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Regulatory Affairs Associate
Job Opportunity at
Spark Therapeutics, Inc
Posted on Feb 23
The Regulatory Affairs Associate, under general guidance, prepares, reviews and submits high quality, regulatory submissions to the FDA, EMA and other health authorities within company timelines and in accordance with regulatory guidelines and applicable federal laws. Submissions include amendments, supplements, annual reports, DSURs and additional documents as needed. Compiles and reviews amendments, supplements, annual reports, etc., for FDA and other health authority submissions. Interacts effectively with cross functional team members in order to coordinate documentation required for submissions, ensuring that timelines are met.
Coordinate all aspects of regulatory submissions relevant to assigned projects and programs, in accordance with submission and regulatory requirements.
Interact with functional groups across the organization in the development of relevant data to complete regulatory submissions.
Define contributions for submissions, communicate to functional contributors and track delivery according to agreed timelines.
Coordinate activities to maintain regulatory filings including planning and preparing annual reports, DSURs for INDs, CTA, etc.
Support the development of regulatory processes to manage pre-approval compliance activities.
Support the development of regulatory processes for submission planning and management.
Other projects and duties may be required.
Excellent interpersonal communication and organizational skills
Possesses strong critical and logical thinking
Demonstrated strong writing and communication skills
Strong attention to detail
Demonstrated ability to work both independently and in a team environment
Demonstrated ability to multi-task, manage competing priorities (i.e. working on two or more projects with overlapping timelines)
Highly flexible, adaptable, and experienced in a fast-paced environment
Demonstrates excellent organization skills and the ability to multi-task; detail oriented.
Demonstrates the ability to establish and maintain good working relationships at all levels of the company and with external contacts
Demonstrates excellent verbal and written communication skills.
BS in a scientific discipline or equivalent education
Minimum 2-5 years experience in a Regulatory Affairs pharmaceutical or related environment with biologics experience preferred.
Working knowledge of all FDA requirements pertaining to submission of regulatory documents
Demonstrated ability to coordinate submissions independently in a time intensive situation
Experience in hemophilia preferred
WHO WE ARE:
Transforming Patient’s Lives. Spark Therapeutics is a pioneering gene therapy leader transforming the lives of patients suffering from debilitating genetic diseases by developing one-time, life-altering treatments. We are embarking on our goal to deliver the first approved gene therapy product in the US for genetic blinding conditions and have a product pipeline addressing other unmet rare genetic diseases. We have an entrepreneurial culture and are looking for talented and passionate professionals who are committed and motivated to making a difference in the lives of our patients. If you share our passion for excellence and are looking for a dynamic work environment that fosters creativity, scientific innovation and team collaboration, you may be a great fit for our team.
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