Head of RA

Department: Regulatory Affairs

Location: Agomab US

Description

We are looking for an experienced Head of Regulatory Affairs to expand our team. Reporting to the Chief Medical Officer, the Head of Regulatory Affairs will be responsible for developing and driving the execution of global regulatory strategies, providing leadership and oversight for all interactions with regulators, and building a high functioning regulatory team.

This is a fantastic opportunity to join a small team, work on transformative science, and take part in building an exciting, science-driven global company.

Key Responsibilities

• Shape and lead regulatory strategies and submissions for the company's product portfolio to achieve corporate objectives;
• Provide regulatory guidance to project teams in all areas of regulatory affairs throughout the research and development process, approval, and post approval phases;
• Ensure that the Company's regulatory activities are compliant to the applicable regulatory requirements;
• Provide strategic and technical guidance and oversee the timely completion of regulatory projects and submission of documentation to regulatory agencies;
• Oversee all activities in support of INDs, NDAs, CTAs, BLAs, and other regulatory submissions like FT, BTD, ODD and PRIME;
• Provide regulatory review and final approval for all submissions and associated documentation;
• Develop and maintain current knowledge on price registration requirements and keep abreast of price registration procedures and changes, interprets regulations, give regulatory insight, advice and support to other departments;
• Serve as a primary liaison with health authorities and regulatory agencies; establish appropriate, proactive communication with agency officials to assure expedient and efficient review and approval of submissions; chair meetings between company and regulatory agencies and prepare internal teams for meetings with regulatory agencies at any phase of drug development;
• Participate in regulatory and CMC due diligence activities for licensing candidates in collaboration with business development group;
• Ability to travel as needed.
  
  

Skills, Knowledge And Expertise

• Minimum 10+ years of relevant global regulatory leadership experience in biotech and/or pharmaceutical industry;
• Expertise in the gastroenterology, hepatology, and respiratory therapeutic areas is a key asset
• BSc or higher academic degree, including MD and Pharm D.;
• Proven track record of success in supporting successful global Phase I-III clinical trials and progressing programs including INDs, early and late-stage development plans to completion with FDA and other major regulatory agencies;
• Experience with small molecules and biologics through approval is preferred;
• Experience building teams and establishing regulatory capabilities and functions;
• Demonstrated ability to develop and maintain excellent working relationships with US FDA and similar key international regulatory agencies including the planning/ implementation of agency meetings (Experience in US is required);
• Experience with CTD format and content for regulatory filings (e.g., INDs, CTAs, NDAs/BLAs);
• Excellent interpersonal communication and presentation skills to facilitate collaboration across functions and building successful relationships with internal and external stakeholders as well as external parties;
• Experience managing complex schedules and shifting priorities in a dynamic environment;
• Ability to dissect complex issues to quickly distill key issues for discussion with regulatory authorities and guide teams in the preparation of response to regulatory questions;
• Entrepreneurial thinker and attitude, highly creative and comfortable with hands on startup culture.
  
  

Benefits

• The opportunity to develop pioneering science in a young biotech company
• Challenging and innovative work environment as part of a driven team
• Flexibility and responsibility based in US with remote working options that can be tailored for you
• Competitive salary and benefits
• An agile and fast paced environment