Regulatory Affairs Jobs in Brighton, 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.
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.
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.
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.
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.
Repligen Corporation
Waltham, MA
This senior leadership position will be required to participate in business reviews, external forums and support customer interactions, as necessary, including acting as spokesperson for Repligen Regulatory Compliance with governmental entities and global regulators. This role will be accountable for the Regulatory oversight of all Repligen products and will be responsible for leading and developing a team of regulatory subject matter experts.
Lantheus
Bedford, MA
Serve as a strategic partner to internal stakeholders including Commercial, Medical Affairs, Corporate Communications, Legal and Compliance providing regulatory guidance and perspectives on key business strategies, objectives and tactics. Lead the regulatory review as a member of a multidisciplinary medical, legal and regulatory review team of the promotional and medical communications for the assigned Lantheus product(s) ensuring they comply with FDA regulations, guidance, and company policies.
Santander Holdings USA Inc
$101250 - $185000 YEAR
Boston, MA
Skills and Abilities: Requires a thorough understanding of Groups US operating entities, including their respective lines of business and corporate functions, as well as participation in all facets of management of examinations and reviews of Groups US operating entities. See Santander Privacy Policy at https://tbcdn.talentbrew.com/company/1771/v3_0/pdf/2022-SANUS-Employee-Privacy-Notice-12-21-2022-Final.pdf and SonicJobs Privacy Policy at https://www.sonicjobs.com/us/privacy-policy and Terms of Use at https://www.sonicjobs.com/us/terms-conditions.
Vertex Pharmaceuticals Inc (US)
$140200 - $210300 YEAR
Boston, MA
This role also acts as a resource for regulatory support and guidance to various cross-functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into investigational and commercial programs. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.
Santander Holdings USA Inc
$90000 - $165000 YEAR
Boston, MA
Essential Functions/Responsibility Statements: Ability to lead and coordinate across cross functional risk teams to ensure alignment, support requirements/traceability reviews including testing and validation, and produce program level risk reporting for executive leadership. Serves as a subject matter expert to ensure documents, projects, processes or product initiatives comply with regulatory and legal requirements and enterprise policy.
The Borgen Project
Cambridge, MA
With 20 years of experience in the advocacy space, The Borgen Project has worked to support the passage of numerous bills that have benefitted close to 500 million people in developing countries. The Borgen Project is an international organization that works at the political level to improve living conditions for people impacted by war, famine and poverty.
Veeva Systems, Inc.
$80000 - $200000 YEAR
Boston, MA
Direct experience with systems such as Veeva Vault, PAREXEL/LIQUENT InSight, CSC Regulatory Tracker, ArisGlobal Register, OpenText, SharePoint, Documentum, FirstDoc/FirstPoint, NextDocs, CARA, Salesforce, Workday, Oracle, SAP, Lorenz Docubridge, Extedo eCTD Manager, Master Control, Trackwise, other regulatory information management or submission publishing systems. As a key member of our Professional Services team, the Senior Consultant will be responsible for understanding our customers’ global regulatory needs, translating requirements into solution design, and defining global strategies for deploying our cloud-based solution for managing regulatory information across the enterprise.
Initial Therapeutics, Inc.
Boston, MA
Demonstrates strong skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
Voisinconsulting
Boston, MA
VCLS is seeking a seasoned Regulatory Science Director with deep expertise in Advanced Therapy Medicinal Products (ATMPs) to lead strategic regulatory development for cutting-edge cell and gene therapies. Provide expert regulatory guidance across the full lifecycle of ATMPs.
Takeda
$174500 - $274230 YEAR
Boston, MA
Creates high quality, complaint regulatory documents (e.g., BLAs, INDs, CTAs, MAAs, Variations/Supplements and other relevant regulatory filings such as PIPs/PSPs, ODDs, meeting requests and briefing packages) for assigned programs within defined timelines as per R&D and business objectives. Leads and manages FDA health authority interactions/meetings related to assigned programs and supports regional and local regulatory affairs teams with health authority interactions.
Xenon Pharmaceuticals Inc.
$164300 - $207800 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.
Vertex Pharmaceuticals Inc (US)
$161600 - $242300 YEAR
Boston, MA
In this Remote-Eligible role, you can choose to be designated as: Remote: work remotely five days per week and come into the office on occasion – you’re always welcome on-site; Hybrid: work remotely up to two days per week; On-Site: work five days per week on-site with ad hoc flexibility. Contributes to labeling strategy with a proficient ability to advise stakeholders of regulatory labeling requirements for quality, preclinical and clinical data and oversight of health authority interactions (responses to questions, negotiations, and inspections) regarding all aspects of labeling.
Keller Executive Search
$160000 - $210000 YEAR
Boston, MA
Compensation: Comprehensive compensation package with base salary of between $160,000 to $210,000 depending on experience, premium health benefits, flexible work arrangements, substantial parental leave, executive development allowance, and retirement benefits. This position will be responsible for developing and implementing programs that enhance the quality of life for veterans while advocating for their needs at local, state, and national levels.