Regulatory Affairs Director jobs in Lorain, OH

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)

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Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Amherst, OH FULL_TIME
  • Bausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurology, Ortho Dermatologics, Medical Aesthetics and Dentistry. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. Each day, Bausch Health products are used by over 150 million people around the world.

    Our approximately 7,000 employees are united around our mission of improving peoples lives with our health care products.

    The Executive Director of Advertising & Promotion- Regulatory Affairs prescription drug products manages and, if required participates in, the reviews and approvals of advertising and promotional labeling pieces for prescription drugs. The Executive Director is responsible for ensuring the pieces are in compliance with regulatory agencies requirements.

    Responsibilities:

    • Manages the Regulatory Promotional reviews for prescription drugs who represent Regulatory Affairs on the promotional review committee for marketed products. This position may require reviewing promotional materials if the company requires it. This person is responsible for compliance with regulatory requirements while meeting Company's strategic promotional objectives.

    • Provide guidance on proposed claims for products in development and development of ISI and brief summaries.

    • Regularly monitor the regulatory compliance trends in industry, interpret new regulations, guidance documents and enforcement letters. Update the Regulatory Ad Promo staff, review committees and appropriate other company staff regarding changes in the current regulatory environment at FDA's Office of Prescription Drug Promotion (OPDP) and other regulatory considerations that may impact business. Develop or revise procedures as needed.

    • Review packages for regulatory advice, resolution of FDA action letters and leads the company in discussions with OPDP.

    • Coordinate companywide ongoing regulatory training on regulatory issues pertaining to promotion of Company products.

    • Represents regulatory affairs in cross functional prescription product promotional review teams as required, participate in development committees for processes and procedures relating to ad promo.

    • Interacts with Quality related to internal audits and CAPAs, as needed.

    Qualifications:

    • Bachelor Degree in science or health related discipline required (Advanced degree PhD, MD, MS, PharmD preferred)

    • 12 years of pharmaceutical experience with 10 years of regulatory affairs product advertising and promotion experience required.

    • GI experience strongly preferred

    • Broad knowledge of the pharmaceutical industry. Demonstrated ability to contribute to a continuous learning and process improvement environment.

    • Detail-oriented with the ability to promptly assess documents for accuracy as well as consistency

    • Strong interpersonal skills with the ability to influence others in a positive and effective manner

    • Ability to work in a team environment

    • Working knowledge of Rx NDA development and approval process

    • Excellent communication skills; both oral and written

    As required by law, Bausch Health provides a reasonable range of compensation for roles that may be hired in the US. Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location. For this role, the range of starting pay for this role is 280K – 320K.

    Benefits package includes a Comprehensive Medical (includes Prescription Drug), Dental, Vision, Health Savings Account with company contribution, Flexible Spending Accounts, 401(k) matching, 3-weeks paid time off plus 6 days paid sick time (unless a state or city-specific policy applies) to start (pro-rated for new hires), tuition reimbursement, parental leave, short-term disability, long-term disability, life insurance, accidental death & dismemberment insurance, 12 paid holidays (including floating holidays), Employee Assistance Plan, commuter benefit, recognition awards, voluntary benefits (including Identity Theft, Student Loan and Breast Milk Shipping), employee referral bonuses and employee discounts.

    This position may be available in the following location(s): [[location_obj]]

    We thank you in advance for your interest in growing and developing with Bausch Health. Kindly note that in order for all stakeholders to be successful, we do require a minimum of one year in your current role before applying to another one. Please ensure you have discussed with your current manager the intent of applying to a new role.

    Any exception will have to be authorized by your HR Business Partner.

    Bausch Health Companies Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment regardless of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.

    If a candidate needs a reasonable accommodation/adjustment due to physical or mental health impairment for any part of the application process, they are encouraged to send their request to humanresources@bauschhealth.com or call 908-927-1400 and let us know the nature of the request and their contact information. Please be sure to include the job requisition number.

    Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

    To learn more please read Bausch Health's Job Offer Fraud Statement (https://protection.greathorn.com/services/v2/lookupUrl/c29afa19-107c-4ce0-9f8c-cdaacd1f6318/176/379301a79c224eae9f25e08c7426cedde0ec4807) .

    Bausch Health is an EEO/AA employer M/F/D/V.

  • 11 Days Ago

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Activities Director - Activities Director
  • Legacy Health Services
  • Bucyrus, OH FULL_TIME
  • Summary The Activities Director will be responsible for planning, organizing, developing, and directing the overall operations of the Activity Department. The Activity Department is a vital component ...
  • 3 Days Ago

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Center Director
  • KinderCare Education
  • Avon, OH FULL_TIME
  • Futures start here. Where first steps, new friendships, and confident learners are born. At KinderCare Learning Companies, the first and only early childhood education provider recognized with the Gal...
  • 20 Days Ago

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Preschool Director
  • CHRIST LUTHERAN PRESCHOOL
  • Avon, OH FULL_TIME
  • Preschool Director – Christ Lutheran Preschool, Avon Lake, Ohio General Position Description The Preschool Director is responsible for ensuring the health, safety, and quality of education for all chi...
  • 20 Days Ago

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Activity Director
  • Continuing Healthcare of Milan
  • Milan, OH FULL_TIME
  • Job Description: This is a great time to consider joining Continuing Healthcare Solutions as a Activity Director! Now offering the best opportunities in long term care for our Activity Director's. We ...
  • 25 Days Ago

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Executive Director
  • LakeHouse Senior Living
  • Sandusky, OH FULL_TIME
  • About LakeHouse Senior Living LakeHouse Senior Living proudly manages 39, care- and lifestyle-focused Active Independent Living, Assisted Living, Memory Care, and available, short-term Respite Care co...
  • 25 Days Ago

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0 Regulatory Affairs Director jobs found in Lorain, OH area

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Assistant Controller, eGaming
  • Arrow International, Inc.
  • Cleveland, OH
  • Job Type Full-time Description Arrow International is the world's largest manufacturer and supplier of charitable gaming...
  • 3/28/2024 12:00:00 AM

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Director of Site Selection (Southeastern Region - TN)
  • Stark Enterprises
  • Cleveland, OH
  • The Director of Site Selection will play a pivotal role in identifying, evaluating, and acquiring strategic land parcels...
  • 3/28/2024 12:00:00 AM

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Unit Manager Nurse (LPN or RN)
  • Wesleyan Village
  • Elyria, OH
  • Wesleyan Village - Wesleyan Village is seeking a compassionate and professional Unit Manager (UM) for our skilled nursin...
  • 3/28/2024 12:00:00 AM

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Chief Financial Officer CFO
  • ExecuTech Search
  • Cleveland, OH
  • Job Description Job Description The Chief Financial Officer will oversee all financial strategy & operations. This role ...
  • 3/26/2024 12:00:00 AM

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Executive Director
  • Careerbuilder
  • Wickliffe, OH
  • Overview Make Lives Better Including Your Own . If you want to work in an environment where you can become your best pos...
  • 3/26/2024 12:00:00 AM

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RN Executive Director Home Health
  • Heartland Home Health
  • Independence, OH
  • Our Company: Heartland Home Health is a member of the Gentiva family - an industry leader in hospice, palliative, home h...
  • 3/25/2024 12:00:00 AM

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Hospice Executive Director - RN
  • LHC New
  • Richfield, OH
  • Summary We are hiring for an Executive Director in Hospice. At Caretenders Hospice, a part of LHC Group, we embrace a cu...
  • 3/25/2024 12:00:00 AM

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STNA/RA
  • LCS Senior Living
  • Avon, OH
  • When you work at Rose Senior Living Avon, you have a front-row seat to the amazing life stories of the wisest people on ...
  • 3/24/2024 12:00:00 AM

Lorain /ləˈreɪn/ is a city in Lorain County, Ohio, United States. The municipality is located in northeastern Ohio on Lake Erie, at the mouth of the Black River, approximately 30 miles west of Cleveland. As of the 2010 census, the city had a total population of 64,097, making it Ohio's tenth largest city, the third largest in Greater Cleveland, and the largest in Lorain County by population. The city is notable for its deindustrialized economy, formerly being home to the American Ship Building Company Lorain Yard, Ford Motor Company Lorain Assembly Plant, and United States Steel Corporation's...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Director jobs
$164,612 to $234,444
Lorain, Ohio area prices
were up 1.3% from a year ago

Regulatory Affairs Director in Spartanburg, SC
There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful.
December 13, 2019
Regulatory Affairs Director in New Brunswick, NJ
The apprenticeship programme lasts 30 months and provides a combination of Masters-level training in regulatory affairs and paid work experience.
February 12, 2020
Regulatory Affairs Director in Syracuse, NY
They often advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
January 18, 2020