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Silence Therapeutics plc
Hoboken, NJ, United States
Lead US Regulatory Affairs Strategy Function in support of our lead development programs, joint- venture development programs, and other programs delegated by the SVP (SLN 360, SLN 124, SLN 501, SLN 140). Key Responsibilities The Director of US Regulatory Affairs will provide strategic leadership on all regulatory activities. Responsibilities wil
Job Source: Silence Therapeutics plcMitsubishi Tanabe Pharma
Jersey City, NJ, United States
Actively leads development and implementation of regulatory strategies for assigned programs and ensures cross-functional alignment. Leads regulatory activities within the project teams (nonclinical, clinical) to assure timelines and milestones. With Regulatory Affairs, Clinical, Director, Regulatory, Clinic, Product Development, Business Services
Job Source: Mitsubishi Tanabe PharmaAttaineo Search, Inc.
New York, NY, United States
Job Description Position: Director, Regulatory Affairs Strategy Location: New York City, NY (Remote) Overview: The Director of Regulatory Affairs Strategy will take a lead role in crafting and executing global and regional regulatory strategies for a range of projects and products. The incumbent will collaborate with various internal teams, ma
Job Source: Attaineo Search, Inc.Mitsubishi Tanabe Pharma
Jersey City, NJ, United States
Overview 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 Japan’s most respected - is a research-driven pharmaceutical company that
Job Source: Mitsubishi Tanabe PharmaBiocodex
Jersey City, NJ, United States
Biocodex is a French family-owned pharmaceutical company headquartered in Gentilly, near Paris, France. The company was founded in 1953 to develop and market the world's first probiotic yeast strain, Saccharomyces boulardii CNCM I-745, discovered in 1923. Building on relationships established for nearly 70 years with healthcare professionals, the
Job Source: BiocodexMitsubishi Chemical Group
Jersey City
**Overview** **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 Japan’s most respected - is a research-driven pharmaceutical compan
Job Source: Mitsubishi Chemical GroupCLevelCrossing
Jersey City, NJ, United States
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis. Join us and make a difference. We hire the best people and provide them with
Job Source: CLevelCrossingMitsubishi Chemical Group
Jersey City, NJ, United States
Overview 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 Japan’s most respected - is a research-driven pharmaceutical company that
Job Source: Mitsubishi Chemical Group, ID, United States
T he Role:
The Agenus Regulatory team is seeking a motivated, resourceful, and collaborative team member to join the team. This candidate should be able to work cross-functionally, and complete assigned tasks independently with guidance from the Global Head, Regulatory to ensure Agenus adheres to global regulations.
The Director of Regulatory Affairs will develop and implement regulatory strategies for all assets in all stages including IND, NDA, and Lice Cycle Management activities across the Agenus portfolio. Reporting to the Global Head of Regulatory, the candidate must have the ability to work independently and as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential.
In the role you will:
Develop and implements regulatory strategies and contingencies for global product development (investigational, licensing/registration, and post-marketing support).
Participate in team meetings to provide regulatory support and guidance.
Provide guidance and expertise to senior management and other departments on all regulatory issues for the strategic development, planning, compilation and submission for all regulatory filings.
Provide timely and effective communication updates on regulatory interactions to senior management and other internal stakeholders, as appropriate.
Serve as the primary contact and liaise, negotiate and orchestrate with Health Authorities.
Lead key health authority meetings, as needed, that could impact global product strategy.
Edit or lead the editing of regulatory documentation based upon regulatory requirements and Company SOPs.
Ensure compliance with existing regulatory applications (e.g. IND/CTA Maintenance).
Assist with the preparation, writing and review of regulatory documents.
Oversee late-stage development applications and marketing approved product applications.
Work with partner company counterparts to support pharma partner requirements.
Provide support on labeling and advertising matters.
Interface with contractors, vendors and consultants.
Maintain knowledge of regulatory environment, global regulations and guidance.
Contribute to the development and maintenance of Regulatory Affairs working practices and procedures.
Qualifications: About You:
BA/BS undergraduate degree in life sciences. MS, PhD or other relevant advanced degree preferred.
10 years of drug development experience inclusive of a minimum of 5 years in regulatory affairs with roles increasing in scope
Strong knowledge of worldwide drug development and regulatory policy; demonstrated excellent judgement in Regulatory-focused drug development.
Demonstrated ability to interpret and understand US regulations governing pharmaceutical industry.
Comprehensive understanding of drug development and related concepts, such as clinical trial design, statistics, and clinical pharmacology.
Strong written, verbal, and interpersonal communication skills, with the ability to effectively interact with individuals at all levels across organization.
Prior experience with FDA and EMA submissions required.
Ability to critically review regulatory scientific documents across non-clinical and clinical
Ability to constructively challenge, question, and provide creative suggestions for regulatory trial processes in order to create the most efficient and effective methods to deliver quality clinical trial services.
Naturally connects and builds strong relationships with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively.
Strong leadership skills in leading team members and vendors.
Strong organizational, communication and interpersonal skills
Ability to prioritize, delegate and execute to meet project deadlines.
At ease in start-up environment and effectiveness to deliver in low-structured environments.
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Email Alert for Director, Regulatory Affairs jobs in , ID, United States
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