- Job Type: Full-Time
- Function: Regulatory Affairs
- Industry: Biotechnology
- Post Date: 05/22/2023
- Website: www.escientpharma.com
- Company Address: 10578 Science Center Drive, Suite 250, San Diego, CA, 92121
- Salary Range: $270,000 - $325,000
About Escient PharmaceuticalsEscient Pharmaceuticals is a provider of bio-technical research and development services intended to focus in advancement of first-in-class G Protein-Coupled Receptor targeted drugs. The company's services focuses on offering therapies for neuro-immuno-inflammatory and autoreactive diseases, enabling its clients to receive drugs required fortreatment of serious, unserved medical needs across a broad range of therapeutic indications.
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.
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 is seeking a dynamic, creative and highly motivated individual for the position of Vice President, Regulatory Affairs. The ideal candidate is forward thinking and creative with high ethical standards, a team player with strong leadership skills who is able to work in a fast-paced environment with drug development professionals, and able to respond to changing priorities in a thoughtful, creative manner.
PRIMARY RESPONSIBILITIES include the following:
- Develop and implement global regulatory plans for the company’s product candidates
- Act as primary liaison and coordinate meetings with FDA, EMA and other health authorities as needed, representing the company with those agencies
- Responsible for regulatory operations, regulatory CMC and regulatory strategy
- Oversee planning and conduct of interactions with, and submissions to, global regulatory authorities (INDs, NDA/MAAs, DSURs, PIND/EOP2 meetings, etc.)
- Review clinical protocols and study reports, manufacturing process documentation, investigator brochures, safety reports, and other relevant documents
- Establish and maintain relationships with senior regulatory consultants and advisors; manages regulatory vendors and budget
- Actively track developments in global regulatory guidance and policy, and maintain strong relationships with industry peers to identify emerging trends, risks and opportunities
- Ensure compliance with applicable regulatory reporting requirements, laws and regulations
- Support business development and financing initiatives as needed (e.g., participate in due diligence efforts, interact with potential investors and partners).
- Serve on Company’s senior leadership team, interact closely with the CEO and other officers, participate in board of director meetings as appropriate
EDUCATION AND QUALIFICATIONS
- Science degree (PhD, PharmD, MD, MSc) with extensive experience in regulatory leadership
- Minimum of 10 years of experience in Regulatory Affairs in the biopharmaceutical industry
- Proven track record of success in advancing product candidates through various stages of early and late stage development, including regulatory interactions and submissions
- In-depth knowledge of global regulatory requirements
- Prior experience in dermatology or immunology and inflammation preferred
- Excellent strategic planning, team building and leadership skills
- Strong interpersonal skills
- Strong written and verbal communication skills
- Ability to thrive in a fast-pace, hand-on research and development environment
This is a hybrid remote position, and candidates must be able to work from the San Diego corporate office up to two weeks per month. Travel will be required to the extent necessary for regulatory interactions and other business needs (anticipated 5 – 10%).
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee will regularly be required to use his/her hands and fingers to operate a computer keyboard, mouse, and telephone keypad or to write, as well as talk and hear. The employee will regularly be required to sit, stand, walk, talk and hear; use hands to handle or feel; see computer screens and read printouts; and reach with arms and hands. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and ability to focus.
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.
Escient Pharmaceuticals, Inc.’s Human Resources team manages its own recruitment and employment process. To protect the interest of all parties involved, Escient will only accept resumes from a recruiter if an executed search agreement is in place at the start of the recruitment effort for a particular open position. Unsolicited resumes sent to Escient from recruiters do not constitute or create any type of relationship between the recruiter and Escient, and Escient shall not pay any fees should we hire any individual from those resumes. Recruiters are requested not to contact or present candidates directly to Escient’s hiring manager or employees.