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2,224

Regulatory Affairs Manager Jobs Near Boston, MA

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Salary Range

$90K

$225K

Average Salary: $143,800
Manager, Regulatory Affairs

Represent Regulatory Affairs as the SME on assigned product/ project teams and ensure timely communication of regulatory strategy and plans to team members and line management...

Posted 6d ago

  •   8 - 10 years exp.  •  Pharmaceuticals & Biotech

Manager, Regulatory Affairs

Meet regularly with direct reports to review performance, identify any issues and set expectations of goals. Prioritize and plan work activities; adapt for changing conditions...

Posted 1w ago

  •   5 - 7 years exp.  •  Healthcare

Sr. Manager, Regulatory Affairs

Maintain awareness of new and developing legislation, policy and technical regulatory guidance relating to assigned programs. Interpret existing regulations and guidance documents for regulatory...

Posted 1w ago

  •   11 - 15 years exp.  •  Pharmaceuticals & Biotech

Director, Regulatory Affairs

Responsible for assisting in the preparation and compilation of domestic and international product submissions, with guidance. This may include, but is not limited to: PMAs, 510ks, international dossi...

Posted 1w ago

  •   11 - 15 years exp.  •  Pharmaceuticals & Biotech

Senior Manager, Global Regulatory Affairs
$100K — $150K

Manage early phase development work and provide feedback on what the regulatory requirements have been for similar products

Posted 1w ago

  •   8 - 10 years exp.  •  Pharmaceuticals & Biotech

Senior Manager, Global Regulatory Affairs

Will implement EQRx’s overall regulatory strategy for the business and execute global regulatory plans that expedite development, maximize the probability of success, and mitigate risks...

Posted 4d ago

  •   5 - 7 years exp.  •  Healthcare

Director/Sr. Director, Regulatory Affairs

The Director/Sr. Director, Regulatory Affairs will implement the overall Regulatory strategy for the business and lead the clinical team in the execution of regulatory strategies for the portfolio of...

Posted 4d ago

  •   11 - 15 years exp.  •  Healthcare

Regulatory Affairs Manager

Develop global regulatory strategies that allow drug and CMC development efforts to achieve rapid regulatory approvals - with optimal product labeling - to support commercial successes...

Posted 2w ago

  •   5 - 7 years exp.  •  Pharmaceuticals & Biotech

Associate Director, Regulatory Affairs

Serve as the team representative for the US at the Global Regulatory Team for TTR programs and in other roles to assigned programs.

Posted 5d ago

  •   8 - 10 years exp.  •  Pharmaceuticals & Biotech

FDA Regulatory Affairs Professional
$80K — $100K

Provide regulatory-based scientific and statistical input in the planning and design of clinical studies (including feasibility studies), premarket clinical studies and postmarket studies in support o...

Posted 4d ago

  •   5 - 7 years exp.  •  Pharmaceuticals & Biotech

Regulatory Affairs Manager
$80K — $100K

Prepare regulatory plans and prepare needed regulatory submissions and associated documents for FDA, Health , Notified Bodies, and ROW countries and secure approvals...

Posted 2w ago

  •   5 - 7 years exp.  •  Hospitals & Medical Centers

Senior Director, Oncology Global Regulatory Affairs
$250K — $250K+

Responsible to mentor and manage a small team of Global Regulatory Affairs Team Leads (GRTLs).

Posted Yesterday

  •   15+ years exp.  •  Pharmaceuticals & Biotech

Associate Director, Regulatory Affairs

Responsible for day-to-day engagement with product Regulatory Leads and/or project teams to support the regulatory aspects of all clinical and/or CMC development programs...

Posted 6d ago

  •   8 - 10 years exp.  •  Pharmaceuticals & Biotech

Senior Manager, Regulatory Affairs (Data Products)

Manage internal and external communications focused on regulatory considerations for data products, including real world data (RWD), AI/ML algorithms, SaMDs and CDSs...

Posted 1w ago

  •   5 - 7 years exp.  •  Pharmaceuticals & Biotech

Associate Director, Regulatory Affairs

Develop and maintain effective relationships with regulatory agency personnel, regulatory experts, and consultants to optimize regulatory outcomes.

Posted 1w ago

  •   5 - 7 years exp.  •  Pharmaceuticals & Biotech

Manager/Senior Manager, Regulatory Affairs

Represent Regulatory Affairs on multi-disciplinary project teams and provide regulatory guidance on development plans.

Posted 2w ago

  •   5 - 7 years exp.  •  Pharmaceuticals & Biotech

Regulatory Affairs, Sr Manager/Director

Interface with FDA, CE, and other regulatory agencies regarding regulatory submission strategy and approval reviews, as per company marketing plans...

Posted 2w ago

  •   8 - 10 years exp.  •  Healthcare

VP, Regulatory Affairs

Excellent oral communication and writing skills Change management/ change enabler : embraces the challenges of a fast changing environment

Posted 2w ago

  •   15+ years exp.  •  Pharmaceuticals & Biotech

Director, Quality Assurance and Regulatory Affairs

Ensure proper and timely preparation and maintenance of national and international new product submissions, registration/licensing renewals, product listings, post market surveillance reports, import...

Posted Today

  •   15+ years exp.  •  Pharmaceuticals & Biotech

Associate Director/Director, Regulatory Affairs

Work independently with minimal direction and within project teams, committees, etc. to attain group goals.

Posted 5d ago

  •   5 - 7 years exp.  •  Pharmaceuticals & Biotech

Senior Director, Regulatory Affairs

You will develop briefing packages, fast track applications, orphan drug applications for meetings with FDA and other global health authorities.

Posted 1w ago

  •   11 - 15 years exp.  •  Finance & Insurance

Director, Global Regulatory Affairs - Neuroscience

Participates with influence in or leads departmental and cross-functional task-forces and initiatives.

Posted 1w ago

  •   11 - 15 years exp.  •  Pharmaceuticals & Biotech

Associate Directr/Director, Regulatory Affairs CMC

Independently provide strategic guidance/input related to current regulatory requirements and expectation for cell therapy clinical trial and marketing applications...

Posted Today

  •   5 - 7 years exp.  •  Pharmaceuticals & Biotech

easy-apply-job

EASY APPLY

Associate Director / Director, Regulatory Affairs
$200K — $350K + tbd

Provide regulatory leadership and guidance to Commercial teams during the development, review and approval of product labeling and advertising materials; provide a leadership role on the review commit...

Posted 2w ago

by Jitendra Kushwah

  •   8 - 10 years exp.  •  Pharmaceuticals & Biotech

Senior Director of Regulatory Affairs Compliance AdProm
$200K — $250K

Collaborates with multidisciplinary teams to ensure materials are consistent with FDA regulations and approved product labeling while meeting strategic promotional objectives...

Posted 5d ago

  •   11 - 15 years exp.  •  Pharmaceuticals & Biotech

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