Regulatory Affairs Jobs in Allston, MA
Boston Scientific Gruppe
Waltham, MA
Demonstrated experience authoring/supporting a variety of regulatory submissions for US and EU, such as original PMAs, PMA Supplements, pre-submissions, IDEs, 510(k)s and CE Design Dossiers, Tech Files, and MDR Tech Docs. Coordinates, compiles, and submits US and EU regulatory filings for new and modified products, including PMAs, PMA Supplements, pre-submissions, IDEs, 510(k)s, PMA & IDE Annual Reports, and CE Mark submissions under MDR.
Hays
Boston, MA
Experience with post-approval change management, comparability assessment, post-marketing commitments, and overall product life cycle management. Minimum of 15 total years of progressive related experience in regulatory affairs in the pharmaceutical/biotech industry.
xenon-pharma
$315000 - $350000 YEAR
Boston, MA
Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions. In addition, we are proud of the leading-edge science coming out of our discovery labs, including early-stage research programs that leverage our extensive ion channel expertise and drug discovery capabilities to identify validated drug targets and develop new product candidates.
Pharmatech Associates
Boston, MA
Advanced degree from accredited college or university in science, biomedical engineering, plus a minimum of 4 years of experience in Filing Global Regulatory Applications for pharmaceutical and Biotech products using the Lorenz docuBridge TWO submission management software. Work closely with Pharmatech and our client’s project team to be responsible for the execution of the regulatory operations related to the Lorenz docuBridge TWO submission management software relating to FDA communication and submission of regulatory documentation.
Competitive Power Ventures, Inc.
Braintree, MA
Competitive Power Ventures, Inc. (“CPV”), with headquarters in Silver Spring, MD, and offices in Braintree, MA and Sugar Land, TX, is a leading clean energy company leveraging global technology and financial partnerships to help modernize America’s power generation. Assist in executing the Company’s regulatory strategy within the PJM, MISO, SPP and other ISO/RTO footprints including market design initiatives, interconnection activities and potential growth opportunities.
Whoop, Inc.
Boston, MA
Strong written, oral, organization, problem solving, and interpersonal skills to effectively compose regulatory submissions, support audit backrooms, and complete assignments with minimal supervision. As the Quality Systems & Regulatory Affairs Specialist, you will execute regulatory strategy and support QMS maintenance deliverables for WHOOP SAMDs in a dynamic and agile environment.
WHOOP
Boston, MA
To ensure that we comply with reporting requirements and to learn more about how we can increase diversity in our candidate pool, we invite you to voluntarily provide demographic information in a confidential survey at the end of this application. This is a hybrid role, working out of our Boston, MA office 4 days per week.
Initial Therapeutics, Inc.
Waltham, MA
Additionally, this individual must have excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic regulatory strategies. Dyne has a broad pipeline for neuromuscular diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease.
Initial Therapeutics, Inc.
Waltham, MA
Visterra is seeking a Regulatory Affairs professional experienced in biologics development to lead our Regulatory Team's strategy and oversee the team’s activities from IND-enabling studies and first-in-human (FIH) studies through clinical proof of concept (PoC) trials, and to facilitate post-PoC transitioning to our Otsuka affiliate for global clinical development & commercialization. Lead and align the regulatory strategy for Visterra programs’ CMC HA submissions (e.g., compilation of M3 (CMC) sections for INDs/CTAs, CMC amendments, IMPD Amendment, annual reports, agency meeting requests, meeting briefing packages, marketing applications) appropriate to the stage of product development.
Videa Health, Inc.
Boston, MA
You will support premarket regulatory submissions for United States FDA clearances, European Union CE Mark, etc. and live out the Quality Management System (QMS) to deliver AI models with real world impact. As the QA/RA Specialist you will help shape the future of oral care by combining your own excellence in quality and regulatory processes with close collaboration with the technical Machine Learning (ML) and Operations teams.
Zenasbio
Waltham, MA
Our colleagues have an opportunity to engage in a fast-paced learning environment and experience individual and organizational success as we work towards becoming a global immunology and autoimmune disease leader, while living our values of Transparency, Relationships, Urgency, Excellence and Innovation – TRUE Innovation! With clinical development and operations globally, Zenas is advancing a deep and balanced global portfolio of potential first- and best-in-class autoimmune therapeutics in areas of high unmet medical need while meeting the value requirements of the dynamic global healthcare environment.
PSG Global Solutions
Cambridge, MA
Leads development and execution of robust global regulatory CMC strategy for assigned program(s) with balanced risk-based approach using scientific rationale and in alignment with regulatory guidance, working in collaboration with cross-functional CMC and Global Regulatory Teams to achieve program and company goals. Leads preparation, including driving strategy and content of high quality regulatory submission content focusing on chemistry, manufacturing, and control (CMC) to support global clinical development, registration, and product life cycle management.
Deciphera Pharmaceuticals, Inc.
$137000 - $189000 YEAR
Waltham, MA
This role is responsible for the supporting, or leading, regulatory submissions such as: investigational new drug applications (INDs), clinical trial applications (CTAs) and components of marketing applications as well as post-approval submissions and life-cycle maintenance activities. In this role, the Senior Manager of Regulatory Affairs will support the regulatory lead on, or lead, program related projects and be responsible for interacting with multiple functions to manage high quality regulatory submissions.
Xenon Pharmaceuticals Inc.
$139000 - $150600 YEAR
Boston, MA
Actively participate as a member of the Regulatory Affairs team on multidisciplinary project/clinical study teams by providing operational leadership and input on study documentation and procedural requirements as defined by regulatory authorities including: regulatory submission strategy, reviewing of documents and analysis of procedures used during clinical development. Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions.
VideaHealth
Boston, MA
You will lead premarket regulatory submissions for United States FDA clearances, European Union CE Mark, etc. and live out the Quality Management System (QMS) to deliver AI models with real world impact. As the Senior QA/RA Specialist you will help shape the future of oral care by combining your own excellence in quality and regulatory processes with close collaboration with the technical Machine Learning (ML) and Operations teams.
Videa Health, Inc.
Boston, MA
You will lead premarket regulatory submissions for United States FDA clearances, European Union CE Mark, etc. and live out the Quality Management System (QMS) to deliver AI models with real world impact. As the Senior QA/RA Specialist you will help shape the future of oral care by combining your own excellence in quality and regulatory processes with close collaboration with the technical Machine Learning (ML) and Operations teams.
Dyne Tx
Waltham, MA
Dyne has a broad pipeline for neuromuscular diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. Additionally, this individual must have excellent interpersonal skills, the ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, and the ability to analyze complex issues to develop relevant and realistic regulatory strategies.
Dyne Tx
Waltham, MA
Dyne has a broad pipeline for neuromuscular diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. Additionally, this individual must have excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic regulatory strategies.