Lead I - Business Analysis

5 - 7 Years
2 Openings
Bangalore, Hyderabad

Job Title:

Life Sciences Regulatory Affairs (RA) Associate – Publishing

Job Summary:

We are looking for a skilled and experienced Regulatory Affairs Associate – Publishing to join our Life Sciences Practice. The ideal candidate will support global regulatory submission activities by managing electronic publishing (document-level and submission-level), collaborating with cross-functional teams, and ensuring compliance with international regulatory standards throughout the product lifecycle.

This role requires a blend of business analysis acumen, strong communication skills, stakeholder engagement, and hands-on expertise with regulatory publishing tools and systems.

Key Responsibilities:

Regulatory Publishing & Documentation:

• Compile, format, and publish regulatory submissions including but not limited to INDs, NDAs, BLAs, MAAs, ANDAs, CTAs, DMFs, 510(k), PMAs, CE Marking documents, and other regional submissions (FDA, EMA, Health Canada, MHRA, RoW).

• Ensure adherence to eCTD/NeeS and regional submission formats using tools such as Lorenz DocuBridge, Veeva Vault, and Extedo.

• Conduct document-level and submission-level publishing with full version control, metadata tagging, hyperlinking, and bookmarking.

• Perform detailed quality control (QC) checks and validation of regulatory submissions to meet global standards.

• Ensure compliance with regulatory submission gateways (e.g., ESG, IRIS, CTIS), manage submission archives, and track dispatches.

Stakeholder Engagement & Collaboration:

• Liaise with internal and external stakeholders (RA, Clinical, CMC, QA, PV, Manufacturing, etc.) to gather and finalize documents for submission.

• Collaborate with cross-functional teams to define submission requirements, resolve issues, and align on publishing timelines.

• Lead stakeholder communications by adapting technical content for clear understanding and informed decision-making.

Business Analysis & Process Optimization:

• Analyze and define regulatory business needs; proactively identify gaps, risks, and opportunities for submission process improvement.

• Leverage tools and templates for requirements gathering, change control, document management, and impact assessments.

• Participate in continuous process improvement, recommending enhancements in publishing workflows and systems.

• Develop and maintain reusable artifacts, templates, and documentation standards across projects.

Compliance & Standards:

• Maintain up-to-date knowledge of regulatory guidelines (ICH, FDA, EMA, EU MDR, etc.).

• Support audits and inspections by ensuring documentation readiness and submission traceability.

• Ensure submissions meet organizational and global health authority standards.

Expected Outcomes & Measures of Success:

• Timely and accurate regulatory submissions with zero non-compliance issues.

• Effective communication and collaboration with stakeholders across functions and geographies.

• Business value contribution through process innovation, documentation standardization, and reuse of tools/artifacts.

• Positive customer and stakeholder feedback on submission quality and engagement.

• Continuous upskilling in relevant tools, regulations, and business analysis methodologies.

Required Qualifications & Experience:

• Graduate/Postgraduate in Pharmacy, Life Sciences, or related field.

• 4–6 years of experience in Regulatory Publishing (document and submission level).

• Hands-on expertise in publishing tools like Lorenz DocuBridge, Veeva Vault, Extedo, and eCTD validation tools.

• Strong understanding of global submission standards (eCTD, NeeS), electronic gateways (ESG, IRIS, etc.), and version control practices.

• Familiarity with RIM, DMS, and regulatory tracking systems.

• Knowledge of regulatory affairs across the product lifecycle—pre and post-marketing submissions, license maintenance, variations, renewals.

Desirable Skills & Competencies:

Business Analysis Competencies:

• Proven ability to elicit, document, and manage regulatory requirements.

• Experience in conducting stakeholder interviews, document analysis, impact assessments, and gap analyses.

• Strong analytical and problem-solving capabilities to evaluate solution options and provide recommendations.

• Familiarity with BA techniques (process modeling, root cause analysis, stakeholder mapping, etc.).

Soft Skills:

• Excellent communication (written and verbal), interpersonal, and collaboration skills.

• Strong time management and organizational skills.

• High degree of accountability, adaptability, and attention to detail.

Tools & Technologies:

• Experience using BA tools and platforms: JIRA, Confluence, MS Visio, SharePoint, Excel (advanced), etc.

• Proficiency in document control systems, submission archiving tools, and publishing platforms.

Additional Responsibilities (as required):

• Support junior team members and participate in mentoring activities.

• Assist in identifying new business opportunities and contribute to pre-sales/regulatory solutions, as requested by leadership.

• Participate in internal knowledge-sharing sessions, BA/RA CoEs, and training activities.

Location & Work Environment:

• Flexible work environment with hybrid/remote options based on project/client requirements.

• May require occasional travel for stakeholder workshops or audits.

Regulatory Affairs, Publishing,Lorenz DocuBridge, Veeva Vault, Extedo,Quality Management System