- Manage day-to-day operations using project management and planning tools
- Provide regulatory advice on development issues and communicate with stakeholders
- Review client programs and develop strategic plans for development
- Ensure compliance with regulatory requirements
- Author applications for submission
- Collaborate on SOP's, work instructions and workflows
- Author regulatory documents with oversight for submissions
- Work closely with development team on regulatory strategies
- Act as the regulatory liaison
- Help strategize EU expansion roadmap
- Support project management activities and manage relationships with stakeholders
- Knowledge in submissions for US Markets
- Experience in handling Oncology Products
- Knowledge of global submission standards and regulatory change management
- Understanding of regulatory information management concepts
- Excellent communication, interpersonal, presentation, and persuasive skills
- Self-driven with minimal supervision required
- Knowledge of technology in Regulatory domains
- Experience in eCTD Publishing systems and related tools
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Horizon Media, Inc. New York, United StatesJob Description · Job Summary · The Associate Counsel assists the Business and Legal Affairs ("BALA") team in the formal review and negotiation of standard BALA contracts, such as master service agreements, statements of work, sponsorship agreements, media purchase agreements, so ...
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Associate Director, Medical Affairs
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Mitsubishi Chemical Group 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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Touro University New York New York, United StatesOverview: · The Assistant/Associate Dean for Student Affairs and Administration serves as the Chief Student Services Officer for Touro College of Pharmacy (TCOP), reporting to the TCOP Dean. This entails oversight of all customer facing positions, such as student services, menta ...
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Axsome Therapeutics, Inc. New York, United StatesAxsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders. The Axsome team is a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disor ...
Lead Regulatory Affairs Associate - New Jersey, United States - Navitas Life Sciences
Description
Job Title: Lead Regulatory Affairs
Work Location: US – EST, CST time zone
Reports To: Practice Head - Regulatory
Job Description:
Qualifications: Graduate/Post-Graduate in life sciences
Required Knowledge and Skills:
Experience: Approx. 10 years in pharma/consulting companies in Regulatory domain