Deputy Manager, Regulatory Affairs

RXinsider LTD.; Ahmedabad District; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

RXinsider LTD. in Ahmedabad, India, is seeking a senior Regulatory Affairs professional to lead dossier compilation for US, EU, and Canada, and to develop regulatory strategies for complex injectable products. You will coordinate with cross-functional teams to ensure timely submissions and readiness for inspections.

The ideal candidate has 8+ years in regulatory affairs, holds a B. Pharm (M. Pharm preferred), and demonstrates strong knowledge of FDA, EMA, and ICH guidelines.

Qualifications

• 8 years or more in regulatory affairs.
• Experience with US FDA and EU EMA submissions for regulated markets.
• Develop regulatory strategies for complex injectable products.
• Coordinate with stakeholders for documentation required for modules 1–3.
• Lead regulatory strategy for 505(b)(2) and NDA positioning.
• Support regulatory impact assessments for CMC changes and change control.

Responsibilities

• Lead and manage regulatory workload planning for regulated market programs.
• Drive dossier compilation for complex injectable products/high‑impact submissions.
• Ensure document control, version governance, and cross‑functional alignment.
• Monitor regulatory intelligence and implement updates into strategies.
• Lead cross-functional team communications and submission traceability.
• Apply risk identification and mitigation across regulatory programs.

Skills

Regulatory affairs

Dossier compilation

Regulatory strategy

Leadership

FDA knowledge

CMC changes

Documentation control

Risk assessment

Submission management

Regulatory intelligence

Education

B. Pharm

M. Pharm

Job description

Job Description

Primary Responsibilities (Key Accountabilities)

• Dossier Compilation & Submission (US/EU/Canada)


• Lead compilation, review, and finalization of dossiers for regulated markets, primarily for US (ANDA/505(b)(2) and, EU for injectable products.


• Develop and finalize regulatory strategies for new product development (complex injectable product).


• Coordinate with stakeholders to obtain/verify documentation required for Modules 1–3.


• Provide hands‑on leadership for 505(b)(2) application strategy, including identification of reliance approach, bridging requirements, PIND meeting submissions and NDA positioning to support approval.


• Support regulatory impact assessment for CMC changes and ensure compliance with internal change control and global filing requirements.


• Author and coordinate responses to FDA/EMA deficiency letters/queries, ensuring scientifically justified, traceable, and timely responses.


• Support inspection/audit readiness (including DMF support where applicable) by ensuring traceability, data integrity, and submission correctness.


• Plan workload, mentor junior team members, and ensure high standards for document quality, formatting, and technical consistency across submissions.


• Regulatory Intelligence & Guidance Interpretation


• Maintain up‑to‑date knowledge of FDA guidance, ICH guidelines, EU requirements, and relevant public domain information; assess impact on ongoing and future submissions and translate updates into actionable changes


• Provide input to regulatory strategy and risk assessments based on evolving regulatory expectations and trends.

Essential Functions

• Lead and manage regulatory workload planning, prioritization, and performance delivery for regulated market programs.


• Drive dossier compilation for complex injectable products/high‑impact submissions and ensure first cycle approvals


• Ensure strong document control, version governance, and cross‑functional document alignment.


• Monitor regulatory intelligence and implement necessary updates into strategies and documentation standards.


• Lead CFT communications (queries, commitments, and follow‑ups) and maintain submission traceability.


• Apply risk identification and mitigation across regulatory programs to reduce approval delays.

Education

QUALIFICATIONS

• B. Pharm B. Pharm - Required


• M. Pharm M. Pharm - Preferred

Experience:

• 8 years or more in 8 - 10 Years