Current jobs related to Director, Code and Regulatory Affairs - Oak Park Heights - Renewal by Andersen


  • Florham Park, New Jersey, United States Planet Pharma Full time

    Job Title: Associate Director, Regulatory Affairs - GDP ContractorFlorham Park, NJ - Onsite 2-3x a week1-year contract with potential to extendJob Summary:The Associate Director, Regulatory Affairs - GDP Contractor, plays a pivotal role in overseeing regulatory activities related to antiviral initiatives on a regional and/or global scale. This role involves...


  • Florham Park, New Jersey, United States Shionogi Inc. Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Director to join our team at Shionogi Inc. This role will provide essential support to the Executive Director in overseeing regulatory activities related to antiviral initiatives on a regional and/or global scale.Key ResponsibilitiesDevelop and execute regional regulatory strategies for antiviral...


  • Abbott Park, United States Abbott Laboratories Full time

    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.Working at...


  • Florham Park, United States Planet Pharma Full time

    Immediate Need for a Manager, Regulatory Affairs with a biotech company in Florham Park, NJ. Hybrid position with 2 days in office in Florham Park. 1 year renewable contract.Must have strong regulatory strategy experience.OverviewThe Contractor - Senior Manager, Regulatory Affairs - Quality of Life (QOL), plays a pivotal role in supporting the Senior...


  • florham park, United States Planet Pharma Full time

    Immediate Need for a Manager, Regulatory Affairs with a biotech company in Florham Park, NJ. Hybrid position with 2 days in office in Florham Park. 1 year renewable contract.Must have strong regulatory strategy experience.OverviewThe Contractor - Senior Manager, Regulatory Affairs - Quality of Life (QOL), plays a pivotal role in supporting the Senior...


  • florham park, United States Planet Pharma Full time

    Immediate Need for a Manager, Regulatory Affairs with a biotech company in Florham Park, NJ. Hybrid position with 2 days in office in Florham Park. 1 year renewable contract.Must have strong regulatory strategy experience.OverviewThe Contractor - Senior Manager, Regulatory Affairs - Quality of Life (QOL), plays a pivotal role in supporting the Senior...


  • Florham Park, United States Planet Pharma Full time

    Immediate Need for a Manager, Regulatory Affairs with a biotech company in Florham Park, NJ. Hybrid position with 2 days in office in Florham Park. 1 year renewable contract.Must have strong regulatory strategy experience.OverviewThe Contractor - Senior Manager, Regulatory Affairs - Quality of Life (QOL), plays a pivotal role in supporting the Senior...


  • Florham Park, New Jersey, United States AbbVie Full time

    Job DescriptionAbbVie is seeking a highly skilled and experienced Regulatory Affairs Director to join our Global Regulatory Strategy team. As a key member of our team, you will be responsible for developing and implementing global regulatory strategies to secure and maintain market approval for our products.The ideal candidate will have a strong...


  • Florham Park, United States Planet Pharma Full time

    Florham Park, NJ- onsite 2-3x a week1 year contract with potential to extendOverview:The Associate Director, Regulatory Affairs – GDP Contractor, provides essential support to the Executive Director in overseeing regulatory activities related to antiviral initiatives on a regional and/or global scale. This role involves assisting in the development and...


  • florham park, United States Planet Pharma Full time

    Florham Park, NJ- onsite 2-3x a week1 year contract with potential to extendOverview:The Associate Director, Regulatory Affairs – GDP Contractor, provides essential support to the Executive Director in overseeing regulatory activities related to antiviral initiatives on a regional and/or global scale. This role involves assisting in the development and...


  • Oak Ridge, Tennessee, United States Magicforce Full time

    Job Title: Regulatory Affairs SpecialistAt Magicforce, we are seeking a highly skilled Regulatory Affairs Specialist to join our team.Key Responsibilities:Ensure compliance with company Standard Operating Procedures and regulatory agency regulations/guidance.Represent Regulatory Affairs on cross-functional project teams.Provide technical expertise to...


  • Richmond Heights, Virginia, United States Commonwealth of Virginia Full time

    Job SummaryThe Commonwealth of Virginia is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our organization, you will be responsible for overseeing the regulatory program, records management, and policy development. Your expertise will be essential in ensuring compliance with statutory and regulatory...


  • Oak Ridge, Tennessee, United States Magicforce Full time

    Job Title: Regulatory Affairs SpecialistAt Magicforce, we are seeking a highly skilled Regulatory Affairs Specialist to join our team.Key Responsibilities:Ensure compliance with company Standard Operating Procedures and regulatory agency regulations/guidance.Represent Regulatory Affairs on cross-functional project teams.Provide technical expertise to...


  • Oak Ridge, Tennessee, United States Axiom Software Solutions Limited Full time

    Job Title: Regulatory SupportLocation: RemoteWe are seeking a highly skilled Regulatory Support professional to join our team at Axiom Software Solutions Limited. As a key member of our Regulatory Affairs team, you will play a critical role in ensuring compliance with company Standard Operating Procedures and regulatory agency regulations/guidance.Key...


  • Berkeley Heights, New Jersey, United States Breckenridge Pharmaceutical Inc Full time

    Job Title: Regulatory Affairs ManagerBreckenridge Pharmaceutical Inc is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with US drug product applications throughout the product lifecycle.Key Responsibilities:Compile high-quality...


  • Maryland Heights, Missouri, United States Yoh Full time

    {"title": "Regulatory Affairs Specialist", "description": "Regulatory Affairs SpecialistYoh is seeking a highly skilled Regulatory Affairs Specialist to join our team in St. Louis, Missouri. As a key member of our pharmaceutical client's regulatory team, you will be responsible for planning, authoring, and compiling drug product dossiers in CTD format for...


  • Arlington Heights, Illinois, United States Danaher Corporation Full time

    Job SummaryAt Danaher Corporation, we are committed to accelerating the real-life impact of tomorrow's science and technology. We are seeking a highly skilled Senior Director Global Regulatory Affairs to join our team.Key ResponsibilitiesDevelop and execute regulatory strategies for drug development and commercialization, ensuring compliance with global...


  • Berkeley Heights, New Jersey, United States Breckenridge Pharmaceutical Inc Full time

    Job SummaryBreckenridge Pharmaceutical Inc is seeking a highly skilled Regulatory Affairs Manager to join their team. The successful candidate will be responsible for ensuring compliance with US drug product applications throughout the product lifecycle.Key Responsibilities:Compile high-quality submissions, including ANDA/NDA modules, amendments,...


  • Florham Park, New Jersey, United States Planet Pharma Full time

    Job Title: Regulatory Affairs ManagerPlanet Pharma is seeking a highly skilled Regulatory Affairs Manager to support the development and execution of regulatory strategies for our quality-of-life initiatives.Key Responsibilities:Develop and execute regional regulatory strategies for quality-of-life initiatives.Provide strategic oversight and leadership to...


  • Baldwin Park, California, United States Ihealth Labs Inc Full time

    Job Title: Sr. Regulatory Affairs SpecialistJoin iHealth Labs Inc, a leading provider of cloud-connected medical devices, personal health care devices, and home-based tests, as a Sr. Regulatory Affairs Specialist. In this role, you will be part of the regulatory team responsible for proper oversight of medical device development and market introduction.Key...

Director, Code and Regulatory Affairs

4 months ago


Oak Park Heights, United States Renewal by Andersen Full time
Description & Requirements


ANDERSEN CORPORATION SUMMARY

At Andersen, we pride ourselves on our core values of Excellence, Integrity, Innovation, Partnership and being a leader in Corporate Citizenship. Headquartered in Bayport, Minn., Andersen Corporation is the largest window and door manufacturer in North America. Newsweek recognized Andersen as one of "2023 America's Greatest Workplaces."

We're focused on bringing more light into people's lives by helping them create healthier, happier spaces to build memories and do what they love. This applies to our team, too. Andersen embraces our nine Employee Resource Networks to celebrate our differences and to champion diversity. We are named as a Forbes "Best Employer for Diversity 2022."

Earning the 2023 ENERGY STAR Partner of the Year-Sustained Excellence Award, Andersen is also committed to environmental health and sustainability. No matter your role, you'll have the opportunity to make a difference at Andersen.

SUMMARY

Ensure that the enterprise is aware of and in compliance with all required standards, codes, and regulations and applicable voluntary standards. Develop and execute strategies to monitor, understand impact of, communicate, prioritize, and address international, national, and state building codes, regulatory legislation, select voluntary industry standards, and related program changes as they relate to enterprise products and the materials, components, and ingredients used in them. Work with industry associations and allies to influence pending standards, codes, and regulations consistent with Andersen enterprise values and positions. Represent the enterprise and strategically participate on or staff key code, regulatory and industry association activities.

PRIMARY RESPONSIBILITIES:

  • Lead and direct the activities of the code and regulatory affairs and product compliance teams
  • Develop strategic long-range goals for Andersen enterprise participation in international, national, state, and local code, regulatory, and standards arenas in support of business objectives.
  • Communicate pending changes related to above arenas while clearly articulating the possible business impact to internal delivery partners and stakeholders.
  • Gain alignment to and coordinate strategy with internal stakeholders, including Research and Development, Sales, Marketing, Legal, Government Relations, Sustainability, and Field Service for the Enterprise.
  • Develop and gain alignment with internal stakeholders around enterprise positions and priority of potential work related to these positions.
  • Develop, gain alignment for, and guide implementation of appropriate solutions by collaborating with Research & Development, engineering, procurement, supply chain, sales, marketing, and service.
  • Educate technical, marketing, and legal resources on how to understand, interpret, and address code, regulatory, and select voluntary program requirements.
  • As needed, retain outside professionals and services to interpret, understand impact of, and address pending changes related to these arenas.
  • Provide guidance to and support process enhancements related to product testing, certification, labeling, and regulatory compliance.
  • Develop and manage a communication process for alerting key internal stakeholders with respect to potential changes affecting individual business units or the Enterprise as a whole.
  • Communicate changes needed in content requirements or format for product labeling dictated by code, regulatory requirements, legislation, or third-party certifications.
  • Provide direction and support internal and external product compliance activities and resources, including managing the internal product compliance function.
  • Support legal department as needed for litigation in the areas of code and regulatory information, certification requirements, and Andersen practices.

MUST HAVE QUALIFICATIONS

  • Minimum of seven years of relevant work experience with a minimum of three years in a related leadership role.
  • Communications - An excellent communicator on technical and regulatory issues affecting business unit objectives (Excellent Written & Verbal skills).
  • Ability to learn and understand the technical aspects of our products and services.
  • Regulatory - Has extensive knowledge and familiarity with the major regulatory influences on each business unit.
  • Budget Management - Skilled at planning and managing the budget necessary to support regulatory affairs activities.
  • Foresight/Analysis - Capable of analyzing and communicating trends to help prepare the company in addressing emerging regulatory activity.
  • Coordination - Skilled at coordinating a wide array of internal and external resources in support of technical and regulatory issues.
  • Networking - Has developed or has the ability to develop extensive network of contacts, working relationships in the regulatory arena and industry associations and organizations (Persuasiveness).
  • Decision Making - Ability to make timely decisions in a fast-paced and rapidly changing environment.
  • Project prioritization - Works with key stakeholders to prioritize continually changing code, regulatory, legislative, and select voluntary program changes and requirements.
  • Demonstrated strategic thinking ability.
  • Facilitation skills


CULTURE AND BENEFITS

"Be Orange. Be You" is how we express our belief that by embracing our differences and empowering you, we'll be a stronger team able to accomplish what otherwise wouldn't be possible. This Orange spirit has helped us become the #1 innovative window and door brand* and the one homeowners love the most.** It's also why we're committed to supporting you to approach each day with a bright outlook.


Benefits include, and are not limited to:

* Medical/Dental/Vision/Life Insurance

* Health Savings Account contributions

* Paid holidays plus PTO

* 401(k) plan & contributions

* Professional development and tuition reimbursement opportunities

* Charity contributions

* Nationwide career opportunities


We look forward to seeing how your unique skills, background and experiences will inspire our team and help us continue to be the leader we are today.

In 2024, Andersen has set a profit-sharing target of $4,000 per eligible employee, prorated as appropriate. Profit sharing will be paid out in quarterly installments to provide eligible employees with payments throughout the year, with payment amounts tied to quarterly operating profit performance.

Andersen is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, disability, marital status, national origin, citizenship, genetic information, protected veteran status, or any other characteristic protected by law.

Posting City: Oak Park Heights, MN