Associate Director, CMC Regulatory Affairs
4 days ago
MannKind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies - dry-powder formulations and inhalation devices - offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication.
Position Summary: MannKind Corporation has an opening for an Associate Director, CMC Regulatory Affairs in Danbury, CT.
DUTIES: Lead and compile global regulatory submissions using eCTD. Oversee the preparation of responses to deficiency comments/letters from health authorities and provide input and guidance on interpretation of deficiency comments and guide the formulation of responses. Assist with development of documents submitted to health authorities and related to expedited regulatory programs, meeting requests, meeting background packages, and other regulatory documents of this nature. Author internal regulatory documents, such as Regulatory Assessments and Strategy documents. Review internal change controls and assess impact to regulatory filings.
MINIMUM REQUIREMENTS: Pharm.D or Ph.D. Degree in Regulatory Affairs, Life Sciences, or a related field, or the foreign equivalent. 5 years of experience in offered position or related role. At least 5 years of experience working with analysis and interpretation of complex problems and data in regulatory affairs domain. At least 5 years of experience working with global (U.S., LATAM, EMEA, and APAC) regulatory guidelines and other regulations/requirements. At least 5 years of experience working with small molecule/biologics.
-
Associate Director, CMC Regulatory Affairs
5 days ago
Danbury, Connecticut, United States MannKind Corporation Full timePosition: Associate Director, CMC Regulatory AffairsLocation: Danbury, CTJob Id: 11217# of Openings: 1MannKindMannKind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using...
-
Associate Director, CMC Regulatory Affairs
5 days ago
Danbury, Connecticut, United States MannKind Corp. Full timeMannKind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes,...
-
Associate Director, CMC Regulatory Affairs
22 hours ago
Danbury, Connecticut, United States MannKind Full timeMannKind MannKind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as...
-
Danbury, Connecticut, United States Canopy Life Sciences LLC Full timeAt Canopy Life Sciences, we are leading the way in advancing healthcare through innovation, collaboration, and a steadfast commitment to excellence. Our Regulatory Affairs division is made up of dedicated professionals who thrive in a dynamic, fast-paced environment, and we are seeking like-minded individuals to join our growing team.Associate...
-
Regulatory Affairs Strategy Lead
5 days ago
Danbury, Connecticut, United States Canopy Life Sciences LLC Full timeAt Canopy Life Sciences, we are a leader in advancing healthcare through innovation and collaboration.Job DescriptionWe are seeking a highly motivated and detail-oriented Associate Director/Director, Regulatory Affairs (Strategy) to join our growing team. This role will be primarily responsible for assisting pharmaceutical and biotechnology company clients...
-
Associate Director Regulatory Services
5 days ago
Danbury, Connecticut, United States Canopy Life Sciences LLC Full timeOur Regulatory Affairs team at Canopy Life Sciences is dedicated to supporting pharmaceutical and biotechnology company clients in developing and implementing regulatory strategies to advance their products through clinical development and commercialization. To help us achieve this goal, we are seeking a highly experienced Associate Director/Director,...
-
Director of Regulatory Compliance
5 days ago
Danbury, Connecticut, United States Canopy Life Sciences LLC Full timeWe are expanding our Regulatory Affairs team at Canopy Life Sciences LLC and are seeking a highly experienced professional to fill the position of Associate Director/Director, Regulatory Affairs (Strategy). As a key member of our team, you will be responsible for developing and implementing regulatory strategies to support the advancement of pharmaceutical...
-
Danbury, Connecticut, United States Canopy Life Sciences LLC Full timeJob Description Job Description At Canopy Life Sciences, we are leading the way in advancing healthcare through innovation, collaboration, and a steadfast commitment to excellence. Our Regulatory Affairs division is made up of dedicated professionals who thrive in a dynamic, fast-paced environment, and we are seeking like-minded individuals to join our...
-
Senior Regulatory Strategist
5 days ago
Danbury, Connecticut, United States Canopy Life Sciences LLC Full timeCanopy Life Sciences is a dynamic company that specializes in advancing healthcare through innovation and collaboration. We are currently seeking a skilled Associate Director/Director, Regulatory Affairs (Strategy) to join our Regulatory Affairs team. In this role, you will play a critical part in helping pharmaceutical and biotechnology company clients...
-
Regulatory Affairs Expert
7 days ago
Danbury, Connecticut, United States BioCT Innovation Commons Full timeJob DescriptionThe Senior Legal Advisor for Life Sciences provides a broad range of legal services to support the pharmaceutical industry. This role requires expertise in regulatory affairs, including experience working on FDA prescription drug regulatory matters and familiarity with the federal Anti-Kickback Statue and False Claims Act.This position will be...
-
Regulatory Affairs Coordinator
2 days ago
Danbury, Connecticut, United States MannKind Full timePosition Description:MannKind Corporation is seeking a highly skilled Regulatory Affairs Coordinator to join our team in Danbury, CT. As a key member of our quality assurance department, you will be responsible for ensuring that processes and products conform to established company and regulatory standards.Your primary focus will be on reviewing, analyzing,...
-
Associate Director, Patient Marketing
4 weeks ago
Danbury, Connecticut, United States MannKind Full timePosition: Associate Director, Patient Marketing (Consumer)Location:Danbury, CTJob Id: 111173# of Openings: 1MannKind MannKind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed...
-
Associate Director, Patient Marketing
4 weeks ago
Danbury, Connecticut, United States MannKind Full timeMannKind MannKind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as...
-
Associate Director
9 hours ago
Danbury, Connecticut, United States BioCT Innovation Commons Full timeThe Senior Associate Director (SAD), Stakeholder Relations will serve as a functional lead and primary point of contact for US headquarters based (BIPI) top customer engagement interactions with Early Asset (EA) and Asset team key external experts (KEE) and Professional Medical Associations (PMA). As an internal lead for coordinating EA & Asset team...
-
Danbury, Connecticut, United States BioCT Innovation Commons Full timeThe Director & Sr. Counsel provides a broad range of legal services, typically to Clients at the VP level who control business activities and below. Level of counseling provided requires broader understanding of the impact decisions may have on the overall business, as the risks associated with incomplete advice are high. You will play a pivotal role...
-
Head of Corporate Affairs
20 hours ago
Danbury, Connecticut, United States BOC Canada Limited Full timeKey Responsibilities The Associate Director, External Communications will be responsible for managing communication strategies for company-wide issues, supporting our businesses as needed, and working with cross-function teams to mitigate reputational damage. You will also help monitor media and social media coverage of our company, competitors, industry,...
-
Associate Director of Workforce Development
3 weeks ago
Danbury, Connecticut, United States Western Connecticut State University Full timeWestern Connecticut State University is pleased to announce that applications are being accepted for an Associate Director of Workforce Development & Applied Learning in our Career Success Center. Western Connecticut State University (WCSU) is committed to enhancing our diverse university community by actively encouraging people with disabilities, members of...
-
Pharmaceutical Law Specialist
6 days ago
Danbury, Connecticut, United States BioCT Innovation Commons Full timeKey ResponsibilitiesCounsel clients on regulatory compliance and risk managementDevelop and implement effective regulatory strategies to drive business growthCollaborate with cross-functional teams to ensure alignment and consistency across the organizationMentor and train junior attorneys and staff members within the departmentStay up-to-date with evolving...
-
Life Science Counselor
6 days ago
Danbury, Connecticut, United States BioCT Innovation Commons Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Expert to join our team as a Senior Legal Advisor for Life Sciences. In this role, you will provide strategic guidance on complex regulatory matters and work closely with cross-functional teams to drive business growth.Your primary focus will be on ensuring compliance with applicable laws and...
-
Director of Geriatric Medicine
6 days ago
Danbury, Connecticut, United States The MedElite Group Full timeWe are seeking a dynamic and compassionate Medical Director to join our team at Infinite Medical P.C.Main Responsibilities:Oversight, mentorship, and clinical guidance to the medical staff.Leadership, guidance, and direction to clinical staff.Interview and credentialing process for prospective medical staff.Quality Assurance and Performance Improvement...