Senior General Manager

Rubicon Research Limited; Thane; On-site; INR 2,500,000 - 3,500,000; Full time

Job summary

Rubicon Research Limited is looking for a Senior General Manager / General Manager in Regulatory Affairs. This role focuses on leading regulatory efforts for pre-approval submissions in the US market, requiring over 20 years of experience. Responsibilities include preparing regulatory strategies, managing submissions, interacting with regulatory bodies, and ensuring operational excellence. The ideal candidate should possess strong leadership and analytical skills, and familiarity with USFDA processes is essential. This position may require working in different shifts.

Qualifications

• 20+ years of experience in regulatory affairs and pharmaceutical development.
• Excellent leadership and analytical skills.
• Experience managing over 100 submissions annually.

Responsibilities

• Lead regulatory strategies for the US market.
• Review and submit quality dossiers including ANDAs and NDAs.
• Plan and manage all pre-approval submissions.
• Interact with regulatory agencies and stakeholders.

Skills

Regulatory Affairs

Pharmaceutical Development

Leadership

Analytical Skills

Communication

Interpersonal Skills

Planning

Experience with USFDA

Job description

Purpose

This position will lead and be accountable for the pre‑approval regulatory efforts in the US market.

Position / Job Title

Senior General Manager / General Manager

Department

Regulatory Affairs

Reporting To

Director – Regulatory Affairs & IP

Location

Thane

Years of Experience

20+ years

Dosage Form

Know‑how of all dosage forms

Job Responsibilities / Deliverables

• Prepare Regulatory Strategies for US market.
• Review and submit quality dossiers in the US market in line with regulatory strategy and expectations including Abbreviated New Drug Applications (ANDAs), New Drug Applications (NDAs) or 505(b)(2) applications.
• Plan and manage all pre‑approval submissions including pre‑IND, IND, pre‑NDA, pre‑ANDA, CGT requests and query responses.
• Manage various filings including submission of meeting requests, teleconference requests or controlled correspondence.
• Plan all the regulatory work to meet the filing schedule.
• Interact with the regulatory agencies and manage meetings with them as necessary.
• Coordinate with various stakeholders including Development Centers, Manufacturing Units, Quality Units, Supply Chain for needed documentation for timely and quality filings.
• Provide necessary regulatory clearances and assessments during the product development process including inactive ingredient clearances, biowaiver and size and shape clearances.
• Address any queries from the stakeholders regarding regulatory filings.
• Advise and guide the team on regulatory matters.
• Support organizational initiatives and manage the team to meet the deliverables.
• Ensure business growth and operational excellence within Regulatory Set up.

Qualifications & Pre‑Requisites

• Proficiency in Regulatory Affairs.
• Knowledge of Pharmaceutical Development and Manufacturing.
• Excellent leadership, analytical, communication, planning, interpersonal skills and act as a solution provider.
• Experience working with USFDA.
• Manage 100+ submissions annually including original filings and query responses.

Additional notes

Will need to work in different shifts.