Postdoctoral Research Fellow, Alnylam, Regulatory Affairs
Location: BOSTON, Massachusetts
Internal Number: R109084
The Northeastern University Pharmaceutical Industry Fellowship program will not accept PPS candidate interview requests.
Candidates will need to apply in advance through the Northeastern University career portal.
Click here to visit our webpage for more information on how to apply.
Position: Northeastern University Postdoctoral Research Fellow, Alnylam, Regulatory Affairs
The Northeastern University Fellowship Program provides a dynamic academic environment offering fellows the opportunity for a wide breadth of experiences:
Develop teaching skills through participation in our Teaching and Learning Seminar series
Facilitate small and large group didactic education in partnership with a faculty mentor
Utilize a layered learning model in experiential education by co-precepting students on pharmacy practice experiences including Northeastern’s unique co-op program
Create, present, and publish scholarly research through collaborative industry and university relationships
Engage with faculty who participate in various interdisciplinary graduate programs including biotechnology, nanomedicine, immunology, health informatics, and drug discovery
Network with area residents and other Northeastern fellows via professional development programs, teaching seminars, and participation on fellowship committees
Alnylam is delivering on a bold vision to turn scientific possibility into reality, with a robust RNA interference (RNAi) therapeutics platform. As the pioneer in RNAi and the leading RNAi therapeutics company, we have always been uncompromisingly dedicated to translating the breakthrough science into transformational medicines to help as many people as possible. Long focused on rare and genetic diseases, our scientific advances are now allowing us to bring the power of RNAi therapeutics to more prevalent diseases and as a result, we are beginning to recognize the full potential of this new class of medicines.
Alnylam is committed to its journey to become a top 5 independent, global biopharma company. We are already admired and recognized for our dedication to patients, company culture that empowers people to do their best work, track record of scientific innovation, social responsibility, and commercial excellence.
Founded in 2002, and headquartered in Cambridge, Mass., Alnylam has over 1,650 employees at work across the globe. We are seeking smart, passionate, “change the world” kind of people who are ready to say, “challenge accepted” to our mission. Thanks to the commitment of every employee globally, Alnylam is proud to have been recognized as one of Fast Company’s 2021 Best Workplaces for Innovators, a Science Magazine Top Employer three years in a row (2019-2021), a Boston Globe Top Places to Work seven years in a row (2015-2021), a Great Place to Work in Asia, Japan, Brazil, the U.K., Germany, Spain, Netherlands, Italy, France and Switzerland, Seramount’s 100 Best Companies (formerly Working Mother 100 Best Companies) and Best Companies for Dads, Bloomberg’s Gender Equality Index two years in a row (2021-2022), among others. At Alnylam, we are committed to fostering a diverse, equitable and inclusive work environment, culture, and workforce, and we support several Employee Resource Networks.
In 2015, Alnylam Pharmaceuticals partnered with Northeastern University to offer a unique fellowship opportunity in the heart of Boston. The program set out to equip postdoctoral PharmDs with the skills necessary to develop the advanced medicines of the future, like RNAi. The goal was and remains the same: to cultivate the future leaders of biotechnology and allow fellows to pioneer new therapies for patients. Alnylam fellows are grounded in their core expertise area but utilize the fellowship’s flexibility to branch out and discover other opportunities throughout the organization with personalized rotational experiences. Part of the backbone of the fellowship program is the Northeastern University teaching opportunities which allow fellows to share their knowledge in an educational setting.
Regulatory Affairs at Alnylam is a global group with diverse scientific, technical, and clinical expertise. The team is responsible for creating and implementing global innovative strategies to support expedited drug development and approval of Alnylam’s products. Effective support and management continue throughout Alnylam’s product life-cycle. Assuming increasing responsibility over the two years, the Global Regulatory Strategy fellow will gain hands-on experiences by participating in unique opportunities both within the rare and prevalent diseases.
Responsibilities - Regulatory Affairs:
Support, prepare, and submit a wide range of regulatory filings such as investigational new drug applications, new drug applications, international marketing authorization applications, and clinical trial applications
Collaborate with Clinical, Commercial, and Medical teams in US and EU to achieve regulatory milestones and support new product launches
Conduct guidance and precedent research to support regulatory strategy and regulatory chemistry, manufacturing, & controls (CMC)
Actively participate in creation and implementation of product prescribing information
Support the development and maintenance of regional labeling and advertising & promotion across programs
The fellows will primarily work at Alnylam’s office in Cambridge, Massachusetts. Northeastern University responsibilities will be carried out on the Northeastern Boston campus.
Doctor of Pharmacy degree from an ACPE accredited institution, eligible for licensure as a pharmacist in the State of Massachusetts.
Excellent oral and written communication, time management, and leadership skills, ability to work independently and take initiative on a variety of projects at the industry site and Northeastern.
Additional Information: Applicants should submit the following APPLICATION MATERIALS by the priority deadline of October 31st, 2022:
Curriculum vitae (CV), uploaded
Unofficial PharmD transcripts, uploaded
Cover letter, uploaded
Three formal letters of recommendation (LORs) sent directly from the letter writer to PharmDFellowships@northeastern.edu by November 28th, 2022. LOR writers should include the candidate’s name and fellowship program(s) in the subject line (e.g. Smith, John – Alnylam, GSK).
Address cover letter and three LORs to:
J. Andrew Orr-Skirvin, PharmD, BCOP
Clinical Professor, School of Pharmacy
Chair, Department of Pharmacy & Health System Sciences
Director of Pharmaceutical Industry Fellowship Program
360 Huntington Ave, 140TF R218
Boston, MA 02115
Northeastern University is an equal opportunity employer, seeking to recruit and support a broadly diverse community of faculty and staff. Northeastern values and celebrates diversity in all its forms and strives to foster an inclusive culture built on respect that affirms inter-group relations and builds cohesion.
All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, religion, color, national origin, age, sex, sexual orientation, disability status, or any other characteristic protected by applicable law.
The NORTHEASTERN FELLOWSHIP PROGRAM provides fellows with dynamic biopharmaceutical industry experiences with the benefits of an academic environment. Over two-years, fellows work at one of the partner companies located in the greater Boston and Cambridge, MA areas and at Northeastern University’s School of Pharmacy.
LEARN MORE at NUfellowship.com.