Find & Apply For Regulatory Affairs Manager Jobs in Boston, Massachusetts

Intellia Therapeutics - Global Regulatory Affairs Postdoctoral Research Fellow Northeastern University - 4.2 Boston, MA Job Details Full-time $60,315.00 - $85,192.50 a year 8 hours ago Benefits Health insurance Dental insurance Tuition reimbursement Paid time off Vision insurance Life insurance Qualifications Doctor of Pharmacy Project leadership Full Job Description About the Opportunity About the Opportunity Northeastern University Pharmaceutical Industry Fellowships Program is a two-year experiential program designed to advance lifelong learning and the education and training of Pharm.

D. graduates. A key element of the program's success is preparing Fellows to meet evolving workforce needs across various sectors of the pharmaceutical industry. Fellows have the opportunity to work closely with our innovative biopharmaceutical industry partners, while engaging with Northeastern University faculty in professional and career development, teaching, service, and scholarly activities. In partnership with Northeastern University, Intellia Therapeutics is offering a two-year Regulatory Affairs PharmD fellowship based in Cambridge, MA. About Intellia Intellia Therapeutics is a Cambridge-based biotechnology company focused on developing clustered regularly interspaced short palindromic repeats (CRISPR)-based gene editing therapies to transform lives of people with severe diseases. In fact, Intellia's co-founder Jennifer Doudna along with Emmanuelle Charpentier were awarded the 2020 Nobel Prize in Chemistry for their pioneering work in CRISPR. At Intellia, we are humbled to contribute to what we believe to be medical history. As a leader in this field, our responsibility and commitment to patients is critical in our pursuit of developing novel, potentially curative therapeutics utilizing CRISPR-based technologies. More specifically, we are employing a modular gene editing platform to create diverse in vivo and ex vivo therapeutics, spanning a range of disease indications. Guided by this full-spectrum approach, we are committed to making CRISPR-based medicines a reality for people living with genetic diseases and to creating novel engineered cell therapies for various cancers and autoimmune diseases.

Intellia Regulatory Affairs Fellowship Program Overview:

Northeastern University Pharmaceutical Industry Fellowships Program is a 2-year experiential program designed to advance lifelong learning and the education and training of PharmD graduates. A key element of the program's success is preparing Fellows to meet evolving workforce needs across various sectors of the pharmaceutical industry. Fellows have the opportunity to work closely with our innovative biopharmaceutical industry partners, while engaging with Northeastern University faculty in professional and career development, teaching, service, and scholarly activities. In partnership with Northeastern University, Intellia Therapeutics is offering a 2-year Regulatory Strategy and Advertising/Promotion/Labeling (APL) fellowship, based in Cambridge, MA. What Sets the Intellia Fellowship Apart? The Fellow will collaborate within Global Regulatory Affairs at Intellia, gaining hands-on experience, contributing to the team, and developing valuable leadership skills. This Regulatory Fellowship is unique in that it offers the opportunity for a blended experience during the first year, encompassing both Strategy and Advertising, Promotion & Labeling. In the second year, the Fellow will have the opportunity to select between the two disciplines, honing skills they developed during the first year and taking a deeper dive into specialized regulatory activities to provide the Fellow with a strong understanding of the drug development and approval landscape, and global regulatory frameworks. Responsibilities DEVELOP in-depth knowledge of Intellia's CRISPR gene editing technology—as well as the pathophysiology, epidemiology, and treatment landscape of relevant therapeutic areas—to support strategic conversations and APL reviews

BE AN ACTIVE CONTRIBUTOR

to the Regulatory team in development of regulatory strategies for assigned projects/products across all phases of product development aimed at achieving marketing authorization and appropriate product labeling

COLLABORATE

with cross-functional stakeholders on the development and execution of medical communications, marketing materials, and regulatory filings and correspondence ASSIST in planning and coordinating regulatory submissions necessary to support clinical trials, product registrations, post marketing requirements and commitments, and product-claim promotional materials SUPPORT development and preparation of annual reports, amendments, supplements, and other activities for investigational new drugs (INDs) and biologic license applications (BLAs) PREPARE for regulatory agency meetings, including meeting plan, development of briefing books, and ensuring submitted documents are high quality and compliant

COLLABORATE

with Regulatory Operations team members to establish and meet timelines for regulatory submissions

LEAD THE DEVELOPMENT

of a method for researching and communicating changes and meaningful trends in the regulatory environment in the US and pertinent international jurisdictions NETWORK across Regulatory, Medical Writing, Program Teams, Medical Affairs, Corporate Communications, and the Commercial organization to gain a thorough understanding of industry opportunities and expand upon experiences by developing and completing several projects of interest

DEVELOP KNOWLEDGE IN PREPARATION TO LEAD

review and approval of Medical and Commercial tactics in support of product launch and other initiatives

COLLABORATE

with internal teams and vendors to prepare for inspections and audits

FOSTER COLLABORATION AND LEADERSHIP SKILLS

through cross-functional projects and present information of interest to the Regulatory team and to Medical, Legal, Regulatory (MLR) committees

PARTICIPATE

in fellowship recruitment activities and interviews Qualifications Doctor of Pharmacy (PharmD) degree from an ACPE-accredited institution Eligible for pharmacist licensure in the State of Massachusetts Electives related to Regulatory Affairs a plus Excellent oral and written communication skills Strong scientific acumen, ability to understand complex scientific data, and an interest in gene editing and CRISPR Strong time management and leadership abilities Ability to work independently and take initiative on a variety of projects at both Intellia and Northeastern University Capability to be onsite at Intellia to meet with fellows and others based on team/project needs, as well as onsite Regulatory meetings quarterly Ability to travel to scientific conferences in the US Additional Information Applicants should submit the following application materials by the priority deadline of October 31, 2026: 1. Curriculum vitae (CV), uploaded 2. Unofficial PharmD transcripts, uploaded 3. Cover letter, uploaded Letters of Recommendation Three formal Letters of Recommendation (LORs) must be submitted directly by the letter writers no later than November 23, 2026 .

Each letter writer must include:

The candidate's full name The fellowship program(s) to which the candidate is applying (e.g., Smith, John - Alnylam, GSK ) Please ask your letter writers to complete and submit the Letter of Recommendation Form along with their recommendation. Click here to access the form and share it with your letter writers. Recommendations must be submitted directly by the recommender and cannot be submitted by the applicant. Address cover letter and letters of recommendation to: J. Andrew Orr-Skirvin, PharmD, BCOP Clinical Professor, Department of Pharmacy & Health Systems Sciences Pharmaceutical Industry Fellowship Program Director 360 Huntington Ave, 140 The Fenway R218 Boston, MA 02115 Northeastern University will not provide H-1B, TN, O-1, E-3, or any other type of employment visa sponsorship for the successful applicant to this position, now or in the future.

STEM OPT

is not compatible for this position. The successful applicant must be able to maintain valid work authorization in the United States throughout the entire appointment without Northeastern University's sponsorship for a visa. Position Type Research Additional Information Northeastern University considers factors such as candidate work experience, education and skills when extending an offer. Northeastern has a comprehensive benefits package for benefit eligible employees. This includes medical, vision, dental, paid time off, tuition assistance, wellness & life, retirement- as well as commuting & transportation.

Visit https:

//hr.northeastern.edu/benefits/ for more information. 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.

Compensation Grade/Pay Type:

108

S Expected Hiring Range:

$60,315.00 - $85,192.50 With the pay range(s) shown above, the starting salary will depend on several factors, which may include your education, experience, location, knowledge and expertise, and skills as well as a pay comparison to similarly-situated employees already in the role. Salary ranges are reviewed regularly and are subject to change.