Principal Associate, Regulatory Technology and Ops
Overview
The Principal Associate, Regulatory Operations will be responsible for administration, maintenance, and business support of Alnylam’s Regulatory Information Management (RIM) environment(s) and ensuring RIM data in the system is current, accurate, reliable, and fit for purpose at any given point in time.
Responsibilities
* Collaborates with data owners to ensure that data is entered into the company’s RIM system(s) in compliance with company / industry / agency standard(s).
* Acts as a quality gate to ensure compliance with the company’s Regulatory Information data standard.
* Prepares and ensures the submission of data and supporting documentation to external agency databases (i.e. XEVMPD, IDMP) in compliance with agency requirements and standards. Actively contributes to responses to agency queries raised following any submission.
* Builds strong working relationships with information providers / verifiers (primarily) within Regulatory Affairs to encourage and support accurate, timely and reliable entry of Regulatory information into the company’s RIM system(s).
* Supports the Regulatory Affairs team in the analysis of Regulatory Information to identify trends that can be presented in business intelligence reports to management.
* Coordinate with Regulatory Affairs/Operations colleagues in the receipt and archival of regulatory files transmitted from global partners and affiliates.
* Provide end user support and additional guidance/training for the company’s eDMS, resolving IT tickets to support end users and creating accounts for any new users.
* Maintain familiarity with current global regulatory submission standards, software validation concepts, and publishing best practices.
* May participate in the development and implementation of regulatory operational systems and software (e.g. document management systems, databases, etc.).
* Perform administrative functions as directed by Management to support projects and to ensure the smooth operation of the department.
* Assist in publishing efforts during peak workloads or as required.
Requirements
* Bachelor’s degree or relevant equivalent experience.
* Experience with Regulatory Information Management is required.
* Knowledge of XEVMPD and IDMP requirements.
* Knowledge of CTD format and submission requirements in applicable region(s).
* Exposure to drug development, including knowledge of the contents of regulatory submissions and product life-cycle and how other functions contribute to them.
* Advanced experience in MS Word, MS Excel, SharePoint and Adobe Acrobat.
* Experience with electronic document management software, eCTD publishing software, principles of information systems, and related technology is required.
* Confidence and ability to learn new software tools is essential.
* Must be able and willing to work in a high-visibility, fast-paced environment. Must be flexible, detail-oriented, and possess good analytical and problem-solving skills.
About Alnylam
Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by interfering with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.
Our culture
Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we’ve been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as one of Science Magazine’s Top Biopharma Employers, one of America’s Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK – among others.
Equal opportunity
At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients.
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Information Technology
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