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VP, Regulatory Affairs
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Regulatory Affairs Consultant
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Manager, Regulatory Affairs
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Regulatory Affairs Specialist III
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Director Regulatory Affairs-CMC
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Head, Global Regulatory Affairs
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Director/Senior Director Regulatory Affairs
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Senior Manager Regional Regulatory Affairs
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Manager/Sr. Manager, Regulatory Affairs CMC
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EPM Scientific Oklahoma City, United StatesTitle: · Associate Director, Regulatory Affairs Advertising & Promotion · The Associate Director, Regulatory Affairs Advertising & Promotion will be responsible for providing strategic, operational and tactical regulatory advice to internal stakeholders regarding communications ...
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Corbus Pharmaceuticals Oklahoma City, United StatesSenior Director/Director, Global Regulatory Affairs · Full-time · Our passion. Our purpose. At Corbus, it starts at our core. · We look for unique talent. Our people are brilliant, they break barriers and are not defined by a title. Eclectic experiences make Corbus a special pla ...
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ACIP Oklahoma City, United StatesNanobiotix – a brief history · Est. 2003, Nanobiotix is a clinical-stage biotechnology company focused on developing first-in- · class product candidates that use proprietary nanotechnology to transform cancer treatment. · Headquartered in Paris (c.70 staff) and with a US affilia ...
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Executive Director, Medical Affairs
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Sr. MSL II, Glaucoma and Retina
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Sr. MSL II, Glaucoma and Retina
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Director of Quality
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Tower Riggers
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Associate Director, Global Labeling
6 days ago
Takeda Oklahoma City, United StatesBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that · the information I provide in my application will be processed in line with · Takeda's · Privacy Notice · and · Terms of Use . · I further attest that all ...
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Medical Director
2 weeks ago
Avetix Group Oklahoma City, United StatesAbout the position · We are looking for a (Senior) Medical Director, Oncology TA Head to lead and oversee the medical strategy for the oncology therapeutic area. You will play a crucial role in the development and implementation of clinical programs and provide medical expertise ...
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Clarivate Oklahoma City, United StatesClarivate is a leading global provider of transformative intelligence. We offer enriched data, insights & analytics, workflow solutions and expert services in the areas of Academia & Government, Intellectual Property and Life Sciences & Healthcare. Our connected data, deep expert ...
Sr Director, Regulatory Affairs - Oklahoma City, United States - HireMinds
Description
Our cutting-edge, vaccine client is seeking aSr. Director, Regulatory Affairs
(REMOTE) to their growing team This role will be accountable for developing regulatory strategies for their vaccine candidates with an emphasis on European requirements for early and late-stage assets. This person will be a key regulatory leader who partners with internal and external stakeholders to achieve successful regulatory filings and approvals in Europe, US and international. Oursuccessful candidate will have significant regulatory experience in vaccine development with a focus on Europe and the US.
Responsibilities include but not limited to:
Implement the regulatory strategies for early and late-stage assets and actively contribute to the associated clinical development plans.
Provide critical regulatory input to cross functional internal teams, external CROs and consultants in the planning, organizing, and submission of regulatory dossiers to EMA, European NRAs and other global regulatory agencies.
Liaise with CROs to prepare clinical content of submissions in Latin America and Asia.
Track and evaluate changes to regulatory requirements and guidelines as they impact development of company assets.
Requirements:
Minimum of a bachelor's degree in a related Science Field; advanced degree in Science desirable AND7+years of regulatory experience in a pharmaceutical/biologics company with demonstrated increasing expertise and responsibility.
A working knowledge of US, EU and international regulatory and GxP standards relevant to the development and approval of new vaccines.
Extensive knowledge of clinical trial designs and global reporting requirements
Experience developing the clinical and labeling content and format for original and supplemental license applications.
Ability to work in a fast paced/flat/dynamic small company environment
Excellent influencing and negotiating experience and capabilities in a matrix environment
Able to handle multiple projects and exercise good judgment in prioritizing tasks.
Proficient with Microsoft Office and Veeva Vault applications, Adobe and document management templates.
Travel:
Location in Boston or Europe preferred; remote or hybrid options will be considered.
Willingness to travel (20-25%) to various meetings or client sites, including overnight trips and international travel.
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