Prelude is seeking a highly skilled and motivated individual with the experience and technical expertise to lead our regulatory operations and publishing activities in Wilmington, DE location. Prelude is an early stage biotechnology company founded by proven scientists in cancer drug development. Our research is focused on developing highly selective and differentiated small molecule therapeutic agents targeting novel pathways for the treatment of cancer and rare diseases. Prelude offers a vibrant and collegial work environment and excellent career growth opportunities. Prelude is ideally located within 25 minutes from the Philadelphia International Airport at the Delaware Innovation Space, an emerging research campus in the DuPont Experimental Station.
The Associate Director Regulatory Operations will be the key player in management of all regulatory submissions for Prelude. The Associate Director, Regulatory Operations is responsible for compiling submissions into the eCTD format and performing document and submission level QC for compliance with regional regulatory guidelines, as well as the planning, coordination, and support of Prelude's regulatory submissions. The successful candidate will also be expected to take a leadership role in preparing global electronic regulatory submissions including INDs, annual reports, amendments and NDAs in line with project plans. The Associate Director, Regulatory Operations will ensure appropriate communications and processes between regulatory staff, project teams and vendors to ensure successful on-time, complete submissions. The successful candidate will drive, promote and embed a collaborative culture, solution and continuous improvement mindset that will focus on delivering efficiencies and planned business benefits to support Prelude in moving through development stage to marketed products.
Format, bookmark, link and publish regulatory submissions, ensuring high quality, compliant and valid submissions to global health authorities within required timeframes.
Coordinate logistical details associated with generating electronic regulatory submissions, including publishing activities, timeline planning, set up of document management, authoring and publishing tools.
Contribute to the preparation of scientific and regulatory documents.
Compile submissions into the eCTD format and perform document and submission level QC for compliance with regional/ICH guidelines and internal procedures/instructions.
Support regulatory activities and coordinate filings (e.g. IND, amendments, NDA) as appropriate.
Stay current with new electronic submission and regulatory documentation practices issued from global health authorities.
Contribute to new and updated processes and standards.
Participate in validation testing of new and upgraded software.
Ensure health authority correspondence and dispatched submissions are filed and archived appropriately in a timely manner.
Collaborate with Regulatory Affairs group in the management of submission components and tracking of deliverables.
Interpret local and global electronic submission regulations and prepare interpretative analyses of key regulatory guidance documents related to submissions.
Bachelor’s Degree in Pharmaceutical Science or science related field with a minimum of 8 years Regulatory Affairs Operations experience
Experience and knowledge of IND/NDA/eCTD and other electronic requirements and guidelines
Current knowledge of FDA, EMA and ICH regulations/guidance and requirements, with a demonstrated ability to apply these requirements to prepare and QC regulatory submissions.
Highly Proficient in MS-Office, Adobe Acrobat applications, electronic document systems (e.g. Sharepoint, Veeva)
Advance knowledge of document authoring templates (eg. StartingPoint), document management and regulatory publishing (eg. GlobalSubmit or similar), eCTD validation and viewing tools and XML are required
Ability to anticipate future needs and coordinate activities with other team members
Experience implementing organizational processes, identifying needs for additional resources, designing and developing company policies, providing training as needed, and ensuring adherence to company policies and quality requirements, as appropriate
Effective oral, written communication, interpersonal and organizational skills
Prelude Therapeutics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, c
Internal Number: 201920
About Prelude Therapeutics Incorporated
Prelude is a privately-held, clinical-stage biopharmaceutical company designing and developing a pipeline of novel, orally bioavailable, small molecule therapies that target key drivers of cancer cell growth, survival and resistance.