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Regulatory Affairs Manager
1 week ago
Octapharma AG New York, United StatesTab drcken, um zum Link "Weiter zu Inhalt" zu gelangen · Whlen Sie aus, wie oft (in Tagen) Sie eine Benachrichtigung erhalten mchten: · Whlen Sie aus, wie oft (in Tagen) Sie eine Benachrichtigung erhalten mchten: · Regulatory Affairs Manager (m/w/d) - befristet bis Mrz 2026 · ...
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Regulatory Affairs
1 week ago
Marubeni America New York, United States**Regulatory Affairs & Customer Service Manager - Agri-Input Dept. - Agri Input Unit** · MAC Agri Input Unit HARR 500 Mamaroneck Avenue, 500 Mamaroneck Avenue, Harrison, New York, United States of America Req #33 Thursday, January 27, 2022 Marubeni America Corporation Regulatory ...
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Regulatory Affairs
4 days ago
AA2IT New York, United StatesJob Title: Regulatory Affairs - Animal Health · Location: Rahway, NJ - Onsite from day 1 · Pay Rate: $42/hr · Duration: 11 Months · We are inviting applications for the role of CMC 2 Regulatory affairs. · Responsibilities: · Well versed in performing CMC compliance activiti ...
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Director, Regulatory Affairs
6 hours ago
Mitsubishi Tanabe Pharma Jersey City, United StatesOverview: · Entrepreneurial Spirit, Rooted in Tradition. Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a U.S. subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC) in Japan, which touts a storied reputation more than 300 years in the making. Our parent company - one of Ja ...
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Director of Regulatory Affairs
3 days ago
X4 Life Sciences New Jersey, United StatesA long term consulting client of X4 Life Sciences is looking to add a Regulatory Affairs Subject Matter Expert to their division, · Our client are an expert in providing their clients with solutions to their most difficult drug development challenges as well as regulatory framewo ...
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Head of Regulatory Affairs
3 days ago
EPM Scientific New Jersey, United StatesOur client, a clinical stage biotech company, is seeking an experienced and dynamic Head of Regulatory Affairs to join their growing team. This exciting opportunity offers the chance for a leader with clinical regulatory affairs experience to take on a hands-on leadership role. T ...
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VP of Regulatory Affairs
5 days ago
Leaman Life Sciences New York, United StatesVP of Regulatory Affairs · I am partnered with a scientifically driven late-stage, well funded biopharmaceutical company who are looking to build out their Solid Tumors pipeline. · They are looking for a Vice President of Clinical Regulatory Affairs to be responsible for the dev ...
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Regulatory Affairs Specialist
2 weeks ago
Katalyst Healthcares and Life Sciences Hoboken, United StatesResponsibilities Responsible for the coordination and preparation of document packages for regulatory submissions from all areas of the Company. · Keeps abreast of regulatory procedures and changes. · Coordinates the collection of documents, records, reports, and data from the ...
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CUSO Regulatory Affairs
7 hours ago
Credit Agricole New York, United StatesSummary: · The Regulatory Affairs team is responsible for coordinating and facilitating communications between the Bank and its various regulators on behalf of all US business operations and entities, as well as for coordinating the regulatory remediation efforts within the regio ...
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CUSO Regulatory Affairs
1 week ago
Crédit Agricole CIB Limited New York, United StatesVacancy details · General information · Entity · About Crdit Agricole Corporate and Investment Bank (Crdit Agricole CIB) · Crdit Agricole CIB is the corporate and investment banking arm of Crdit Agricole Group, the 10th largest banking group worldwide in terms of balance sheet s ...
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Director, Regulatory Affairs
1 week ago
Scismic Inc New York, United StatesJob Description · Job DescriptionScismic is supporting the growth of a late-stage, publicly traded biopharmaceutical company developing targeted radiotherapies to deliver cancer-killing radiation with cellular level precision to treat patients with high unmet medical needs. · The ...
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Associate Director, Regulatory Affairs
2 weeks ago
Organon Jersey City, United States Full timeJob Description · The Position · The Associate Principal Scientist is responsible for developing and implementing Regulatory Chemistry, Manufacturing and Controls (CMC) strategies for assigned small molecule products in accordance with global regulations and guidance's, and Compa ...
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Head of Regulatory Affairs
1 day ago
Merkle Science New York, United StatesAbout Merkle Science · Merkle Science provides blockchain transaction monitoring and intelligence solutions for web3 companies, digital asset service providers, financial institutions, law enforcement and government agencies to detect, investigate, and prevent illicit use of cry ...
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Regulatory Affairs Associate
2 weeks ago
Atrium Staffing New York, United StatesAbout Atrium: · What you do matters. As a people-centric organization, we foster an environment of collaboration, high-performance and innovation where your talents are valued, and your achievements are celebrated. Join us and become part of an inclusive team. · Client Overview ...
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Specialist, Regulatory Affairs
2 weeks ago
Shiseido Newark, United StatesSelect how often (in days) to receive an alert:Specialist, Regulatory Affairs Date: May 9, 2024Job Summary:The Specialist in Regulatory Affairs will be assigned to the Risk Analysis and Strategy group. Responsible for ensuring regulatory compliance of raw materials, formulas and ...
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Vice President Regulatory Affairs
5 days ago
CSG Talent New York, United StatesVice President of Regulatory Affairs · My client is a Top 10 Pharma looking for a new VP Regulatory affairs. They have been a secure fortune 500 company for many years and are expanding their team across the US and globally. With over 2000 employees they have a track record of le ...
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VP, Regulatory Affairs Specialist
1 week ago
Jefferies Jersey City, United StatesJob Description · Regulatory Affairs Specialist · Position · This hire will be a member of the Firm's Regulatory group which is responsible for exam oversight, branch inspections, regulatory change tracking, governance related tasks and additional ad-hoc tasks. The Firm's Regul ...
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Lead Regulatory Affairs Associate
5 days ago
Navitas Life Sciences New Jersey, United StatesJob Title: Lead Regulatory Affairs · Work Location: US – EST, CST time zone. · Reports To: Practice Head - Regulatory · Job Description: · Develop and manage day-to-day operations using project management and planning tools, create and maintain detailed project timelines · Est ...
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Senior Director Regulatory Affairs
4 days ago
SciPro New Jersey, United StatesOur client, an exciting and growing Biotech Company, is seeking a Regulatory Affairs professional at the Senior Director level. This role will lead the North America regulatory strategy and work extremely closely with the C-Suite leaders of the business. They are focused on Autoi ...
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Quality & Regulatory Affairs Manager
5 days ago
The Brooklyn Hospital New York, United StatesSalary Range: $135,000 - $155,000 Per Year · Are you skilled at collaborating effectively? · Because, in this important role, you'll lead, guide, motivate and work with staff on new methods, key policies, and regulatory requirements. Your industry knowledge will be crucial in ens ...
Director of Regulatory Affairs - Jersey City, United States - KMR Search Group
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Description
Job DescriptionThe Director US Regulatory Affairs supports the contract development and manufacturing of client cell therapy products for the US market.
This individual collaborates cross-functionally to support client projects, including support for submissions, coordinating pre-approval inspections, and managing compliant licensing for all facilities supplying the US market.
This individual also creates and maintains systems by which regulatory documentation is created, approved, submitted, and maintained.Essential Functions and Responsibilities
Coordinate projects and activities across regulatory support functions in Europe and Japan in order to formalize and harmonize regulatory processes, procedures, and infrastructure across the network.
Responsible to maintain up to date knowledge of regulatory requirements for cell therapy products in both clinical and commercial phases and communicate changes in requirements through the organization.
Plan, coordinate, author, and review any submissions to FDA to ensure company requirements and relevant FDA requirements are met.Liaise with Project Managers and participate on global client project teams to properly plan for and support client submissions to regulatory agencies, including but not limited to strategies for technology transfer, process and method validation, and stability.
Participate in due diligence activities for potential licensing opportunities and acquisitions.Manage GMP licensing for North America sites and supports global sites in obtaining appropriate licenses to market product in the US.
Critically review complex reports and change control documentation for regulatory and risk mitigation strategies.Ensure compliance to Pharmacopeia through monitoring of changes and careful implementation at sites.
Develop relationships with Health Authorities through external engagement via professional organizations, conferences, and committees.
Coordinate across Global Quality and across Sites to support inspection coordination in order to obtain the appropriate GMP certifications for each site.
Work with the Global Head of Quality and Regulatory to plan for the long-term strategy and development of the Regulatory Affairs Department, including the development of client service offerings.
Provide regulatory training to site level associates as a Subject Matter Expert Partner with the Global Quality Systems organization in order to maintain the accuracy of the Global Quality Manual and Standards.
Provide review of Global Quality Manual and Standards, as well as global and regional SOPs as required in order to verify compliance to regulatory expectations and standards.
CompetenciesExcellent collaboration, agility, and adaptability
Strong leadership skills including influencing ability, driving results, commitment and execution, working in teams and a matrix environment
Demonstrated history of strong decision making
Well organized, adept at planning and working effectively within cross-disciplinary teams
Excellent oral, written, and verbal communication skills are required
Strong computer skills are required
Qualifications
BA/BS in the Life Sciences is required.
MS or PhD in chemistry or biology and/or Regulatory Affairs is strongly preferred.
Minimum 7-10 years in Regulatory Affairs in an FDA Regulated Industry is required
Thorough knowledge of ICH Guidelines and FDA cGMPs and Guidelines is required.
Knowledge of European and Japanese Health Authority requirements is strongly preferred
Chemistry and Manufacturing Control (CMC) Regulatory experience is a must.
Regulatory Affairs Certification preferred
Ability to work independently with minimal supervision is required
Proven interpersonal skills with face to face and remote teams
Minimum Required Training
Incumbent will be expected to complete all assigned GxP and Compliance related training in accordance with assigned due dates.
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