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Lead Political Public Affairs Manager CIHBw
2 weeks ago
Bwi IT New York, United StatesAls IT-Systemhaus der Bundeswehr und IT-Dienstleister des Bundes bieten wir umfassende IT-Services aus einer Hand. Mit ber 7.000 Mitarbeiter*innen zhlen wir zu den zehn grten IT-Service-Providern Deutschlands. Wir suchen authentische IT-Liebhaber*innen, die ihre Leidenschaft mit ...
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Lead Political Public Affairs Manager CIHBw
2 weeks ago
Bwi IT New York, United StatesAls IT-Systemhaus der Bundeswehr und IT-Dienstleister des Bundes bieten wir umfassende IT-Services aus einer Hand. Mit über 7.000 Mitarbeiter*innen zählen wir zu den zehn größten IT-Service-Providern Deutschlands. Wir suchen authentische IT-Liebhaber*innen, die ihre Leidenschaft ...
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Corporate Affairs Lead Thailand
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PepsiCo New York, United StatesOverview: · Creates the most favorable business climate for PepsiCo Thailand and secure license to operate by owning, driving and enhancing all external and internal stakeholder management. · Sponsors and create programs and platforms that enhance reputation. · Leads the agend ...
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Lead Regulatory Affairs Associate
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Navitas Life Sciences New Jersey, United StatesJob Title: Lead Regulatory Affairs · Work Location: US – EST, CST time zone. · Reports To: Practice Head - Regulatory · Job Description: · Develop and manage day-to-day operations using project management and planning tools, create and maintain detailed project timelines · Est ...
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Global Medical Affairs TA Lead
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BioCT Innovation Commons Ridgefield, United StatesApplication Process · This position can be filled in the US (Ridgefield) or in Germany. · If you want to apply for the position in Germany, please use this link: · External ad: · https://jobs.boehringer- · Internal ad: · https://jobs.boehringer- · If you want to apply for the ...
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Daiichi Sankyo, Inc. New Jersey, United StatesJoin 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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Team Lead, International Regulatory Affairs
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Yoh Ridgefield, United StatesSite Monitoring Lead Clinical Trials Ridgefield, CT REMOTE (EST AND CST APPLICANTS ONLY) 24 month W2 contract (with potential to extend or transition to perm) About 25% travel Accountable for the execution of monitoring plans & overall quality of monitoring performed by CRAs for ...
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Daiichi Sankyo, Inc. New Jersey, United StatesJoin 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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argenx New York, United StatesThe Integrated Medical Affairs and Evidence Generation group delivers ambitious, patient-focused cross-regional and cross-indication medical strategies, driving data generation and dissemination, to maximize patient benefit from argenx products. · The Global Indication Lead will ...
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Argenx New York, United StatesThe Integrated Medical Affairs and Evidence Generation group delivers ambitious, patient-focused cross-regional and cross-indication medical strategies, driving data generation and dissemination, to maximize patient benefit from argenx products. · Are you ready to apply Make sur ...
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Sr Associate, Product Safety Specialist
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Nice-Pak Montvale, United StatesExcellence Wanted. · About Us. · Nice-Pak is more than just a Nice Place to Work, and we owe it to our amazing team of nice people to ensure we are hiring new team members who can do more than just meet expectations. We aim to hire excellence. · At Nice-Pak, we manufacture prod ...
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Associate Director of International Programs
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Mercy College Dobbs Ferry, United StatesJob Posting Summary · The Associate Director of International Programs will provide management and oversight for delivering new educational programs offered by the division to students outside the United States. The Associate Director will have primary responsibility for engaging ...
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Director, Regulatory Affairs Strategy
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NS Pharma, Inc. Paramus, United StatesResponsible for developing and implementing short and long term global regulatory strategies that support the success of investigational and marketed pharmaceutical products throughout their life cycle. The Director will manage and lead regulatory strategy and submission related ...
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AAAS Pearl River, United StatesWe have an exciting opportunity for a Director to join our vaccines Global Regulatory Science team as a US Regional Regulatory Strategist (RRS). This is an excellent opportunity to join a growing and dynamic team and be in charge of various projects. We are looking for candidates ...
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Director of the Foundation
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Bergen Community College Paramus, United States Full timeThe Director of the Bergen Community College Foundation provides strategic direction, management, and overall leadership for development efforts in support of Bergen Community College. The Director will work in consultation with and receive guidance from the Vice President of Ext ...
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Territorial Social Services Director
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West Nyack - THQ West Nyack, United States contract· Overview · The Salvation Army, an international movement, is an evangelical part of the universal Christian Church. Its message is based on the Bible. Its ministry is motivated by the love of God. Its mission is to preach the gospel of Jesus Christ and to meet human needs in H ...
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HR Representative
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ASR Group/Domino Sugar Yonkers, United StatesASR Group is the worlds largest refiner and marketer of cane sugar, with an annual production capacity of more than 6 million tons of sugar. The company produces a full line of grocery, industrial, food service and specialty sweetener products. Across North America, ASR Group own ...
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Senior Director, Consumer Marketing
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Regeneron Pharmaceuticals, Inc Tarrytown, United States Full timeKnown for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets medicines for eye d ...
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VP of Food Safety
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BrightFarms Inc Irvington, United StatesJob Description · Job DescriptionBrightFarms - The Pinnacle of Sustainable Indoor Farming · As industry leaders in sustainable indoor farming, BrightFarms is currently in the midst of an exciting expansion and national scaling. We are launching several new, climate-controlled gre ...
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Executive Director, HR Business Partner
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Regeneron Pharmaceuticals, Inc Tarrytown, United States Full timeThis Senior level HR Business Partner role will lead the HRBP team for all of Regeneron's Corporate Functions (G&A) which includes Finance, Law, Global Procurement, IT, Corporate Affairs, Investor Relations and Strategy / BD, etc.. It will provide strategic consultation to the se ...
Senior Director/Director, Global Regulatory Affairs Lead - Norwood, United States - Corbus Pharmaceuticals
1 day ago
Description
As a pivotal member of the Corbus Product Development Team(s) (PDT) supports Corbus' drug development by developing and overseeing the execution of regulatory strategy in the US/EU and other territories deemed applicable.
Qualifications and Experience:
Bachelor's Degree in life sciencesHigher degree preferred or equivalent experience10+ years' experience in biotech or pharma with 7+ years in Regulatory AffairsExperience in all types of regulatory submissions including but not limited to INDs, NDAs, MAA, Type A-D Meetings with FDA, Scientific Advice Consultations with the CHMP of EMA and MHRA, MAA.Experience with filing Orphan Drug Designations (ODD), FastTrack, Breakthrough Designations (BTD) and Priority Medicines Initiatives (PRIME) and other accelerated regulatory pathways ideal.
Ideally this role will be located in Norwood, Massachusetts as a hybrid role 3 days onsite weekly but flexible for remote candidates open to travel monthly to Norwood, Massachusetts.
Responsibilities:
Collaborate with the leadership team to develop Regulatory Strategy as part of an integrated development plan for each Corbus asset including inclusion/adoption of accelerated regulatory pathways where possible.
Leading working groups tasked with developing regulatory submissions e.g. IND working group.
Overseeing clinical trials submissions performed by Contract Research Organizations (CRO) ensure timely and good quality submissions supportive of the overallProviding regulatory input on safety documentation e.g.
Development Safety Update Report (DSUR), Investigator's Brochure (IBs)Providing regulatory input on clinical documentation as required e.g. Protocols, Clinical Study Reports (CSR)Reviewing external communications e.g.Publications, Press Releases, postings for regulatory complianceIdentifying and managing subject matter experts engaged to support regulatory activitiesEnsuring that Corbus has a complete record of all regulatory submissions made by the company or on behalf of the company.
Qualities:
Demonstrate a collaborative leadership style within the Product Development Team when providing regulatory expertise.
Prepared to be hands-on as well thinking strategically.
Communicate well with internal and external stakeholders.
Be able to effectively articulate to Senior Management regulatory risk and the potential impact.
Corbus Culture:
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 place to share ideas and grow. At Corbus, transformative ideas can come from anyone, anywhere and anytime. We offer our team flexibility and the opportunity to excel in their professional journey. We provide a welcoming space where collaboration, mentorship and diversity are encouraged. We come together, like no other, to elevate each other and focus on what's best for patients.
About Corbus:
Corbus is committed to leveraging our expertise in immunology to fulfill our purpose of developing innovative new medicines that improve the lives of people living with inflammatory, fibrotic, and metabolic diseases, and cancer.
Corbus' current pipeline includes small molecules that activate or inhibit the endocannabinoid system and anti-integrin monoclonal antibodies that block activation of TGFβ and an antibody drug conjugate targeting tumors expressing nectin-4.
Corbus is headquartered in Norwood, Massachusetts. For more information on Corbus,visit Connect with us on Twitter, LinkedIn and Facebook.Corbus Pharmaceuticals Holdings, Inc. is an equal opportunity employer.
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