REMOTE Regulatory Affairs jobs

Job Description The Manager, Regulatory Affairs provides regulatory support for oncology products in early- and late-stage development. In this role, the Manager of Regulatory Affairs will support the regulatory lead on program related projects and be responsible for interacting with multiple functions to manage high quality regulatory submissions.  This...

Job Description Manager, Global Regulatory Affairs About This Role The Global Regulatory Affairs Manager, works closely with Global and Regional Regulatory Leads providing support for a variety of regulatory activities for development and marketed products. You are a member of the Regulatory Project Team for assigned programs and work with direction from...

Our passion. Our purpose. At Corbus, it starts at our core. We look for unique talent. Our people are brilliant, they break barriers and are not defined by a title. Eclectic experiences make Corbus a special place to share ideas and grow. At Corbus, transformative ideas can come from anyone, anywhere and anytime. We offer our team flexibility and the...

The Regulatory Affairs Intern will support the Regulatory Affairs team in daily tasks, projects, and FDA submission activities including: Assist in drafting, organizing, and editing regulatory documents for 510(k) submissions. Coordinate workflow for regulatory document reviews (internal and external) within submission timelines. Coordinate with...

At Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing. We believe our people are at...

Job Description General Description: As a pivotal member of the Corbus Product Development Team(s) (PDT) supports Corbus’ drug development by developing and overseeing the execution of regulatory strategy in the US/EU and other territories deemed applicable.  Responsibilities: Collaborate with the leadership team to develop Regulatory Strategy as...

Overview: POSITION SUMMARY:  Under the direction of the Director or designee, the Regulatory and Compliance Specialist I is responsible for ensuring research regulatory affairs and compliance with federal and state regulations and institutional policies and procedures. Responsibilities: ESSENTIAL DUTIES: Gather data, review, and triage the submissions...

Job Description About the role: The Senior Director, Global Regulatory Strategy, Therapeutic Area Lead in Global Regulatory Affairs is responsible for the development of end-to-end US, Above-Country EU and Global regulatory strategies for assigned programs from R2D transition through lifecycle management supporting the neuromuscular and rare disease...

Job Description Job Responsibilities:   This role is responsible for all business affairs and financial oversight of productions for all regional Agency clients, and provides general oversight and continuity across all lines of business.   As Vice President/Director, Business Affairs, you will be the go-to expert and primary point of contact for the...

The Public Affairs & Communications Associate will be passionate about telling the Massachusetts Life Sciences Center’s (MLSC) story and promoting our mission of supporting the growth and development of the life sciences in Massachusetts. In particular, this individual will serve as a voice of the MLSC brand by contributing and optimizing to the MLSC’s...

Job Description Location: This role is remote in the United States with occasional travel to Sobi sites for business-critical meetings/events. Candidates on the US East coast prefered.  The Senior Director Global Regulatory Advertising & Promotion will report to the Head of the Global Regulatory Compliance, Operations, Labeling and AdPromo (COLAP) and...

Job Description The NA Regulatory Advertising and Promotion Senior Manager will report to the Head of Global Regulatory Advertising & Promotion. As a voting member of the Review Committee, the regulatory representative will assess materials for regulatory context and provide regulatory interpretations of applicable guidance and/or regulations, or regulatory...

Job Description About This Role  This role is responsible for Regulatory CMC expertise into the development and implementation of the global regulatory strategy, operations and planning for the CMC aspects of assigned projects/products. Responsibilities include preparation and compilation of submission/documentation for specific antisense oligonucleotide...

Job Description The Director, Global Regulatory Lead, is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area.   Leads the Global Regulatory Product Team (GRPT).  Continually expands TA knowledge, and ensures strategic messaging and content of global...

About the position We are looking for a (Senior) Medical Director, Oncology TA Head to lead and oversee the medical strategy for the oncology therapeutic area. You will play a crucial role in the development and implementation of clinical programs and provide medical expertise to support the overall therapeutic area strategy. First-in-human Phase 1 and...

Job Description HR Coordinator Job Opportunity HR Coordinator Contract Opportunity | In-Office Role About this Position: The HR Coordinator provides important support to HR Shared Services. Responsibilities include sorting mail, managing personnel files, and assisting with HR case management. Job Responsibilities: Handle printing, sorting, faxing, and...

Job Description IT Support Specialist This is a contract opportunity for Year Up Alumni. This is an in person opportunity.   About this Position We are seeking a highly skilled and proactive IT Support Professional to join our team. As the first point of contact for computer hardware, software, network, and telecommunications issues, you will play a...

Job Description About This Role The Associate Director, Marketing, Patient Engagement, Rare Disease - Friedreich's ataxia(FA) position will be a critical role and visible leader within the North American Organization leading the overall Patient/Consumer strategies to find and activate patients, drive educational efforts and messaging for patients and...

Job Description Data Scientist This is a contract opportunity. This is an remote opportunity open to candidates who reside in Boston, MA, New York, NY or Chicago, IL.   About the Position: As a Data Scientist, you will play a crucial role in our team by leveraging your expertise in statistics, machine learning, programming, and data...

Job Description About This Role The Senior Manager, Scientific Communications is a member of the Global Scientific Capabilities department within Medical Affairs and is responsible for the strategic planning and execution of high-quality scientific communications deliverables. This person will report to the Director, Scientific Communications for Rare...