1,591 Results for

Regulatory Affairs Jobs in Westwood, MA

Jobs

Medical Affairs/Safety - Manager, PV Scientist - Contract TalentBurst, Inc.

Cambridge, MA

$113.55 / hour

Collaborates proactively with study teams, cross-functional team members, external business partners and vendors to apply knowledge and analytical skills to problems in specific therapeutic areas. Contributes to activities related to the functioning of safety committees, including but not limited to, preparing reports, minutes and meeting documents; ensuring completion of action items; and, participating in the discussion of patient safety issues.

4 days ago

Manager, Regional Regulatory Lead - LCM CSL

Waltham, MA

$129,000–$153,000 / year

Developing regional knowledge regarding health authority requirements, regulatory filing pathway/categories, processes, and ways of working and thus, can provide relevant guidance / assessment to internal stakeholders (e.g., GRAST, GRL & Commercial) on means to address project challenges, leverage regulatory opportunities and advise on risk for developmental, new, and marketed products. Regulatory leaders who leverage regional regulatory experience to actively contribute to an innovative, scientifically sound, global, integrated regulatory vision/strategies for assigned product/s with a patient-centric focus, leveraging regional commercial insights and applying prudent risk-taking to ensure timely delivery of successful regulatory outcomes.

6 days ago

Senior Payroll Specialist Bryant University

Smithfield, RI

Full time

In partnership with the Director, Employee Benefits, Wellbeing, and Payroll, the Senior Payroll Specialist evaluates payroll operations, identifies opportunities for process improvement and operational efficiency, recommends strategic enhancements, and supports the implementation of technology solutions and best practices that strengthen payroll service delivery. The Senior Payroll Specialist functions as the first point of escalation for complex payroll issues, conducts research and analysis to resolve discrepancies, and provides functional leadership, technical guidance, training, and operational support to the Payroll and HR Coordinator.

13 days ago

Senior Manager Supply Chain - Contract TalentBurst, Inc.

Marlborough, MA

Remote

$60–$70.18 / hour

S&OP process Responsible for all aspects of supply management inclusive of planning, sourcing, logistics and supplier relations in support of commercial and late stage clinical products, Develop and maintain accurate demand forecasts for pharmaceutical products, incorporating market trends, promotional activities, and regulatory considerations. Lead/Support multiple initiatives related to supply chain management, with focus on systems and processes that support Supply Chain organization (planning software, ERP utilization, product strategy, Logistics, etc.).

9 days ago

US_Drug Safety Consultant II - Contract TalentBurst, Inc.

Cambridge, MA

$79.61 / hour

Position Summary The PV Aggregate Reports Scientist is part of the Safety Surveillance and Aggregate (SSA) Reports team and is responsible for managing the processes for all aggregate reports (PSURs, DSURs, PADERs, and local reports). Schedule & Regulatory Oversight: Support the Aggregate Reports Master Schedule (production, updates, stakeholder reviews), conduct worldwide legislation reviews for aggregate reporting, and provide impact assessments.

13 days ago

Sr. Network Architect ECLARO

Boston, MA

Strong hands-on knowledge of LAN/WAN protocols and technologies including Carrier Ethernet, T1, DS3, optical, DWDM, NTP, Spanning Tree, VLAN's, 802.1q, VFR, LFA, SMTP, SNMP v1-v3, OSPF, BGP, MPLS, VPLS, Ethernet, TCP/IP, SSL, SSH, SIP, H.323, QoS, Multicast, Anycast, 802.1x, Radius, NAC, DHCP, DNS, F5 Wide-IP, VRRP, HSRP, GLBP, PBR, VPC, LACP, SGT, SGACL, SXP, VxLAN, OTP, LISP, SPAN, WCCP, PfR, IPSLA, iWAN, VPN, IPSec, Wi-Fi 6, 6E, 7. Proven experience and success with planning, installing and managing networks including LAN, MAN, WAN, Optical Networking, DWDM, Wi-Fi, Silverpeak SDWAN or Riverbed WAN Optimizers, F5 Load Balancers, F5 GTM Global Traffic Manager, Cisco Catalyst Center, and security (firewalls, VPN, DMZ, IDS/IPS, WebProxy, content filter, FireEye, NAC and Cisco TrustSec) infrastructure.

3 days ago

Pathologist Assistant - Boston, MA KA Recruiting Inc.

Boston, MA

Job Description Pathologist Assistant - Boston, MA - Permanent and Full-Time Hire POSITION SUMMARY: Under the general supervision of a Pathologist or the Managing Pathologist Assistant, the Pathologists' Assistant - Certified performs various duties related to accessions, preparation, and performance of human specimen dissection and postmortem examinations. CERTIFICATES, LICENSES, REGISTRATIONS REQUIRED: Pathologist Assistant PA (ASCP) Certification required within 6 months of hire.

2 days ago

Senior Director Regulatory Affairs Liaison- General Medicine Merck & Co Inc

Boston, MA

$190,800–$300,300 / year

Required Skills: Corporate Commercial, Cross-Cultural Awareness, Drug Development, Exercises Judgment, Global Health, Global Market, Healthcare Innovation, Interpersonal Relationships, In Vitro Diagnostics (IVD), Multiple Therapeutic Areas, Oral Communications, Orphan Drugs, Pharmaceutical Regulatory Affairs, Process Improvements, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Issues, Regulatory Management, Regulatory Strategy Development, Written Communication. As the Global Regulatory Lead (GRL), the Senior Principal Scientist functions as the regulatory single, accountable, global point of contact on the project team and interacts with the global regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more company investigational and marketed drugs/biologics in early- and/or late-stage development.

30+ days ago

Staff Regulatory Affairs Associate (Digital Health & AI Technologies) Whoop

Boston, Massachusetts

At WHOOP, we view total compensation as the combination of base salary, equity, and benefits, with equity serving as a key differentiator that aligns our employees with the long-term success of the company and allows every member of our corporate team to own part of WHOOP and share in the company’s long-term growth and success. Partner with Product, Engineering, and AI/ML teams to evaluate regulatory implications of new features, algorithms, health insights, claims, intended uses, and user experiences, and recommend appropriate regulatory and claims strategies.

30+ days ago

Staff Regulatory Affairs Associate (Digital Health & AI Technologies) Whoop Inc

Boston, MA

$170,000–$220,000 / year

At WHOOP, we view total compensation as the combination of base salary, equity, and benefits, with equity serving as a key differentiator that aligns our employees with the long-term success of the company and allows every member of our corporate team to own part of WHOOP and share in the company's long-term growth and success. Partner with Product, Engineering, and AI/ML teams to evaluate regulatory implications of new features, algorithms, health insights, claims, intended uses, and user experiences, and recommend appropriate regulatory and claims strategies.

30+ days ago

Associate Director Regulatory Affairs Viridian Therapeutics Inc

Waltham, MA

Reporting to the Senior Director, Regulatory Affairs, the Associate Director, Regulatory Affairs will represent Regulatory Affairs on assigned cross-functional teams and lead day-to-day regulatory activities for product development and approval in alignment with the corporate strategy for Viridian's Thyroid Eye Disease (TED) and TSHR portfolio. Communicate with internal and external stakeholders, including members of the leadership teams, to ensure cross-functional alignment, work with Regulatory CMC and Regulatory Operations teams to establish and meet timelines for regulatory submissions.

30+ days ago

Director of Regulatory Affairs, Post-Market Compliance Werfen

Bedford, Massachusetts

$200,000–$240,000 / year
Full time

Reporting to the Senior Director of Regulatory Affairs, this position is responsible for ensuring worldwide regulatory compliance of commercially distributed products through effective management of vigilance reporting, field actions, post-market surveillance activities, regulatory assessments, and product lifecycle compliance programs. The Director serves as the regulatory leader for post-market compliance activities and collaborates closely with Quality Assurance, Medical Affairs, R&D, Operations, Manufacturing, Supply Chain, and Commercial teams to ensure timely identification, assessment, communication, and resolution of product-related regulatory issues.

13 days ago

Manager, Regulatory Affairs Program Canadian Nuclear Laboratories Ltd

Burlington, MA

Managing the work of and leading technical specialists within the Branch, elsewhere within CNL, and external to CNL (as required) to ensure that requests for independent technical review of technical documentation submitted by Proponents, or requests by Proponents for independent review of activities at nuclear facilities at CNL sites, are accommodated and dispositioned effectively and efficiently with due regard to timely review while maintaining technical breadth and depth and not compromising safety. In consultation with the SRC Secretariat and Proponents, planning independent technical reviews, accepting hazard categories following the review of proposals by Proponents, liaising with the NCS Panel Chair and the NCS Panel Technical Secretary, chairing SRC independent technical review meetings, and ensuring that final review comments that are compiled from SRC technical reviewers are consistent and harmonized before they are sent to the Proponents.

25 days ago

Assoc. Director, Regulatory Affairs Advertising and Promotion Definium Therapeutics Inc

Boston, MA

$160,000–$190,000 / year

Our lead product candidate, lysergide tartrate (our proprietary orally disintegrating tablet form of lysergide (LSD) D-tartrate), represents a highly differentiated, potential best-in-class opportunity for patients suffering from generalized anxiety, major depressive disorder, and posttraumatic stress disorder. Provides input into labeling strategies for investigational and marketed products and is responsible for leading interactions with the FDA Office of Prescription Drug Promotion (OPDP) and Advertising and Promotion Labeling Branch (APLB) pertinent to assigned brand(s).

30 days ago

Associate Director / Director, Regulatory Affairs Treeline Biosciences, Inc.

Watertown, MA

$175,000–$206,015 / year

Contribute to (Associate Director) or hold final accountability for (Director) regulatory documentation, ensuring adherence to FDA and other global health authority specifications and timelines, including submissions, correspondence, and approvals, and ensuring accurate and organized records. Unsolicited resumes sent to Treeline Biosciences from recruiters do not constitute any type of relationship between the recruiter and Treeline Biosciences and do not obligate Treeline Biosciences in any way to pay fees should we hire from those resumes.

30+ days ago

Associate Director / Director, Regulatory Affairs Treeline Biosciences Inc

Watertown, MA

30+ days ago

Associate Director Regulatory Affairs Alnylam Pharmaceuticals Inc

Cambridge, MA

$170,900–$231,300 / year

The Associate Director of Regulatory Affairs Strategy will work on assigned programs with the respective Global Regulatory Portfolio Lead, Global Regulatory Lead and cross-functional team to lead and define the regulatory strategy, facilitate submission of data packages to the US FDA and other international health agencies (HA). Additional responsibilities include involvement in thewriting and oversight of regulatory submissions, coordinating all aspects of paper and electronic regulatory submissions, proactively keeping updated on regulatory requirements worldwide, and interpreting regulatory intelligence for the internal teams.

11 days ago

Associate Director Regulatory Affairs, Oncology GSK plc

Waltham, MA

$138,750–$231,250 / year

This role will ensure the development of appropriate global and/or regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy /Integrated Asset plan to ensure the development program meets the needs of the key markets identified and the Medicines Profile. Work with the Early/Medicine Development Team (EDT/MDT) or GRL, to ensure a robust regulatory strategy is in place to support the development program to meet the needs of the key markets identified in the Integrated Asset plan and the Medicine Profile.

30+ days ago

Senior Regulatory Affairs Specialist Boston Scientific Corp

Marlborough, MA

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com-will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Your responsibilities will include: Reviews change notifications and performs regulatory impact assessment for product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings, and supports associated global submissions as needed.

30+ days ago

Director, Global Regulatory Affairs, Neuroscience 3316 Takeda Development Center Americas

Boston, Massachusetts

Demonstrates acceptable 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. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible.

12 days ago

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Regulatory Affairs Jobs in Westwood, MA

Medical Affairs/Safety - Manager, PV Scientist - Contract TalentBurst, Inc.

Manager, Regional Regulatory Lead - LCM CSL

Senior Payroll Specialist Bryant University

Senior Manager Supply Chain - Contract TalentBurst, Inc.

US_Drug Safety Consultant II - Contract TalentBurst, Inc.

Sr. Network Architect ECLARO

Pathologist Assistant - Boston, MA KA Recruiting Inc.

Senior Director Regulatory Affairs Liaison- General Medicine Merck & Co Inc

Staff Regulatory Affairs Associate (Digital Health & AI Technologies) Whoop

Staff Regulatory Affairs Associate (Digital Health & AI Technologies) Whoop Inc

Associate Director Regulatory Affairs Viridian Therapeutics Inc

Director of Regulatory Affairs, Post-Market Compliance Werfen

Manager, Regulatory Affairs Program Canadian Nuclear Laboratories Ltd

Assoc. Director, Regulatory Affairs Advertising and Promotion Definium Therapeutics Inc

Associate Director / Director, Regulatory Affairs Treeline Biosciences, Inc.

Associate Director / Director, Regulatory Affairs Treeline Biosciences Inc

Associate Director Regulatory Affairs Alnylam Pharmaceuticals Inc

Associate Director Regulatory Affairs, Oncology GSK plc

Senior Regulatory Affairs Specialist Boston Scientific Corp

Director, Global Regulatory Affairs, Neuroscience 3316 Takeda Development Center Americas

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