERIFIED SKILLS
Regulatory Writing
Scientific Writing
Clinical Documents
ICF
PLPS
Clinical Study Reports
CSR
Protocol Amendments
Investigator's Brochure
Document Management
Quality Control
Inspection Readiness
SOP Compliance
RIM Tools
SharePoint
Stakeholder Management
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Standard benefits may include health insurance, paid leave, retirement benefits and employee wellbeing programs; specific benefits are not disclosed in the supplied posting.
No salary or numerical compensation information is disclosed in the supplied posting. No compensation figures have been inferred.
ORGANIZATION CONTEXT & CULTURE
Amgen is a biotechnology company that discovers, develops, manufactures and delivers innovative medicines, combining biology, technology and human genetic data to address serious diseases.
TEAM SIZE: 30,000+ employees
INDUSTRY: Biotechnology / Pharmaceuticals
Culture: Amgen emphasizes scientific innovation, cross-functional collaboration, accountability and equal opportunity, with a focus on developing medicines that improve patients' lives.
EXPECTED CAREER ROADMAP
The role can provide progression into Regulatory Writing management, senior regulatory writing roles, regulatory submission strategy, or broader regulatory affairs and clinical documentation leadership positions.
APPLICATION ADVISORY
Highlight hands-on regulatory writing experience and examples of independently authored documents; showcase experience with CSRs, protocols, ICFs, PLPS or IBs; emphasize document lifecycle and reviewer-comment management; demonstrate inspection readiness and SOP compliance; mention RIM, SharePoint and authoring-platform experience; highlight cross-functional communication and consistent on-time delivery.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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