Regulatory Affairs Director jobs in Michigan

Regulatory Affairs Director oversees regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Director establishes 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 Director investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Regulatory Affairs Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)

P
Senior Director Regulatory Affairs
  • Perrigo Company plc
  • Grand Rapids, MI FULL_TIME
  • Perrigo Company is dedicated to making lives better by bringing Quality, Affordable Self-care products that consumers trust everywhere they are sold. Help us do it.

    External applicants please note: To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) Thank you.

    Description Overview

    Support the Perrigo Over-the-Counter (OTC) Business Unit through strategic leadership of staff responsible for the hands-on regulatory activities associated with bringing new Brand and Store Brand products to market and maintenance of commercialized products for US and Canadian product categories including New Drugs, Abbreviated New Drugs, Medical Devices, Dietary Supplements, Natural Health Products, and Cosmetics. Additionally, provide strategic regulatory guidance to Marketing and Business Development staff in developing growth strategies to enter new business segments, product categories, technology and inorganic acquisitions in support of the OTC Business Unit.

    Scope of the Role

    • Confirm that project plan due dates are consistent with regulatory strategy
    • Work directly with Regulatory Agencies to resolve regulatory issues
    • Direct and manage contacts with outside consultants to resolve regulatory issues
    • Represent regulatory affairs in leadership meetings
    • Ensure appropriate basis to marketing strategies are identified and/or implemented; Identify and employ advanced regulatory strategies
    • Communicate and collaborate with cross-function OTC management staff
    • Support and lead a continuous improvement environment
    • Provide oversight for OTC RA processes and systems
    • Hire, train and evaluate performance of direct reports
    • Manage and prioritize OTC RA resources
    • Manage projects as assigned by CSCA VP of RA or OTC business unit leader
    • Work directly with FDA, Health Canada, trade associations and outside regulatory and legal experts to influence emerging legislation, regulations, guidances and FDA decision making on matters material to Perrigo OTC BU with support from CSCA RA VP
    • Develop strategies and tactics to support first to market commercial opportunities and minimize time to product launch
    • Mentor staff to maximize the leadership talent pool

    Experience Required

    • Must demonstrate advanced analytical skills, the ability to identify and apply policies and general regulations to specific products or projects and create new policies as required
    • Ability to monitor, analyze, raise awareness, and assess impact of regulatory issues for executive stakeholders inside and outside of Regulatory Affairs
    • Advanced verbal and written presentation and communication skills are necessary
    • Ability to utilize advanced business and financial acumen in decision making
    • The ability to effectively lead cross-functional management-level teams is required
    • Advanced knowledge of scientific, regulatory, and legal terminology is necessary
    • These skills are normally acquired through possession of a bachelor’s degree in a health sciences field such as biochemistry, chemistry, pharmacy, pharmacology combined with 10 years of experience in the health care or pharmaceutical industry and 10-12 years of hands-on experience in regulatory affairs
    • 10 or more years of experience in direct supervision
    • Advanced degree preferred

    External applicants please note: To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) Thank you.

    We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. Our full Equal Employment Opportunity and Affirmative Action Policy Statement is available on our main career site in English and Spanish and will be provided in other accessible forms for persons with disabilities. #DIV
  • 1 Day Ago

V
Director, Regulatory Affairs
  • Volkswagen Group of America - Chattanooga...
  • Auburn, MI FULL_TIME
  • Director, Regulatory Affairs - EEO000221 - Hybrid Primary Location United States-Michigan-Auburn Hills Role Summary: This role serves as the lead regulatory and technical policy coordinator for emissi...
  • 11 Days Ago

E
Senior Manager, Regulatory Affairs
  • EV.Careers
  • Troy, MI FULL_TIME
  • Job Number: 61508Group: Magna CorporateDivision: Magna Services of America (Troy Office)Job Type: Permanent/RegularLocation: TROYGroup DescriptionAt Magna, we create technology that disrupts the indus...
  • 7 Days Ago

M
Regulatory Affairs Specialist II
  • myGwork - LGBTQ+ Business Community
  • Maple, MI FULL_TIME
  • This inclusive employer is a member of myGwork – the largest global platform for the LGBTQ business community. Recruiter: Spencer Gregory HaleRegulatory Affairs Specialist IIAbout The RoleAt Boston Sc...
  • 8 Days Ago

T
Regulatory Affairs Engineer
  • Talent Acquisition Team
  • Caledonia, MI FULL_TIME
  • ESSENTIAL DUTIES AND RESPONSIBILITIES: Supports the review of updated technical publications and standards to ensure continued compliance Supports the Customer Complaint process and performs MDR and v...
  • 9 Days Ago

C
Regulatory Affairs Specialist
  • Chromatech Inc. & B.V.
  • Canton, MI FULL_TIME
  • At Chromatech, we create color solutions in a wide variety of markets around the globe. You can become part of our Chromatech team by joining as a Regulatory Affairs Specialist. The right candidate wi...
  • 9 Days Ago

E
Head of Regulatory Affairs
  • Exegenesis Bio Inc
  • Ambler, PA
  • Job Description Job Description Job Title: Head of Regulatory Science Reports to (Title): CEO Location: Remote, US Exemp...
  • 6/11/2024 12:00:00 AM

E
Head of Regulatory Affairs
  • EPM Scientific
  • Our client, a clinical stage biotech company, is seeking an experienced and dynamic Head of Regulatory Affairs to join t...
  • 6/10/2024 12:00:00 AM

V
Director of Regulatory Affairs
  • Verano
  • Verano Holdings Corp. (CSE: VRNO) (OTCQX: VRNOF), one of the U.S. cannabis industry’s leading companies based on histori...
  • 6/10/2024 12:00:00 AM

H
Head of Regulatory Affairs
  • Hiring Now!
  • West Hills, CA
  • HELP US BRING THE GIFT OF HEALTH TO LIFE.Working at Pharmavite is an experience like no other. With a focus on complete ...
  • 6/8/2024 12:00:00 AM

C
Director of Regulatory Affairs
  • Catalyst Life Sciences
  • Our client is actively looking for a (Senior) Director of RA/QA to join their growing team. This is a hybrid position su...
  • 6/8/2024 12:00:00 AM

K
Head of Regulatory Affairs
  • Kaye/Bassman International
  • San Diego, CA
  • Position Title: Head of Regulatory Affairs Location: Southern California Company Overview: We are partnered with a cutti...
  • 6/7/2024 12:00:00 AM

M
Sr. Director of Regulatory Affairs - Oncology
  • Mantell Associates
  • Boston, MA
  • Mantell Associates is currently partnered with an innovative Biotech company, developing much-needed therapies for peopl...
  • 6/7/2024 12:00:00 AM

V
Director of Regulatory Affairs
  • Verano
  • Chicago, IL
  • Verano Holdings Corp. (CSE: VRNO) (OTCQX: VRNOF), one of the U.S. cannabis industry’s leading companies based on histori...
  • 6/7/2024 12:00:00 AM

Michigan consists of two peninsulas that lie between 82°30' to about 90°30' west longitude, and are separated by the Straits of Mackinac. The 45th parallel north runs through the state—marked by highway signs and the Polar-Equator Trail—along a line including Mission Point Light near Traverse City, the towns of Gaylord and Alpena in the Lower Peninsula and Menominee in the Upper Peninsula. With the exception of two small areas that are drained by the Mississippi River by way of the Wisconsin River in the Upper Peninsula and by way of the Kankakee-Illinois River in the Lower Peninsula, Michigan...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Director jobs
$167,688 to $238,831

Regulatory Affairs Director in Gary, IN
At the Healthcare Professionals Group, our experienced team of Regulatory & Quality recruitment consultants are ready to discuss a variety of Regulatory Affairs Director jobs with you.
February 18, 2020
Regulatory Affairs Director in Springfield, OR
The regulatory affairs director might engage in reading and responding to letters from the FDA, including any “warning letters” about unapproved activities or products.
December 04, 2019
Regulatory Affairs Director in Richmond, VA
The office of regulatory affairs is a dynamic work environment where communication with employees at all levels within the organization is extremely important.
December 05, 2019