Associate/ Senior Consultant - Regulatory Affairs & Policy Advocacy

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About the Organization

Biotechnology Industry Research Assistance Council (BIRAC) is a not-for-profit Section 8, Schedule B, Public Sector Enterprise, set up by Department of Biotechnology (DBT), Government of India as an Interface Agency to strengthen and empower the emerging Biotech enterprise to undertake strategic research and innovation, addressing nationally relevant product development needs.

BIRAC is a industry-academia interface and implements its mandate through a wide range of impact initiatives, be it providing access to risk capital through targeted funding, technology transfer, IP management and handholding schemes that help bring innovation excellence to the biotech firms and make them globally competitive. In its Eight years of existence, BIRAC has initiated several schemes, networks and platforms that help to bridge the existing gaps in the industry-academia Innovation research and facilitate novel, high quality affordable products development through cutting edge technologies. BIRAC has initiated partnerships with several national and global partners to collaborate and deliver the salient features of its mandate.

Job Description

The Regulatory Affairs & Policy Advocacy (RAPA) division within the Biotechnology Industry Research Assistance Council (BIRAC) facilitates innovators in navigating regulatory approval pathways and advocates for policies impacting startups, SMEs, and young entrepreneurs. This position under RAPA will be responsible for executing the activities detailed below.

Job Responsibilities

• Monitor real-time regulatory updates, connect with external stakeholders to identify potential opportunities and regulatory challenges impacting start-ups, entrepreneurs and innovators.
• Assess the current regulatory landscape and devise an integrated advocacy approach to minimize risks, driving innovation.
• Conceptualize, organize and manage regulatory workshops in areas of national importance.
• Arrange meetings and engage with national and international stakeholders including government, state, and industry associations along with key officials and diverse stakeholder groups from the public and private sectors.
• Oversee and manage the RAPA programs and fund disbursement process for regulatory offices.
• Contribute to public policy and advocacy efforts by coordinating and drafting responses to public consultations, position papers, and presentation for company representation at conferences and panels.
• Create and maintain databases, assist impact research and prepare white papers, knowledge documents, reports, position papers, and other sector-specific concept notes.
• Assist in any other activity of RAPA and work with the team for timely delivery of assigned tasks.

Education Qualification/Required Skills & Experience

Masters in any area of Life Sciences/ Biotechnology/ Agri / Plant Sciences/ Medical Research/ Regulatory Sciences/ Pharma/ Public Policy or any other related area.

 Desirable:

Ph.D in any of the above mentioned fields from a recognized institute

 Experience:

• Associate Consultant: Post Qualification, 3 years to 10 years with minimum 2 years of experience in national and international regulatory bodies, relevant industry, advocacy or consulting.
• Senior Consultant: Post Qualification, between 11 to 19 years, with minimum 05 years in national and international regulatory bodies, relevant industry, advocacy or consulting.

Experience in research paper, concept note preparation, data analysis using statistical tools is a plus.

Salary

The Consolidated fee for Associate Consultant shall be Rs.75,000/- and for Sr. Consultant shall be Rs.1,25,000/- per month.

For more information please check the Link

 

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