Associate/Senior Associate, Regulatory Affairs« Back
Job Title: Associate/Senior Associate, Regulatory Affairs
Location: Waltham, Massachusetts
Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients. We have used our proprietary drug discovery platform to develop a diverse pipeline of drug candidates designed to improve outcomes for patients with cancer by enhancing the quality, rate and/or durability of their responses to treatment. We currently retain global development and commercialization rights to our drug candidates, including three programs in clinical development. Deciphera (NASDAQ: DCPH) is a publicly traded company headquartered just outside Boston in Waltham, Massachusetts. Our state-of-the-art research facility is located near the University of Kansas School of Pharmacy in Lawrence, Kansas.
We offer an outstanding culture and opportunity for personal and professional growth based on these key principles:
• providing a collaborative, energized and fun work environment where people are empowered and supported in the achievement of their career goals
• a diverse and multi-disciplinary workforce
• dedicated and talented people who are passionate about achieving excellence in all they do
• a work environment that allows you to balance your priorities
• above all else, a commitment to the patients we serve
We are seeking an Associate/Senior Associate, Regulatory Affairs to assist in the development and implementation of regulatory strategy for multiple projects and ensure execution of related regulatory submissions. Working in a team environment, the Associate/Senior Associate will be responsible for planning and coordinating multiple aspects of regulatory submissions necessary to support clinical trials and product registration.
This position will report to the Senior Manager, Regulatory Affairs and be located in the Waltham, MA office.
• Under supervision, the (Sr) Regulatory Affairs Associate will work with cross functional colleagues in providing support for regulatory filings, creation of internal regulatory documents, and assist with ensuring internal compliance with GXP regulations and policies
• Define contributions for submissions, communicate to functional contributors and track delivery according to agreed timelines
• Identifiy and compile all materials required in U.S. and/or ex-US regulatory submissions, this includes annual reports, DSURs for INDs, CTAs, IND/NDA/MAA applications, etc. as necessary
• Assist in coordination and compilation of responses to inquiries from global regulatory authorities
• Review regulatory submissions to ensure that the elements, quality, accuracy, and format are consistent and comply with applicable laws, regulations and corporate standards
• Develop and maintain current regulatory knowledge and keep abreast of regulatory procedures and changes
• Proficient in MS Office Applications including MS Outlook, MS Word, MS Excel, MS Powerpoint.
• The Regulatory Affairs Associate is ideal for candidates with a BA/BS degree or higher with at least 2 years of professional experience in clinical research, regulatory affairs, or a related field regulated by the FDA. Title will be commensurate with education and experience.
• Proficiency in regulatory (FDA, ICH, GCP, and GMP) guidelines
• Keen planning skills but must also possess the skills to work in a high-paced work environment and be able to effectively manage multiple tasks
• Should be able to present their ideas clearly and concisely and have excellent written and oral communication skills
• Highly detail-oriented and organized
• Ability to positively interact with individuals from many departments
• Must have a working knowledge of Microsoft Office programs and Electronic Document Management Systems
Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for either health care and/or dependent care.