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Associate Director, Regulatory Affairs - CMC. The Associate Director of regulatory Affairs will be responsible for the development and execution of the Regulatory strategy for assigned programs in alignment with the corporate goals.
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Additionally, the VP, Regulatory Affairs and Quality will be responsible for hiring a Director, Regulatory Operations, to report to them. The Vice-President, Regulatory Affairs and Quality will work collaboratively with colleagues across the company, and with outside partners, to design and execute global registrations strategies for all Xilio products, including initial regulatory efforts on pipeline programs.
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Practical experience in the pharmaceutical or biotech industry of at least five years in at least one major area of drug development, such as Discovery, Preclinical Development, Clinical Development, or Regulatory Affairs.
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Cross-functional clinical processes, including data management, biostatistics, medical writing, drug safety/pharmacovigilance, and regulatory affairs. Negotiates cross-functionally, successfully motivates and influences (Clinical Development, Regulatory Affairs, CMC, QA, Pharmacovigilance, etc.
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Work cooperatively with representatives of all PSI departments, including but not limited to facilities, property management, development and external affairs, finance, and human resources. Investigate and follow-up tenant grievances in partnership with the Case Management Supervisor.
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8+ years of regulatory affairs experience in drug development and product registration activities within the pharmaceutical or biotech industry in multiple phases of development; both big and small company experience is preferred.
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Serving as a field-based extension of Medical Affairs, the Medical Science Liaison (MSL) will represent the Company, a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies that target p53 mutations.
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Cross-functional Collaboration: Work closely with R&D, marketing, sales, regulatory affairs, and other departments to provide proactive legal support and ensure that specialty care initiatives and strategies are legally sound and compliant with internal and external requirements.
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Responsible for clinical trial transparency and disclosures, including clinical trials results posting on clinicaltrials.gov, EudraCT, and similar databases worldwide, in collaboration with Regulatory Affairs.
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The company has a really strong portfolio in dermatology and rheumatology and requires and experienced Medical Affairs leader to plan for the launch of important new medicines. A large pharma business has a new role to lead its Medical Affairs function in its Immunology franchise.
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BA/BS in Education, Business, Management, Public Affairs, International Affairs/International Relations, Social Work. BA/BS in Education, Business, Management, Public Affairs, International Affairs/International Relations, Social Work.
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Partner with Corporate Communications, Advocacy and Government Affairs strategy as it pertains to the global market access environments. This role collaborates cross-functionally with key cross-functional partners including other GMA functions, Clinical Development/Operations, Regulatory Affairs, Corporate Communications/IR, Legal, Market Access and Commercial, and Research.
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Compliance & Risk Management Director
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Collaborate with CMC, Program & Portfolio Management, Clinical, and Regulatory Affairs to develop program-specific strategies for appropriate data generation in support of development candidate nomination, IND filing, and clinical development of new small molecule drug entities.
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POSITION SUMMARY: Under the direction and guidance of the Associate Vice President, Career and Digital Strategy, the Senior Director of Industry and Employer Engagement will develop and lead the implementation of a comprehensive strategic plan that drives engagement with industry, including employers, recruiters and alumni in coordination with Academic Affairs, the International Career Center (ICC) and Alumni Affairs.
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affairs job in Waltham, MA
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