Senior General Manager Full Time

Company Overview:

Rubicon Research Limited is a fast-growing pharmaceutical formulation company delivering value to our customers and investors by developing, manufacturing, and marketing branded specialty and generic prescription pharmaceutical products in regulated markets.

Our product portfolio comprises over 250 SKUs across more than 70 product families. We have an established marketing, sales, and distribution platform in the US through our subsidiaries AdvaGen Pharma which markets non-branded prescription products, and Validus Pharmaceuticals which markets branded prescription products and promotes them to healthcare practitioners in the US.

We have two US FDA-inspected R&D facilities – one each in India and Canada, and two manufacturing facilities in Maharashtra, India with multiple accreditations from multiple regulatory agencies such as US FDA, Food and Drugs Administration, Maharashtra (WHO-GMP accreditation) and Health Canada. Our facilities are equipped with various drug development and manufacturing capabilities across dosage forms.

Headquartered in Thane, India we have a sales and marketing office in New Jersey, USA.

For additional information visit www.rubicon.co.in

Position Overview:

This position will lead and be accountable for the pre-approval regulatory efforts in the US

market.

Key Responsibilities:

• 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 needful 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.