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Senior Manager Regulatory Affairs
1 week ago
Palmer Group Des Moines, United StatesAn industry leader in the nutritional and health sciences field is searching for a qualified candidate to hire for a · Senior Manager, Regulatory Affairs · position. If you are interested in the following responsibilities and meet the position requirements, please apply today ...
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Senior Manager Regulatory Affairs
1 week ago
Palmer Group Des Moines, United States3 hours ago · Be among the first 25 applicants · This range is provided by Palmer Group. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. · Base pay range · $110,000.00/yr - $130,000.00/yr · An industry leader in the nutritio ...
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The International Society for Pharmaceutical Engineering Inc Des Moines, United States**Description** · As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering v ...
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The International Society for Pharmaceutical Engineering Inc Des Moines, United States**Description** · **This is a hybrid position that requires onsite work 2-3 days a week, based on the team requirements. Remote work/high travel is not an option. Employees must be within a commutable distance of the job location. Relocation packages are available to qualified h ...
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Senior Manager, Regulatory Affairs
2 weeks ago
Lauridsen Group, Inc. Ankeny, United StatesThe Senior Manager of Regulatory Affairs plays a crucial role in ensuring Proliant Health & Biologicals (PHB) products comply with local and international regulations within our three key markets- diagnostics, therapeutics, and nutrition. This role involves working closely with r ...
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Senior Manager, Regulatory Affairs
2 weeks ago
LGI foundation Ankeny, United StatesSenior Manager, Regulatory Affairs - Proliant Health & Biologicals page is loaded · Senior Manager, Regulatory Affairs - Proliant Health & Biologicals · Apply · locations · Ankeny, Iowa · time type · Full time · posted on · Posted 30+ Days Ago · job requisition id · R27 ...
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Takeda Pharmaceuticals Des Moines, United StatesTakeda Pharmaceuticals · Associate Director, Global Regulatory Project Management and Strategic Planning - Neuroscience · Des Moines , · Iowa · Apply Now · By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that ...
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Medical Science Liaison
1 week ago
Sanofi Group Des Moines, United States**US Medical Science Liaison, Immunology - Non-Alliance - (GI) - (N. CA, NV)** · **ABOUT THE JOB** · **Our Team:** · This position will report into the US Medical Immunology team which is a segment of the Medical Affairs Specialty Care organization. · Our Medical Affairs function ...
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Utility Manager
3 weeks ago
Dsjglobal Des Moines, United StatesWe are seeking a highly skilled and experienced Utility Manager to oversee the operation and maintenance of utility systems, with a specialized focus on large boiler systems, within our pharmaceutical manufacturing facility. The Utility Manager will play a crucial role in ensurin ...
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Sanofi Group Des Moines, IA, United States**Position Overview:** · The Mission of Sanofi's MSL Team and the Medical Science Liaison is to be the trusted scientific partners in the field for external experts and decision-makers engaging in mutual scientific exchanges to accelerate data dissemination. Sanofi's Medical Fiel ...
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Senior Clinical Research Monitor, Midwest
5 days ago
Edwards Lifesciences Des Moines, United StatesImagine how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientif ...
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Senior Technical Services Manager
1 week ago
Kemin Industries, Inc. Des Moines, United StatesOverview · Kemin Animal Nutrition & Health is seeking a Senior Technical Services Manager to join their Broiler team · In this role, this person will be responsible for providing technical support for the full commercialization of new technologies and products. Analysis required ...
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Executive Director, Commercial Supply Chain
2 days ago
Sumitomo Pharma Des Moines, United StatesSumitomo Pharma · Executive Director, Commercial Supply Chain · Des Moines , · Iowa · Apply Now · Executive Director, Commercial Supply Chain · Sumitomo Pharma America (SMPA) is focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need ...
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Director Marketing
2 weeks ago
Curium Pharma Des Moines, United StatesPress Tab to Move to Skip to Content Link · Curium is the world's largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven herita ...
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Technical Services Associate
2 weeks ago
Kemin Des Moines, United StatesOverview: · Kemin Health is hiring for a Technical Services Associate to join their team at our Headquarters location in Des Moines, Iowa The Technical Services Associate will be responsible for providing research, technical support, and sales assistance, to assigned current, po ...
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Director, Quality
2 days ago
Bausch & Lomb Des Moines, United StatesSelect how often (in days) to receive an alert: · Location: · US-MO-Saint Louis Kirkwood, Missouri, US · Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world—from the ...
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Technical Services Associate
1 week ago
Kemin Industries Des Moines, United StatesOverview · Kemin Health is hiring for a Technical Services Associate to join their team at our Headquarters location in Des Moines, Iowa The Technical Services Associate will be responsible for providing research, technical support, and sales assistance, to assigned current, pote ...
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Technical Services Associate
7 hours ago
Kemin Industries Des Moines, United StatesOverview · Kemin Health is hiring for a Technical Services Associate to join their team at our Headquarters location in Des Moines, Iowa The Technical Services Associate will be responsible for providing research, technical support, and sales assistance, to assigned current, pote ...
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Director Public Policy
2 weeks ago
Alzheimer's Association West Des Moines, United StatesThe Director of Public Policy serves as the principal staff for state government affairs and chief lobbyist in Iowa, representing the Alzheimer's Association before Iowa's legislature, governor, relevant state agencies, community stakeholders and coalitions, and on statewide task ...
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Director Biostatistics
1 week ago
Curium Pharma Des Moines, United StatesPress Tab to Move to Skip to Content Link · Curium is the worlds largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven herita ...
Manager, Regulatory Affairs - Des Moines, United States - Kindeva Drug Delivery Company
Description
Posted Friday, December 22, 2023 at 5:00 AMKindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies.
We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture many more tomorrows.Ready to work with purpose? Look no further, we are hiring for a Manager, Regulatory Affairs at our St. Louis Site
Role Summar
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Experienced CMC professional serving as project leader responsible for the development of initial CMC regulatory strategies, submissions and compliance activities for development programs and commercial products supporting the Business Unit little to no supervision.
This individual will provide and drive strategic and operational global CMC regulatory direction and documentation for assigned projects/products covering initial registrations and approval/post approval activities.
Leads the initial preparation of CMC information for submission to global regulatory agencies, generates and drives CMC strategies, assesses risks and develops contingency/mitigation plans.
Acts as the global CMC representative within cross-functional project teams, involving the interpretation of regulations and guidelines and the assessment of global implications for strategic CMC decisions with little to no supervision.
Accountable for assigned CMC programs, managing daily delivery of regulatory and strategic activities, including post-approval changes, portfolio growth initiatives, and ongoing compliance of commercial products in the portfolio.
May represent CMC during interactions with regulatory agencies and external partners either directly or in conjunction with Regulatory Affairs.Qualifications
The colleague will have BS/MS/PhD or equivalent scientific/engineering/pharmaceutical development sciences degree.
Must have a minimum of 5-7 years relevant pharmaceutical development, QA/QC, and/or manufacturing experience.
Must have a minimum of 4 years drug substance or drug product development or manufacturing technical support experience.
Experience with diverse dosage forms, particularly sterile combination products, is desirable.
Experienced in regulatory CMC professional or an individual with regulatory expertise in pharmaceutical science development or manufacturing and/or specific regulatory domain.
Ability to interpret and apply global / regional CMC regulatory policies and requirements for assigned portfolio.Sound understanding and functional knowledge of manufacturing / pharmaceutical sciences / the pharmaceutical industry with a clear understanding of drug development/commercial manufacturing of pharmaceutical products, including technical and scientific understanding of pharmaceutical drug development with technical writing skills.
Competent working knowledge of computer based systems such as Microsoft Office, controlled documentation systems (e.g. Documentum).Ability to learn and navigate tracking/change control systems, compliant and consistent use of systems (including GMP validated systems) and willingness to train and support others in system use.
Clear track record of effective teamwork, collaboration, and communication, and also demonstrated leadership ability in a cross-functional matrix team environment.
Product management along with planning/organizing by prioritizing and planning work activities and change agility are also essential attributes.Safety for our employees and our communities is a key priority for Kindeva Drug Delivery. Kindeva encourages everyone who can get vaccinated to get vaccinated.
Our Covid-19 task force monitors the external environment and will continue to evaluate our policies and procedures.
Equal Opportunity Employer:
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
