Regulatory Manager – Labelling

Syneos Health

. Manage end-to-end CCDS updates based on confirmed safety signals .

Posted 10/27/2026full-timeHyderabad • IndiaSeniorLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive regulatory knowledge and experience in managing end-to-end CCDS updates, regulatory submissions, and project management within the pharmaceutical and medical device sectors. Proficient in providing strategic regulatory advice and leading cross-functional teams to ensure compliance and successful project execution.

Highest-signal resume keywords

Regulatory Submissions ManagementCCDS Updates ManagementProject ManagementRegulatory Knowledge in PharmaceuticalsExcellent Written and Verbal Communication

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsIND WritingPMA ExperienceNDA ExperienceMAA ExperienceCTD SubmissionsElectronic SubmissionsBudget ManagementQuality ManagementRegulatory Research

Soft Skills

Customer Service SkillsProblem-Solving SkillsDecision-Making SkillsPeople ManagementTeam Collaboration

Tools & Technologies

Microsoft Office Applications

Industry Keywords

Pharmaceutical DevelopmentMedical Device DevelopmentSafety SignalsHealth Authority ComplianceQuality ImprovementRegulatory Agency MeetingsProject BudgetsClient InvoicingNiche SubmissionsRegulatory Systems Development

Tech Stack

Tools & technologies

PMP

About the role

Key responsibilities & impact

Manage end-to-end CCDS updates based on confirmed safety signals
Lead cross-functional discussions and obtain CCDS approval through Safety Review Committees
Update CCDS based on clinical and non-clinical study results and abbreviated PIs
Manage EU QRDs for MRP/DCP/CP and USPIs for safety submissions
Handle PSUSA/PRAC and linguistic reviews
Drive labelling updates for ROW markets and artwork implementation
Follow up with regional teams and coordinate with QP release sites
Handle health-authority-mandated safety proposals and deviations
Plan regulatory submissions for assigned regions, countries, and projects
Manage project teams and projects day to day
Provide line management for staff, including hiring, development, goal setting, performance management, coaching, mentoring, and administrative oversight
Represent the regulatory department with other departments
Support business development, repeat business, and proposal development
Develop, review, and monitor project budgets and client invoicing
Monitor personal and direct-report utilization
Serve as a key contact for clients and regulatory authorities
Provide regulatory advice and strategic and operational advice to clients
Conduct regulatory research
Arrange, lead, and report on client and regulatory agency meetings
Write IND and product registration dossiers, clinical reports, and other regulatory documents
Manage regulatory submissions for INDs, product registrations, and post-approval maintenance
Provide technical knowledge and internal training
Participate in quality improvement and regulatory systems/infrastructure development
Promote the Company as a regulatory industry leader through events, articles, and industry association participation
Develop solutions to complex problems
Perform other assigned work-related duties

Requirements

What you’ll need

Minimum 8+ years of relevant experience
BS degree, preferably in a science-related field, or equivalent experience in science/regulatory/medical writing-related field or moderate pharmaceutical/medical device related experience
Moderate experience in regulatory
Demonstrated experience contributing to regulatory submissions, including IND, PMA, NDA, MAA, and CTD, including electronic submissions
Experience in niche submissions such as ODD and PIP/PMP is an advantage
Comprehensive regulatory knowledge and understanding of pharmaceutical and/or medical device product development
Excellent written and verbal communication skills
Excellent customer service skills and ability to work independently and as a team member
Good quality management and budgeting skills
Good people management, project management, problem-solving, and decision-making skills
Advanced skills in Microsoft Office Applications
Ability to interact with staff from multiple departments and offices to establish project standards
Initiative, adaptability, and pro-activity
Strong analytical skills and attention to detail
Ability to work concurrently on projects with differing instructions
Fluent in speaking, writing, and reading English

Benefits

Comp & perks

Career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition
Total rewards program
Inclusive culture
Minimal travel requirement (up to 25%)