- Provide interpretation of regulatory authorities' feedback, policies and guidelines.
- Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation of major clinical submissions required for regulatory approval.
- Work with project teams to resolve complex project issues. Utilize regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure attainment of governmental approvals.
- Responsible for quality and timeliness of IND/CTA and BLA submissions. Interact with other functions and partners, in the preparation, review, and completion of documents for regulatory submissions.
- Successfully plan, prioritize, supervise and/or conduct activities in close collaboration with leads from other areas. Assure compliance with regulations and with project team timelines.
- Provide interpersonal support and lead personnel.
- Excellent verbal and written communication skills
- Critical thinking, leadership skills, assertiveness, excellent negotiation and project management skills as evidenced by past performance on drug development project teams
- Ability to thrive in a fast-paced, entrepreneurial environment with successful colleagues
- Ability to function at a high level in a team setting whether leading the group or acting individually
- If you bring good understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices.
- If you are interacting with CROs in the management of ex-US/ex-EU CTAs towards clinical trial activations preferred
- If you have a high attention to detail; ability to coordinate and prioritize assigned projects according to company goals
- You bring strong interpersonal skills both written and verbally
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ED, NPS Hematology Strategy
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Novartis AG East Hanover, United StatesSummary · The role of the ED, NPS [Hematology] is to serve as the leader for product and program strategy in support of patient access to achieve product and/or portfolio objectives in the hematology portfolio pipeline. This role owns ongoing planning, evaluation/measurement, and ...
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Bristol-Myers Squibb Summit, United StatesWorking with UsChallenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to ...
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Bristol Myers Squibb Princeton, United StatesWorking with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production lin ...
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Bristol-Myers Squibb Company Princeton, United States**Working with Us** · Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production ...
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Medical Director
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Bristol-Myers Squibb Princeton, United States**Working with Us** · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production ...
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Regeneron Pharmaceuticals, Inc Bernards, United States Full timeThe Associate Director, Clinical Scientist leads in the development, evaluation, planning and execution of hematology oncology clinical studies and ensures scientific integrity and interpretation of study data of a clinical development program. Leads in a matrix environment as pa ...
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BioSpace Basking Ridge, United StatesJob Details · Join a Legacy of Innovation 110 Years and Counting · Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our wo ...
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Daiichi Sankyo, Inc. Basking Ridge, United StatesJob Description · Join a Legacy of Innovation 110 Years and Counting · Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging ou ...
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Daiichi Sankyo Basking Ridge, United States Full timeJoin a Legacy of Innovation 110 Years and Counting · Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class scie ...
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Director, GMA Oncology
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Director, Regulatory Affairs Strategy, Hematology - Bernards, United States - Regeneron Pharmaceuticals, Inc
Description
The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so responsibilities will include support to some clinical study activities. The candidate will also supply, lead and/or supervise IND/CTA and BLA submissions activities.In this role, a typical day might include the following:
This role might be for you if:
To be considered, you must possess excellent written and verbal communication skills along with a MD, Ph.D. or Pharm D. degree. We expect a minimum of 10 years of pharmaceutical industry experience, at least 7 of which should include regulatory experience. We expect you to be onsite a couple days a week in either Basking Ridge, NJ, Armonk, NY or Tarrytown, NY.
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