Regulatory Affairs Manager jobs in Iowa

Regulatory Affairs Manager manages regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Implements processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Manager utilizes established monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Manager investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Regulatory Affairs Manager typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)

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Senior Manager, Regulatory Affairs - Proliant Health & Biologicals
  • Proliant Health & Biologicals
  • Ankeny, IA FULL_TIME
  • The 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 regulatory agencies, cross-functional teams, and stakeholders to develop and implement regulatory strategies. The Senior Manager of Regulatory Affairs is responsible for leading and managing regulatory activities to ensure compliance with applicable global regulations and standards. This role involves developing and implementing regulatory strategies, collaborating with internal teams, and interacting with regulatory agencies. JOB QUALIFICATIONS: The ideal candidate will have prior experience in pharmaceuticals, human nutrition, medical device or diagnostic industries as well as experience working with major regulatory and government agencies including USDA, APHIS and FDA and possesses strong people development and decision-making skills. Education: Bachelor’s degree required in relevant discipline required. Master’s degree preferably in human nutrition, biochemistry, or comparable discipline strongly preferred. Experience: Minimum of 6 years’ regulatory experience in food, pharmaceutical industry, or medical device industry of increasing responsibility required. Experience with CMC and CDER requirements preferred. Background in the quality discipline is a plus. SKILLS: Professional conduct with high attention to detail. Strong verbal and written communication skills. Ability to work collaboratively and coordinate with team members. Competence in multitasking and organizational methods. Self-starter, strategic thinker with demonstrated strong analytical skills with proven ability to follow logical progression of thought. Proficient in MS Office, eQMS such as (Reliance) or similar, MS Teams. Interpret and communicate complex government rules & regulations. Excellent verbal and interpersonal communication skills; ability to present ideas effectively to all levels of management. Excellent organizational and time management skills, demonstrated prioritizing, planning and project management skills. Willingness to travel internationally and domestically as required. Extended work hours as necessary KEY RESPONSIBILITIES Strategic Liaison: Serve as the primary liaison for PHB Regulatory Affairs, aligning strategies with Quality Assurance, Corporate, Sales, and Operations. Regulatory Leadership: Develop and lead regulatory strategies and ensure alignment with overarching PHB business strategies. Provide regulatory leadership with expertise in CMC and CDER requirements. Manage interactions with health authorities, including meetings and communications. Submission Management: Develop and manage systems for high-quality submissions to regulatory health authorities. Coordinate regulatory document collection and inspection and audit needs for product and facility registrations. Monitoring and Communication: Monitor changes in the regulatory environment and communicate their impact internally. Support international market access for US and New Zealand products. Compliance and Quality Systems: Maintain Quality Systems knowledge to support Regulatory Affairs and Quality Assurance for compliance and continuous improvement. Handle import/export permits and renewals, supporting Customer Service and Sales with related issues. Collaboration and Coordination: Collaborate with various regulatory bodies such as USDA/APHIS, FDA, EMA, CFIA. Collaborate with LGI regulatory affairs for best practice implementation. Stakeholder Engagement: Influence and educate stakeholders on regulatory policy decisions. Lead cross-functional teams for problem-solving and project execution. Documentation and Training: Organize and electronically file documents supporting regulatory submissions and facility registrations/renewals per QMS and document management policies. Keep updated with regulatory developments through webinars, classes, and workshops. All other duties as assigned. LGI’s foundation began in 1916 as the Lauridsen Creamery, selling butter, eggs and poultry to the local community. Although our headquarters in Ankeny, Iowa, is not far from the old creamery in Dedham, Iowa, the company is now worldwide with more than fifty manufacturing and sales locations in twenty countries and sales in more than sixty countries. Each company under the LGI umbrella is truly independent. They have the ability and the charge to be entrepreneurial, to seek out new markets, to develop new products and applications, and – above all - to discover new ways to add value through fractionation and novel application. What’s more, because some LGI companies have offices and presence around the world, all LGI companies benefit from their exposure to new markets, new products, new applications and new thinking.
  • 13 Days Ago

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Senior Regulatory Affairs Associate
  • Actalent
  • Des Moines, IA OTHER
  • Description:Oversee regulatory support and compliance in accordance with guidelines from USDA, FDA, and international regulatory agencies. Responsibilities will be related to new product development a...
  • 1 Day Ago

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Director, Regulatory Affairs
  • Dexian
  • Ankeny, IA FULL_TIME
  • Job Summary:Dexian is seeking a Director, Regulatory Affairs for an opportunity with a client located in Ankeny, IA. Responsibilities:Develop and execute regulatory strategies and policiesCollaborate ...
  • 8 Days Ago

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SVP, Regulatory and Government Affairs
  • BHE Career Site
  • Des Moines, IA FULL_TIME
  • The SVP, Regulatory and Government Affairs is responsible for leading all legislative and regulatory developments that could impact BHE Renewables. This individual will lead the process to advocate fo...
  • Just Posted

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Director, Regulatory Affairs
  • Dexian Signature Consultants
  • Ankeny, IA FULL_TIME
  • Job DetailsJob Summary:Dexian is seeking a Director, Regulatory Affairs for an opportunity with a client located in Ankeny, IA. Responsibilities:Develop and execute regulatory strategies and policiesC...
  • 10 Days Ago

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Regional Quality and Regulatory Affairs Director EME
  • bioMérieux
  • Marcy, IA FULL_TIME
  • A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For 60 years and across the world, we have imagined and developed innovative diagnostics sol...
  • 11 Days Ago

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Regulatory Affairs Manager
  • Catalyst Life Sciences
  • Chicago, IL
  • Opportunity to join a global diagnostics company at their HQ just outside of Chicago, focused on the strategy for existi...
  • 6/10/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Blueroot Health™
  • PURPOSE STATEMENT: This position will be responsible for managing and coordinating implementation of regulatory requirem...
  • 6/10/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Lumicity
  • This opportunity is with a company revolutionizing the medical device industry with its cutting-edge technologies and co...
  • 6/9/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Tandym Group
  • Stamford, CT
  • Top hospital in Fairfield county, CT, just over the border from Westchester county NY, is seeking an experienced Regulat...
  • 6/8/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Mastech Digital
  • Oakland, CA
  • Position: HIM Director-Regulatory Affairs Manager Location: Oakland CA USA 94612 (5 days onsite) Duration: 12+ Months (P...
  • 6/7/2024 12:00:00 AM

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Regulatory Affairs Manager
  • SS White Dental
  • Lakewood, NJ
  • SS White Dental is seeking a Senior Regulatory Affairs Manager to support our Regulatory team. Candidates should have a ...
  • 6/7/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Dental Technologies Inc
  • Lincolnwood, IL
  • Job Description Job Description Job Title: Regulatory Affairs Manager Department: Quality Assurance Reports To: Vice Pre...
  • 6/6/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Procter & Gamble
  • Reading, England
  • Job Location Reading Job Description P&G is a leading global consumer goods company whose winning brands are Procter & G...
  • 5/22/2024 12:00:00 AM

Iowa (/ˈaɪəwə/ (listen)) is a state in the Midwestern United States, bordered by the Mississippi River to the east and the Missouri River and Big Sioux River to the west. It is bordered by six states; Wisconsin to the northeast, Illinois to the east, Missouri to the south, Nebraska to the west, South Dakota to the northwest and Minnesota to the north. In colonial times, Iowa was a part of French Louisiana and Spanish Louisiana; its state flag is patterned after the flag of France. After the Louisiana Purchase, people laid the foundation for an agriculture-based economy in the heart of the Corn...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Manager jobs
$132,514 to $186,912

Regulatory Affairs Manager in Wichita Falls, TX
Other names for this job might include Clinical Trials Systems Administrator, Global Regulatory Affairs Manager, Regulatory Administrator, Regulatory Affairs Director, Regulatory Affairs Manager, Regulatory Affairs Portfolio Leader, Regulatory Consultant, Regulatory Leader, Regulatory Process Manager, Regulatory Product Manager.
January 17, 2020
Regulatory Affairs Manager in Baltimore, MD
Lead strategic contributions and initiatives to develop regulatory services and improve current processes and procedures.
January 18, 2020
Regulatory Affairs Manager in Fort Lauderdale, FL
Regulatory Domain Support for business development, including solutioning and developing innovative solutions, creation of materials for and participation in sales pursuits, key client meetings, bid defences for RFIs and RFPs.
December 04, 2019