DGM-Regulatory Biologics

Job Description

Position : Head Biologicals – Regulatory CMC

Grade : G8

Job Location : Gurgaon (preferable)/Baroda/Mumbai

Education : M.Pharm/M.Tech/MS/ PhD (Pharmaceutics/Biotechnology)

Department : Global Regulatory Affairs – Innovative Medicines

Job Responsibilities

• Lead the global regulatory team in the CMC strategy development for established Medicines (Biologics) being developed for US, EU, Canada, Australia, Brazil and RoW markets.
• Coordinate with peers in cross functional team for data driven decision making process for CMC regulatory strategies for established products (Biologics) to be launched for US and other advanced markets like EU, Canada Australia, Brazil, etc.,
• Drive the development projects in collaboration with leads from CFT and project management team towards the regulatory milestones across various geographies
• Mentor the CMC regulatory team in submission management (IND/IMPD, BLA, MAA) and life cycle management of the projects under scope in various markets
• Provide regulatory leadership as needed in product in-license/due diligence review, product divestment and product withdrawal.
• Represent the regulatory dept in the agency correspondence meetings or scientific advice meetings and guiding the team to prepare for the regulatory meeting packages
• Support new technology development within our Company.
• Demonstrate an understanding of regulatory affairs and applies this understanding to the benefit of the company to ensure the approval and continued market supply of our Branded products worldwide.
• Conduct all activities with an unwavering focus on compliance.
• Manage the team and be accountable for the deliverables.
  
  

• Should have handled the successful regulatory submissions for novel biologics / biosimilars for developed markets and Row markets
• Should be able to evaluate the technical information required to build zero defect dossiers of biological products for IND, NDA, BLA and MAA for various markets
• Hands of expertise of preparation & review of dossiers, response to queries, communication with agencies for developed markets like US/EU
• Excellent communication skill in orating and narrating the regulatory requirements and scientific rationale to negotiate with internal and external stakeholders
• Demonstrate sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.
  
  

• Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders.
• Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
• Demonstrated effective leadership, communication, interpersonal and negotiating skills.
  
  

• M-Pharm in pharmaceutical sciences /PhD
  
  

• 15-20 years of hands-on experience in regulatory affairs
• This role needs a seasoned professional who is aware of the regulatory activities for NDAs, can work in R & D CFT and who has the management capability of leading a group of team members
• Preferable to have hands on experience in development, manufacture, testing and release of the biotechnology products.
• The candidate must be proficient in English; additional language skills are a plus.
• Good inter-personnel skills with ability to direct multi-departmental functions.