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.