Deputy Manager – Regulatory Affairs (Complex & 505(b)(2) Products)
Location: Ahmedabad, Gujarat, India
Employment Type: Full-Time
Experience Required: 12+ years overall, including 8–10 years in Regulatory Affairs for injectable or complex products
Education: M.Pharm / PhD (Regulatory Affairs or Pharmaceutics specialization preferred)
Application Deadline: 28 February 2026
Position Overview
A leading pharmaceutical organization is seeking a Deputy Manager – Regulatory Affairs to manage complex product portfolios, including injectables (peptides, microspheres, liposomes, nano-suspensions), ophthalmic, otic, topical gels, DDCP products, and 505(b)(2) filings for the US and EU markets. The role involves end-to-end regulatory strategy development, submission preparation, and cross-functional collaboration to ensure timely approvals and compliance with global regulatory standards.
Key Responsibilities
Regulatory Strategy & Submission
Prepare, review, and finalize regulatory strategies for complex and 505(b)(2) products for US and EU markets.
Draft and finalize Pre-ANDA, Pre-IND, and ScA meeting packages.
Prepare controlled correspondence and respond to complex regulatory queries.
Draft, review, and finalize deficiency responses to US and EU authorities.
Review API and finished product in-vitro characterization and sameness reports.
Conduct DMF reviews for complex APIs and ensure alignment with regulatory requirements.
Cross-Functional Collaboration
Work closely with R&D, Quality, Manufacturing, and other cross-functional teams to ensure regulatory compliance throughout product development and submission.
Provide regulatory guidance and training to team members on complex products and evolving regulatory requirements.
Actively contribute as a team member in matrixed organizations, ensuring high-quality outcomes aligned with corporate priorities.
Quality, Compliance & Process Excellence
Apply critical thinking and regulatory expertise to ensure compliance with US and EU regulatory guidelines.
Maintain high standards of integrity, quality, and accountability in all regulatory submissions.
Exercise sound judgment on regulatory, quality, and technical compliance matters.
Promote solutions-oriented approaches and ensure timely execution of deliverables.
Required Skills & Competencies
End-to-end regulatory knowledge of complex products for US/EU markets, including strategy, filing, and deficiency management.
Strong expertise in injectable dosage forms and 505(b)(2) products.
Experience drafting controlled correspondence, meeting packages, and regulatory strategies.
Ability to work collaboratively in cross-functional and matrixed teams.
Excellent analytical, problem-solving, and critical thinking skills.
Strong communication skills with the ability to interface effectively with domestic and international stakeholders.
High personal integrity, accountability, and compliance mindset.
Qualifications & Experience
Master’s or PhD in Pharmacy (Regulatory Affairs or Pharmaceutics specialization preferred).
Minimum of 8–10 years in Regulatory Affairs for injectable/complex products.
12+ years overall experience in pharmaceutical regulatory affairs.
Proven experience managing US and EU regulatory submissions for complex and 505(b)(2) products.
Why Join?
This role provides a strategic opportunity to lead regulatory activities for complex products in a global pharmaceutical organization. You will contribute to regulatory strategy, ensure compliance with FDA and EMA requirements, and collaborate across R&D, Quality, and Manufacturing teams. This position offers professional growth, exposure to high-impact projects, and a platform to influence regulatory decision-making on a global scale.
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