Job Type: Full Time, Hybrid, Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Regulatory Affairs, Regulatory Writing, Regulatory Compliance, Global Submissions, eCTD, IND/NDA/BLA Submissions, ICH-GCP, Regulatory Strategy, Regulatory Intelligence, Labeling Strategy.

Job Title: Regulatory Senior Consultant Discover more Pharmaceutical Pharmaceuticals & Biotech Job Company: Syneos Health Location: Gurugram, India (Hybrid) Job ID: 25107708 Employment Type: Full-time Department: Clinical Solutions – Regulatory Affairs Experience Required: 8+ years of experience in Regulatory Affairs with strong expertise in CMC regulatory submissions, CTD/eCTD documentation, post-approval variations, and lifecycle management activities.

Education: Master’s degree in Pharmacy (M.Pharm) or equivalent qualification in Pharmaceutical Sciences, Life Sciences, or related field. Discover more Company News Manager Consulting Compensation &

Advantages Pharmacy Business & Corporate Law Salary Package: ₹20–35 LPA (Estimated as per current market standards for Regulatory Senior Consultant roles in India; final compensation depends on regulatory expertise, therapeutic experience, market exposure, and interview performance.) Role Summary The Regulatory Senior Consultant will independently manage regulatory activities, support global submissions, provide regulatory strategy expertise, and ensure compliance with global health authority requirements across product development and lifecycle management activities.

Key Responsibilities Regulatory Submission Management Prepare and manage regulatory submissions for global markets.

Support

IND submissions

NDA/MAA submissions

CTD/eCTD dossiers

Post-approval variations

Lifecycle management activities

Conduct regulatory research and gap assessments based on global requirements.

Prepare regulatory strategies, submission plans, and product development documents.

CMC Regulatory Expertise Author and review CMC Module 3 sections for regulatory submissions.

Support CMC documentation for

New product registrations

Post-approval changes

Regulatory maintenance activities

Ensure compliance with regional regulatory expectations.

Regulatory Agency Interaction Prepare briefing packages for regulatory agency meetings.

Support scientific advice meetings and health authority interactions.

Provide regulatory input during cross-functional project discussions.

Address regulatory queries and provide strategic recommendations. Project & Stakeholder Management Manage day-to-day regulatory activities according to:

Project timelines

Scope

Budget requirements

Regulatory strategies

Collaborate with

Clinical teams

CMC teams

Medical writing teams

Quality teams

Global regulatory stakeholders

Act as a regulatory subject matter expert for project teams.

Quality & Compliance Ensure adherence to:

Global regulatory guidelines

Company SOPs

Quality management systems





Support regulatory audits and inspection readiness activities.

Develop SOPs, process documents, and regulatory best practices.

Maintain training records and complete required compliance training.

Required Technical Skills Regulatory Affairs Management

CMC Module 3 Authoring

CTD/eCTD Submissions

IND/NDA/MAA Regulatory Documentation

Post-Approval Variations

Lifecycle Management

Regulatory Strategy Development

Health Authority Interactions

Global Regulatory Guidelines

EU Regulatory Affairs

GCC Market Regulatory Experience

Pharmaceutical Product Development Knowledge Preferred Market Experience European Union (EU) Regulatory Submissions

GCC Regulatory Markets

Global Pharmaceutical Submissions

Complex and Non-complex Regulatory Applications Qualification Requirements Master’s degree in Pharmacy (M.Pharm) preferred.

Strong pharmaceutical regulatory experience.

Experience in preparation and review of technical regulatory documents.

Excellent written and verbal communication skills.

Strong analytical and problem-solving abilities.

Ability to manage multiple projects independently.

Key Competencies

Regulatory strategy mindset

Attention to detail

Stakeholder management

Client-facing communication

Project management skills

Quality-focused approach

Ability to work independently in a global environment Work Location Gurugram, India (Hybrid) About Syneos Health Syneos Health is a global life sciences organization providing clinical development and commercialization solutions. The company supports pharmaceutical and biotechnology organizations across the drug development lifecycle, helping accelerate delivery of innovative therapies to patients.

Job Title: Regulatory Senior Consultant Discover more Pharmaceutical Pharmaceuticals & Biotech Job Company: Syneos Health Location: Gurugram, India (Hybrid) Job ID: 25107708 Employment Type: Full-time Department: Clinical Solutions – Regulatory Affairs Experience Required: 8+ years of experience in Regulatory Affairs with strong expertise in CMC regulatory submissions, CTD/eCTD documentation, post-approval variations, and lifecycle management activities.

Education: Master’s degree in Pharmacy (M.Pharm) or equivalent qualification in Pharmaceutical Sciences, Life Sciences, or related field. Discover more Company News Manager Consulting Key Responsibilities Regulatory Submission Management Prepare and manage regulatory submissions for global markets.

Support

IND submissions

NDA/MAA submissions

CTD/eCTD dossiers

Post-approval variations





Lifecycle management activities

Conduct regulatory research and gap assessments based on global requirements.

Prepare regulatory strategies, submission plans, and product development documents.

CMC Regulatory Expertise Author and review CMC Module 3 sections for regulatory submissions.

Support CMC documentation for

New product registrations

Post-approval changes

Regulatory maintenance activities

Ensure compliance with regional regulatory expectations.

Regulatory Agency Interaction Prepare briefing packages for regulatory agency meetings.

Support scientific advice meetings and health authority interactions.

Provide regulatory input during cross-functional project discussions.

Address regulatory queries and provide strategic recommendations. Project & Stakeholder Management Manage day-to-day regulatory activities according to:

Project timelines

Scope

Budget requirements

Regulatory strategies

Collaborate with

Clinical teams

CMC teams

Medical writing teams

Quality teams

Global regulatory stakeholders

Act as a regulatory subject matter expert for project teams.

Quality & Compliance Ensure adherence to:

Global regulatory guidelines

Company SOPs

Quality management systems

Support regulatory audits and inspection readiness activities.

Develop SOPs, process documents, and regulatory best practices.

Maintain training records and complete required compliance training.

Required Technical Skills Regulatory Affairs Management

CMC Module 3 Authoring

CTD/eCTD Submissions

IND/NDA/MAA Regulatory Documentation

Post-Approval Variations

Lifecycle Management

Regulatory Strategy Development

Health Authority Interactions

Global Regulatory Guidelines

EU Regulatory Affairs

GCC Market Regulatory Experience

Pharmaceutical Product Development Knowledge Preferred Market Experience European Union (EU) Regulatory Submissions

GCC Regulatory Markets

Global Pharmaceutical Submissions

Complex and Non-complex Regulatory Applications Qualification Requirements Master’s degree in Pharmacy (M.Pharm) preferred.

Strong pharmaceutical regulatory experience.

Experience in preparation and review of technical regulatory documents.

Excellent written and verbal communication skills.

Strong analytical and problem-solving abilities.

Ability to manage multiple projects independently.

Key Competencies

Regulatory strategy mindset

Attention to detail

Stakeholder management

Client-facing communication

Project management skills

Quality-focused approach

Ability to work independently in a global environment Work Location Gurugram, India (Hybrid) About Syneos Health Syneos Health is a global life sciences organization providing clinical development and commercialization solutions. The company supports pharmaceutical and biotechnology organizations across the drug development lifecycle, helping accelerate delivery of innovative therapies to patients.

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