Senior Manager / Manager - Regulatory Affairs (Clinical Research)

Why This Role Matters
The Senior Manager / Manager – Regulatory Affairs plays a vital role in guiding regulatory strategies and managing global submissions within a Clinical Research Organization (CRO). This position ensures that clinical and pharmaceutical products comply with international regulatory standards while supporting successful approvals across multiple global markets.

Job Description
The Regulatory Affairs Manager will lead regulatory documentation, submission strategies, and lifecycle management activities for clinical research and pharmaceutical products. The role involves preparing regulatory dossiers, interacting with global health authorities, and coordinating with cross-functional teams to ensure regulatory compliance and timely product approvals.

Key Features of the Role
• Leadership role within the regulatory affairs function of a CRO
• Exposure to global regulatory markets including USFDA, EMA, CDSCO, MHRA, and TGA
• Involvement in regulatory strategy development and dossier submissions
• Opportunity to mentor junior regulatory professionals
• Collaborative work with clinical, quality, and medical writing teams

Responsibilities
• Prepare, review, and submit regulatory dossiers including IND, CTA, ANDA, and Marketing Authorization applications
• Manage regulatory submissions for global markets such as USFDA, EMA, CDSCO, MHRA, TGA, and GCC regions
• Develop regulatory strategies for clinical trials and product lifecycle management
• Coordinate with cross-functional teams including Clinical Operations, QA, Manufacturing, and Medical Writing
• Handle regulatory authority queries and prepare deficiency responses
• Ensure compliance with NDCTR, ICH, GCP, and global regulatory guidelines
• Support preparation for regulatory authority meetings and maintain submission documentation
• Mentor and guide junior regulatory affairs team members
• Monitor regulatory updates and implement changes in submission strategies

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:
• 5–10 years of experience in Regulatory Affairs within pharmaceutical or CRO industries
• Strong knowledge of global clinical trial and marketing authorization pathways
• Experience with eCTD compilation and publishing
• Understanding of regulatory frameworks including ICH, NDCTR, and GCP guidelines
• Excellent documentation, analytical, and communication skills
• Leadership capability and experience in mentoring teams
• Strong problem-solving and regulatory risk assessment skills

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

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 company focuses on delivering high-quality research solutions while maintaining global regulatory standards and professional ethics.

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 5–10 years of relevant experience in regulatory affairs.

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

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

Application Tips
• Highlight experience with global regulatory submissions and dossier preparation
• Mention knowledge of eCTD publishing and regulatory pathways
• Include experience interacting with regulatory authorities
• Showcase leadership experience and team management skills
• Demonstrate understanding of global regulatory guidelines such as ICH and GCP