Senior Manager / Regulatory Lead Global Regulatory Affairs

Why This Role Matters
The Senior Manager / Regulatory Lead plays a strategic leadership role in guiding global regulatory affairs activities within a Clinical Research Organization. This position is responsible for developing regulatory strategies, managing global submissions, and ensuring compliance with international regulatory requirements while supporting product approvals across multiple markets.

Job Description
The Senior Manager / Regulatory Lead will oversee regulatory strategy, dossier preparation, and submission management for clinical trials and pharmaceutical products. The role involves interacting with global regulatory authorities, leading regulatory teams, and ensuring compliance with international standards such as ICH, NDCTR, and GCP.

Key Features of the Role
• Leadership role in global regulatory strategy and submission management
• Exposure to regulatory agencies such as USFDA, EMA, CDSCO, MHRA, and GCC authorities
• Involvement in multi-country clinical trial and marketing authorization submissions
• Opportunity to lead and mentor regulatory affairs teams
• Strategic role in regulatory compliance and product lifecycle management

Responsibilities
• Develop and implement global regulatory strategies for clinical trials, marketing authorization, and product lifecycle management
• Lead preparation, review, and approval of regulatory dossiers including IND, CTA, MAA, ANDA, and NDA submissions
• Oversee eCTD compilation and regulatory submission management
• Act as the primary liaison with regulatory authorities such as CDSCO, USFDA, EMA, MHRA, and GCC regulatory agencies
• Provide strategic guidance on regulatory frameworks including NDCTR, ICH, and GCP guidelines
• Conduct regulatory risk assessments and develop mitigation strategies
• Lead and mentor regulatory affairs team members including managers, executives, and associates
• Support regulatory audits, due diligence activities, and inspection readiness programs
• Coordinate with cross-functional teams including Clinical Operations, Pharmacovigilance, and Quality Assurance

Required Qualifications

Educational Requirements:
• Master’s Degree in Pharmacy (M.Pharm), Doctor of Pharmacy (Pharm.D), or MSc in Regulatory Affairs / Life Sciences

Experience and Skills:
• Minimum 10+ years of core experience in Regulatory Affairs within pharmaceutical or CRO industries
• Strong expertise in global regulatory frameworks and submission pathways
• Proven experience handling regulatory authority queries and meetings
• Leadership experience in managing regulatory teams and cross-functional projects
• Knowledge of regulatory guidelines including NDCTR, ICH, and GCP
• Excellent documentation, analytical, and communication skills
• Strategic decision-making and regulatory risk assessment capabilities

Salary Insights:
• Salary offered as per industry norms depending on experience and expertise

Company Overview
Forward Life Pvt. Ltd. is a rapidly growing Clinical Research Organization providing services in clinical operations, pharmacovigilance, regulatory affairs, and quality management. The organization operates with global standards and supports pharmaceutical companies with regulatory strategy, clinical research, and compliance services.

FAQs
• What qualifications are required for this role?
Candidates should have M.Pharm, Pharm.D, or MSc in Regulatory Affairs or Life Sciences.

• How much experience is required?
Applicants should have at least 10+ years of experience in Regulatory Affairs.

• Where is the job located?
The position is based in Hyderabad, Telangana, India.

• What type of organization is offering this role?
The role is offered by a Clinical Research Organization (CRO).

Application Tips
• Highlight experience with global regulatory submissions and strategy development
• Mention experience interacting with regulatory authorities such as USFDA or EMA
• Showcase leadership and team management experience in regulatory affairs
• Include expertise in eCTD submissions and lifecycle management
• Demonstrate knowledge of global regulatory guidelines including ICH and NDCTR