Life Sciences Regulatory Services Specialist
Role Level: Team Lead / Consultant
Location: Bengaluru, India
Job Type: Full-Time
Experience Required: 7–11 Years
Job ID: AIOC-S01620287
Job Overview
We are seeking a Life Sciences Regulatory Services Specialist to lead and manage regulatory compliance and submissions for global biopharmaceutical clients. This role is ideal for professionals with extensive experience in regulatory operations, electronic submissions, and global lifecycle management, who are looking to contribute to strategic regulatory initiatives in a high-impact, client-focused environment.
As a regulatory services leader, you will ensure timely and compliant submission of global regulatory filings, including CMC, Ad-promotional materials, amendments, annual reports, SPL submissions, and other Life Cycle Management (LCM) activities. You will collaborate with cross-functional teams to maintain regulatory compliance, streamline operational processes, and support strategic regulatory goals.
Key Responsibilities
Regulatory Submissions & Compliance
Coordinate and manage essential documentation for global regulatory filings
Prepare, review, and submit electronic and paper applications, ensuring compliance with applicable laws, regulations, and client SOPs
Support Life Cycle Management (LCM) submissions including amendments, annual reports, and promotional material filings
Ensure accuracy and completeness of submissions to regulatory authorities
Analysis & Problem Solving
Analyze and resolve moderately complex regulatory challenges using established methods and industry best practices
Develop new solutions or adapt existing processes to meet client needs and regulatory requirements
Identify gaps and recommend improvements to enhance compliance and efficiency
Team Leadership & Collaboration
Manage small teams or coordinate work efforts, ensuring alignment with client goals and organizational strategy
Provide guidance to junior team members and support cross-functional collaboration
Interact with peers, client stakeholders, and management to deliver regulatory solutions effectively
Strategic Contribution
Align regulatory activities with strategic direction and client objectives
Maintain awareness of global regulatory changes and ensure team adherence to new requirements
Drive process improvements and productivity initiatives while staying within client agreements and compliance guidelines
Required Qualifications
Bachelor of Pharmacy (B.Pharm) – required
7–11 years of experience in life sciences regulatory operations, clinical submissions, or pharmaceutical compliance
Hands-on experience with global regulatory submissions and electronic submission platforms
Strong knowledge of regulatory guidelines, compliance standards, and submission processes (FDA, EMA, ICH)
Experience managing or mentoring small teams, coordinating multiple priorities, and working with cross-functional stakeholders
Excellent analytical, problem-solving, and communication skills
Core Competencies
Deep understanding of life sciences regulatory operations
Ability to lead regulatory submissions with accuracy and timeliness
Strong project management and organizational skills
Experience in electronic submissions and document management systems
Strategic thinking with attention to detail and regulatory compliance
Why Join This Role?
Work with global biopharma clients on high-impact regulatory programs
Lead regulatory submissions and lifecycle management activities that directly impact patient access and safety
Opportunity to mentor teams and influence regulatory operations at a global scale
Exposure to strategic initiatives and process improvements in a leading global professional services organization
SEO & GEO Keywords
Life Sciences Regulatory Specialist India, Regulatory Operations Team Lead Bengaluru, Global Regulatory Submission Jobs, B.Pharm Regulatory Consultant, Life Cycle Management Regulatory Jobs, Biopharma Regulatory Compliance Careers
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