POSITION SUMMARY:
Based in Germantown, Maryland Precigen is seeking a highly motivated and experienced Senior Manager/Manager, Regulatory Affairs(level based on candidate experience). This role is responsible for knowledge and application of global regulations governing pharmaceutical drug development. Working with the Vice President, Regulatory Affairs this position will participate in the development and implementation of regulatory strategies for specific drug development programs (pre and post market approval). This individual will also be responsible for generating and/or review of technical areas for IND/BLA preparation, labeling, operations, and/or regulatory intelligence. The Senior Manager/Manager will interact with all aspects of Precigen's quality, CMC, preclinical, and clinical drug development programs, policies, and procedures ensuring compliance is maintained with all regulatory commitments/requirements.
DUTIES AND RESPONSIBILITIES:
Responsible for management of day to day Regulatory Affairs activities for investigational and commercial products, serving as liaison between company and FDA and other global Regulatory authorities for assigned programs Support regulatory strategies for assigned programs, in order to support Precigen's development and marketing objectives. This will be achieved through analysis of guidance's and assessment of other drugs, and in collaboration with Precigen's senior regulatory management. Participation in project team and sub team discussions regarding preclinical, clinical and CMC aspects of drug development, providing regulatory guidance, communicating regulatory goals and timelines, and helping to ensure compliance to the requirements from U.S. and foreign regulatory agencies. Help to identify and assess regulatory risks, understanding global imperatives including market-related drivers; plans and implements appropriate mitigation strategies. Develop effective professional relationships and promotes a positive company image with FDA and global regulatory authorities. Coordinates regulatory workflow, provides regulatory support and tracks regulatory timelines pertaining to area of responsibility. Management of the planning, preparation and submission process for IND and licensing applications. Specifically assisting with the writing and/or editing of scientific sections of regulatory documentation needed for Module 2 Summary sections. Continually monitor newly published FDA guidelines and international guidance documents in the context of new and ongoing development programs. Provide training on applicable requirements for scientific staff as required.
EDUCATION AND EXPERIENCE:
Bachelor's degree preferably in life science or a related field, advanced degree strongly preferred. Five (5) years of direct regulatory affairs experience in biotech or pharmaceutical environment. Comprehensive knowledge of regional health authority regulations and advanced knowledge of global regulations/guidelines governing development of pharmaceuticals, biologics and medical devices. Experience in compilation of Regulatory submissions using eCTD (electronic common technical document) preferred.
DESIRED KEY COMPETENCIES:
Exceptional leadership, planning, organization, and execution skills. Organized self-starter. Ability to understand and execute on the company's mission and values. Strong analytical and decision-making skills with attention to detail and quality. Exhibits impeccable confidentiality on sensitive, supporting tasks. Ability to anticipate and solve problems while analyzing complex issues and environments. Ability to communicate and work effectively with all levels of employees in various communication mediums. Possess a high degree of personal responsibility. Ability to adapt and succeed in a milestone-driven, rapidly changing product development and commercialization environment. Computer literate with proficiency of Microsoft Office package including Word, Outlook, Excel, and Adobe PDF.Strong organizational and analytical skills with attention to detail.
WORK ENVIRONMENT: Administrative office/cubical; some laboratory and manufacturing area access
Frequent: Speaking; hearing; sitting; use of hands/fingers; handling or feeling objects, tools or controls; close vision; color vision; peripheral vision; ability to adjust focus. Occasional: Standing; walking indoors; reaching with hands and arms; stooping; kneeling; crouching; lifting and/ or move up to 10lbs. General: Moderate noise level, similar to typical office environment with computers, printers and light traffic. Some business travel is required.
