Manager, Regulatory Affairs

3 weeks ago


Des Moines, United States Kindeva Drug Delivery Company Full time

Posted Friday, December 22, 2023 at 5:00 AM Kindeva 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

y 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.

#J-18808-Ljbffr



  • Des Moines, United States Palmer Group Full time

    An 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! Responsibilities: Develop and implement regulatory compliance strategies to ensure...


  • Des Moines, United States Alliant Energy Full time

    **Bring YOUR energy to Alliant Energy!** At Alliant Energy, our purpose is to serve customers and build stronger communities. We are passionate about powering beyond the market challenges of today, while powering what's next in energy. When our employees say "I am energy", it means they take pride in the work we do when disaster strikes, as well as all the...


  • Des Moines, United States EMC Insurance Full time

    At EMC, you'll put your skills to good use as an important member of our team. You can count on gaining valuable experience while contributing to the company's success. EMC strives to hire and retain the best people by engaging, developing and rewarding employees. Candidates who exceed the minimum qualifications posted, may be considered for a higher level...


  • Des Moines, Iowa, United States Department Of Veterans Affairs Full time

    Summary The Central Iowa VA is hiring for a RN assigned to Rehabilitation and Extended Care. Duties The VA Midwest Health Care Network advocates for a Whole Health System of care in each of the Medical Centers. This is an approach to healthcare that empowers and equips people to take charge of their health and well-being and live their lives to the...


  • Des Moines, United States Planned Parenthood Full time

    Planned Parenthood North Central States Iowa, Minnesota, Nebraska, North Dakota, South Dakota Public Affairs Summer Intern - Des Moines, IA Pay: $17 per hour Schedule: Part-time, 15 hours per week, varied. Shift times: The work schedule will vary depending on the week. It will be divided among tabling time, recruitment, and data entry. Location: Des...

  • Housekeeping Aid

    1 month ago


    Des Moines, United States Department Of Veterans Affairs Full time

    Summary This position is located within the Environmental Management Services Division of the Des Moines VA Medical Center. Incumbent performs both janitorial and custodial services (e.g., textile distribution and inventory activity, sanitizing and disinfecting, waste removal, cleaning of...

  • Housekeeping Aid

    1 month ago


    Des Moines, Iowa, United States Department Of Veterans Affairs Full time

    SummaryThis position is located within the Environmental Management Services Division of the Des Moines VA Medical Center. Incumbent performs both janitorial and custodial services (e.g., textile distribution and inventory activity, sanitizing and disinfecting, waste removal, cleaning of blinds, replacing curtains, washing windows and walls, dusting and...

  • Safety Manager

    2 days ago


    Des Moines, United States O'Reilly Auto Parts Full time

    Work with corporate safety team to ensure all DC, store, and fleet safety programs, along with regulatory compliance initiatives, are carried out. This role will participate in identifying trends and developing appropriate programs and tools to minimize loss and regulatory noncompliance exposure. Will have a heavy emphasis on on-site training. Will do so...


  • Des Plaines, United States Oakton Community College Full time

    Job DescriptionJob DescriptionOverview: Student employee needed to assist Executive Assistant to support day to day functions of the Office of Student Affairs. Support needed in the areas of greeting visitors, answering phones, copy and scanning documents. Student employee to be available to run errands and assist the Assistant Vice President and the Vice...


  • West Des Moines, United States American Equity Full time

    At American Equity Investment Life Holding Companywe offer leading annuity products that help empower our clients to fulfill their needs and wants in retirement. Our success comes from hiring high-energy individuals who embody the beliefs that drive our unique culture. We currently fund over half a million retirements nationwide, and have been headquartered...

  • Compliance Manager

    7 days ago


    Des Moines, United States Bankers Trust Company Full time

    The Compliance Manager supports the Bank's business units by implementing and overseeing a regulatory Compliance Management System (CMS) and Fair Banking program designed to achieve proactive compliance with applicable statutes, regulations, and guid Compliance Manager, Manager, Compliance, Monitoring, Business, Banking, Business Services

  • Branch Manager

    13 hours ago


    Des Moines, United States Airgas Full time

    R10043864 Branch Manager (Open) Location: Holt Summit, MO - Retail shop How will you CONTRIBUTE and GROW? If you are seeking a company that values its employees, encourages growth and development, and makes a global impact, Airgas is the place for you. Join our team and be a part of an organization that is shaping the future of the gas and welding industry...

  • Field Safety Manager

    3 weeks ago


    Des Moines, United States O'Reilly Auto Parts Full time

    Work with corporate safety team to ensure all DC, store, and fleet safety programs, along with regulatory compliance initiatives, are carried out. This role will participate in identifying trends and developing appropriate programs and tools to minim Safety Manager, Manager, Delivery Specialist, Field, Compliance Manager, Environmental, Automotive, Business...


  • Des Moines, United States Ameren Full time

    Manager, Financial Reporting page is loaded Manager, Financial Reporting Apply locations St. Louis, MO time type Full time posted on Posted 3 Days Ago job requisition id 029545 About Us Ameren is a leader in the energy industry, and our transformation toward more clean, renewable energy is also transforming other industries and infrastructure in our...


  • Des Moines, Iowa, United States DMU Full time

    At DMU you will make a meaningful contribution to the dynamic future of Medicine and Health Sciences. DMU is seeking a Director of Operations, Compliance, and Strategy. This role will work with the Executive Director of Research, the Research team, and the Faculty Leadership Team to plan and manage DMU's research enterprise. The Director will design and...

  • Maintenance Manager

    7 days ago


    Des Moines, United States Archer-Daniels-Midland Company - ADM Full time

    Maintenance Manager - Des Moines, IA Under the direction of the Plant Manager, the Maintenance Supervisor is the leader responsible for the safety, regulatory compliance, operation, colleague development and leadership, and performance of the Des Moi Maintenance Manager, Maintenance Supervisor, Manager, Plant Manager, Leadership, Maintenance, Manufacturing


  • Des Moines, United States Kemin Industries, Inc. Full time

    Overview 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 by this position is to evaluate industry trends and fully analyze Kemin's...


  • Des Moines, Iowa, United States Alzheimer's Association Full time

    The 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 forces and work groups; and is responsible for grassroots engagement and...


  • Des Moines, United States Ridedart Full time

    Position Summary: The Communications Manager will lead all internal and external communications. This position will create integrated communications programs in support of organizational goals, engaging a variety of distinctly different and important audiences. This position will lead a Communications Coordinator to ensure effective implementation of...


  • Des Moines, United States Bridgeway Search Group Full time

    What will the right person find attractive about the role? Based on their growth trajectory, opportunity to guide a $6 Billion Bank through their next phase of regulatory compliance as they move toward and pass the $10B threshold Hybrid Schedule What is the company looking for? Strong background in consumer lending compliance Supervisory experience Strong...