Regulatory Affairs Manager jobs in Barnstable, MA

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)

B
Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • New Bedford, MA 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

V
Medical PER DIEM SPACE RENTAL-MEDICAL OFFICE
  • Veterans Evaluation Services-Veterans Affairs
  • Wareham, MA PER_DIEM
  • VES is seeking Per Diem space within 25 miles of WAREHAM, MA. Do you own a medical practice, Urgent Care, Physical Therapy, Concierge medicine, chiropractic office, med-spa or other facility that woul...
  • 26 Days Ago

C
Cosmetic Regulatory Compliance Coordinator
  • Commonwealth Soap & Toiletries
  • River, MA FULL_TIME
  • Scope: The Regulatory Compliance Specialist will provide expertise and ensure compliance with US and international regulatory requirements to help bring projects to market through collaboration with S...
  • 13 Days Ago

W
Graduate Admissions & Student Affairs Officer
  • Woods Hole Oceanographic Institution
  • Woods Hole, MA OTHER
  • Job Summary Reporting to the Associate Dean, the Graduate Admissions and Student Affairs Officer serves as a primary contact for applicants, students, and staff on admissions matters. Is committed to ...
  • 15 Days Ago

B
Executive Dean, Academic Affairs - Bristol Community College
  • Bristol Community College
  • River, MA FULL_TIME
  • Location: Fall River, MA Category: Professional Posted On: Fri Nov 3 2023 Job Description: POSITION TITLE: Executive Dean DEPARTMENT: Academic Affairs PRIMARY LOCATION: Fall River REPORTS TO: Vice Pre...
  • 1 Day Ago

C
Dean of Academic & Student Affairs, Health Sciences and Professional Studies - Cape Cod Community College
  • Cape Cod Community College
  • West Barnstable, MA FULL_TIME
  • Location: West Barnstable, MA Category: Administrative Positions Posted On: Thu May 4 2023 Job Description: GENERAL STATEMENT OF RESPONSIBILITIES: The Dean provides strategic leadership and direction ...
  • 10 Days Ago

Filters

Clear All

  • Filter Jobs by companies
  • More

0 Regulatory Affairs Manager jobs found in Barnstable, MA area

B
Physician Assistant/Nurse Practitioner-ICU
  • Beth Israel Lahey Health
  • Plymouth, MA
  • When you join the growing BILH team, you're not just taking a job, you're making a difference in people's lives. Job Typ...
  • 3/28/2024 12:00:00 AM

T
Electrician - 1st Shift
  • The Judge Group
  • Hyannis, MA
  • Since 1869 we've connected people through food they love. Our history was created by remarkable people, ideas, and innov...
  • 3/28/2024 12:00:00 AM

T
Quality Assurance Manager
  • The Judge Group
  • Hyannis, MA
  • Since 1869 we've connected people through food they love. Our history was created by remarkable people, ideas, and innov...
  • 3/28/2024 12:00:00 AM

T
Maintenance Technician - 2nd Shift (2:00PM-10:00PM)
  • The Judge Group
  • Hyannis, MA
  • Since 1869 we've connected people through food they love. Our history was created by remarkable people, ideas, and innov...
  • 3/28/2024 12:00:00 AM

G
On Site Property Manager
  • GreenKiss Staffing Solutions, Inc.
  • Hyannis, MA
  • Job Description Job Description Property Manager Pay Range:$70,835- $86,773/year Schedule: In- person Monday-Friday 8:30...
  • 3/28/2024 12:00:00 AM

W
Inventory Specialist
  • WALGREENS
  • Hyannis, MA
  • Responsible for executing, monitoring, and training inventory best practices and standard operating procedures for the e...
  • 3/27/2024 12:00:00 AM

T
Maintenance Technician - 3rd Shift (10:00PM-6:00AM)
  • The Judge Group
  • Hyannis, MA
  • Since 1869 we've connected people through food they love. Our history was created by remarkable people, ideas, and innov...
  • 3/27/2024 12:00:00 AM

R
Relationship Manager
  • Rockland Trust
  • Hyannis, MA
  • Rockland Trust is currently seeking a dynamic and client-focused Relationship Manager to join our Hyannis/Osterville tea...
  • 3/24/2024 12:00:00 AM

Barnstable (/ˈbɑːrnstəbəl/ BARN-stə-bəl) is a city, referred to as the Town of Barnstable, in the U.S. state of Massachusetts and the county seat of Barnstable County. Barnstable is the largest community, both in land area and population, on Cape Cod. At the 2010 census it had a population of 45,193. The town contains several villages (one of which is also named Barnstable) within its boundaries. Its largest village, Hyannis, is the central business district of the county and home to Barnstable Municipal Airport, the airline hub of Cape Cod and the islands of Martha's Vineyard and Nantucket. A...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Manager jobs
$146,226 to $206,250
Barnstable, Massachusetts area prices
were up 1.6% from a year ago

Regulatory Affairs Manager in Pittsfield, MA
The ideal candidate will have strong working knowledge of the agrochemical regulatory requirements.
December 24, 2019
Regulatory Affairs Manager in Stockton, CA
The world’s leading research-based pharmaceutical and healthcare companies is looking for a Regular Affairs Manager.
December 01, 2019
Regulatory Affairs Manager in Pierre, SD
Pharmaceutical companies, cosmetics manufacturers, food producers, and medical device suppliers hire regulatory affairs managers to make sure they adhere with all regulations.
February 01, 2020