- Job Type: Full-Time
- Function: Regulatory Affairs
- Industry: Biotechnology
- Post Date: 02/15/2024
- Website: www.escientpharma.com
- Company Address: 10578 Science Center Drive, Suite 250, San Diego, CA 92121, US
About Escient PharmaceuticalsEscient is a clinical-stage pharmaceutical company focused on developing novel therapeutics to address a broad range of neurosensory-inflammatory diseases. Our pipeline includes two first-in-class small molecule antagonists targeting MRGPRX2 for the treatment of various mast cell-mediated disorders and MRGPRX4 for cholestatic pruritus.
$180,000 ‒ $235,000 Annually
Our team is driven by the desire to make a positive difference in the lives of patients. We are passionate about innovative science and strive to discover and develop novel medicines, to bring value to the healthcare ecosystem, and to address significant unmet medical needs. We foster a culture of innovation, collaboration, transparency, mutual respect, and integrity and an environment where employees feel fulfilled by the work they do and are recognized for the contributions they make.
Escient Pharmaceuticals is a San Diego based a clinical-stage company focused on developing novel therapeutics to address a broad range of neurosensory-inflammatory disorders. The company’s pipeline includes two first-in-class small molecule antagonists targeting MRGPRX2 for the treatment of various mast cell mediated disorders and MRGPRX4 for cholestatic pruritus. Escient is led by an experienced management and scientific team and funded by top-tier life science investors.
The Director, Regulatory Strategy provides global regulatory oversight and project leadership of assigned development products and reports to the Vice President Regulatory Affairs. The incumbent will be responsible for contributing to and implementing regulatory strategies and plans to expedite global product development, managing regulatory communications/interactions with health authorities, and ensuring compliance with applicable regional regulations. This position will interface closely with the cross functional Development team, as well as with external consultants and advisors, to ensure regulatory plans and strategies are well integrated and supportive of overall corporate objectives.
- Represent the Regulatory Affairs department on multidisciplinary product development teams
- Develop and implement global regulatory strategy to support expedited product development for one or more programs
- Contribute to content and lead preparation of global product development plans, target product profiles, orphan drug designation applications, pediatric study plans, as applicable.
- Research regulatory precedent and current/emerging trends related to product class and therapeutic area(s) to identify risks and opportunities for development/registration
- Manage global regulatory lifecycle of assigned investigational products, including maintaining project timelines, organizing submission content, and coordinating the internal/external authoring and review of components of original investigational drug applications, amendments, and safety and annual reports
- Interface with external Regulatory Operations group in the compilation and e-submission of regulatory documents
- Serve as primary liaison for communication with regulatory health authority on assigned programs
- Prepare team for and lead the conduct of milestone development meetings with regulatory health authority
- Review and communicate current and emerging regulatory requirements for quality, preclinical, and clinical programs to ensure compliance of all development activities with applicable US and international regulations and guidelines
- Participate in the development and review of standard operating procedures (SOPs); ensure SOPs are in compliance with current regulatory requirements
- Assist in the archival and maintenance of regulatory application submissions and correspondence.
- Monitor company progress toward fulfillment of regulatory commitments
- Bachelor’s degree in a life sciences discipline; advanced degree preferred; Regulatory Affairs Certification a plus
- Minimum 7 years pharmaceutical Regulatory Affairs experience with focus in development of drugs/biologics
- Direct experience in preparation, submission and lifecycle management of global investigational/marketing applications in eCTD format, including as primary Regulatory author
- Experience negotiating and directly interfacing with US and international regulatory authorities
- Product development in therapeutic areas of dermatology, immunology or inflammation a plus
- In depth knowledge of GXP/ICH guidelines and global regulations and systems
- Ability to interpret and apply complex and evolving regulatory guidance
- Strong written and verbal communication, analytical, organizational and interpersonal skills
- Excellent strategic planning and cross-functional project management skills
- Ability to work in a dynamic environment with a high degree of flexibility
Salary Range: $180,000 - $235,000
If you thrive in a fast-paced, entrepreneurial environment and are in search of a dynamic, multi-disciplinary team focused on discovering and developing therapies that will positively change the course of the health and well-being of underserved patients, we encourage you to apply. Escient Pharmaceuticals offers a positive and exciting work environment with competitive pay structures and benefits. Escient is an equal opportunity employer.