The Sr. Manager/ Manager of Regulatory Affairs is responsible for the implementation of regulatory strategies and direction for assigned Quark Project Teams under the leadership of the Vice President of Regulatory Affairs and Quality Assurance. S/he must have a comprehensive understanding of FDA/EU/ICH requirements, principles, concepts, industry practices, and standards. In this hands-on role, s/he coordinates, reviews and edits the preparation of regulatory documents. Duties include preparing, reviewing, and editing of clinical trial applications (CTAs), investigational new drug applications (INDs), and key documents associated with these applications as appropriate and in compliance with national and international regulations and laws (e.g. Annual updates, Investigator’s Brochure, labeling). The position provides the opportunity to provide input into a wide variety of drug development aspects associated with Regulatory Affairs.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
- Represents Regulatory Affairs in project teams to develop product registration strategies and development plans aimed at achieving product application approvals.
- Provide expert guidance to project teams on regulatory mechanisms to optimize product development.
- Manage, review, plan, and prepare complex regulatory documents for global submissions.
- Ensure that documents and regulatory submissions for domestic and international product development and registration are complete, organized, and compliant with applicable regulations.
- Build and maintain relationships with outside service providers to prepare and submit dossiers globally.
- Analyze changing regulatory requirements, evaluate risk, and establish contingency plans to assure timely submissions.
- Develop and maintain effective working relationships with multiple international regulatory agencies, as well as represent Quark at meetings with various regulatory
- Provide regulatory guidance to functional areas to ensure understanding and compliance with appropriate regulations and guidelines.
- May supervise Associate level employees.
- Regularly interact with senior management.
- Bachelor’s Degree in physical/life sciences
- Six or more years of Regulatory Affairs experience in the pharmaceutical or biotech industries required.
- Knowledge of drug development, product licensure, and regulatory
- Knowledgeable in ICH/cGMP/GLP/GCP, and regulatory guidelines as applied to the entire Development lifecycle of biotech and pharmaceutical companies.
- Successful experience in the preparation of INDs and CTAs.
- Knowledge of eCTD submission structure and process a plus.
- Experience with US and international regulatory practices and procedures.
- Flexibility and willingness to multitask and change priorities in a dynamic environment.
- Strong organizational, planning, problem solving, and decision-making skills.
- Excellent written and verbal communication skills and collaborative working style.
- Desirable to have experience in renal, hepatic transplant and/or ocular indications.
- Ability to work independently and keep management updated.
Quark Pharmaceuticals, Inc. is a late clinical-stage pharmaceutical company, a leader in the discovery and development of novel RNAi-based therapeutics for unmet medical needs. Two products, which were granted Orphan designation, QPI -1002 and QP -1007 are in global phase III pivotal clinical studies for Delayed Graft Function (DGF) and Non Arteritic Ischemic Optic Neuropathy (NAION) respectively
Quark is vertically integrated from gene discovery to novel therapeutics. Assuring its broad pipeline of clinical and preclinical product candidates is the internally developed technology, which includes Quark’s RNAi platform technology its delivery to a host of organs. Quark products and technology have freedom to operate in the nucleic acid intellectual property space.
The company has a string of enabling alliances on products and technologies. QPI -1002 is exclusively option licensed to Novartis worldwide; PF-655 is licensed to Pfizer worldwide on exclusive basis. QPI -1007 is licensed to RiboQuark, Quark’s Chinese joint venture company with Suzhou Ribo Life Science Co., Ltd (Ribo) for China and certain additional countries and to Biocon Limited for India and additional countries. (Read more about the company’s collaborations}
Quark is a privately held company incorporated in California. The headquarters of Quark is located at 6501 Dumbarton Circle, Fremont, CA 94555, USA, and the R&D facilities at 2990 Wilderness Place, in Boulder Colorado 80301 and at QBI Enterprises, Ltd. in Nes Ziona, Israel. QBI Enterprises, Ltd. is a wholly owned subsidiary of Quark Pharmaceuticals, Inc.
To apply, please send CV to HR_US@quarkpharma.com