Regulatory Affairs Director jobs in Stockton, CA

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
  • Stockton, CA 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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Associate Director of Student Affairs
  • IEC CORP GROUP
  • Stockton, CA OTHER
  • Job Details Job Location: California Stockton UEI - Stockton, CA Salary Range: $65,000.00 - $69,000.00 Salary/year Job Category: Instructors & Education DescriptionUEI College is a leader in post-seco...
  • 24 Days Ago

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Regulatory Compliance Analyst
  • Delicato Family Wines
  • Manteca, CA FULL_TIME
  • Work Location Delicato Vineyards Manteca Position Purpose Under minimal supervision, the Regulatory Compliance Analyst is responsible for execution of projects in assigned functional areas and oversig...
  • 26 Days Ago

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Regulatory Manager - California
  • CRH
  • Stockton, CA FULL_TIME
  • Job ID: 492443 Exempt Oldcastle Infrastructureâ„¢, a CRH company, is the leading provider of utility infrastructure solutions for the water, energy, and communications markets throughout North America. ...
  • 1 Month Ago

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Vice President Clinical Affairs California (Market Chief Medical Officer)
  • P3 Health Partners
  • Stockton, CA FULL_TIME
  • P3 is a patient-centered, physician-led, healthcare service with a big heart and an even bigger vision: to lead healthcare in a new direction by cultivating wellness, not just managing illness. We do ...
  • 8 Days Ago

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Vice President Clinical Affairs California (Market Chief Medical Officer)
  • P3 Health Partners Brand
  • Stockton, CA FULL_TIME
  • P3 is a patient-centered, physician-led, healthcare service with a big heart and an even bigger vision: to lead healthcare in a new direction by cultivating wellness, not just managing illness. We do ...
  • 9 Days Ago

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0 Regulatory Affairs Director jobs found in Stockton, CA area

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RN Branch Director, Home Health
  • Humana Inc.
  • Stockton, CA
  • Become a part of our caring community and help us put health first The Branch Director is accountable for managing the d...
  • 3/28/2024 12:00:00 AM

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Senior Technical Lead - Design - Electrical Utilities
  • Entrust Solutions Group
  • Stockton, CA
  • What You'll Do: Serve as the engineering support technical advisor to the Director Lead all design, drafting and support...
  • 3/28/2024 12:00:00 AM

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Project Manager
  • City of Lathrop, CA
  • Lathrop, CA
  • Salary : $130,913.00 - $159,125.00 Annually Location : Lathrop, CA Job Type: Full-Time Job Number: 2400098 Department: P...
  • 3/28/2024 12:00:00 AM

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Senior Technical Lead - Design - Electrical Utilities
  • Entrust Solutions Group
  • Sacramento, CA
  • What You'll Do: Serve as the engineering support technical advisor to the Director Lead all design, drafting and support...
  • 3/28/2024 12:00:00 AM

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Director of Special Investigations (Workers Compensation)
  • Berkshire Hathaway Homestate Companies
  • Sacramento, CA
  • WHO WE ARE Berkshire Hathaway Homestate Companies is dedicated to being the best workers compensation insurance company ...
  • 3/28/2024 12:00:00 AM

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TPPM Program Manager
  • SAN JOAQUIN COUNTY HEALTH COMMISSION
  • French Camp, CA
  • Job Description Job Description The expected pay range is based on many factors such as geography, experience, education...
  • 3/27/2024 12:00:00 AM

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Program Manager
  • City of Sacramento, CA
  • Sacramento, CA
  • Salary : $104,066.20 - $136,543.87 Annually Location : Sacramento, CA Job Type: Full-Time Career Job Number: 001798-24-D...
  • 3/26/2024 12:00:00 AM

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Director, CMC Regulatory Affairs
  • Bayside Solutions
  • Fremont, CA
  • Director, CMC Regulatory Affairs Direct Hire Fulltime Role Salary Range: $208,000 - $235,000 per year Location: Redwood ...
  • 3/24/2024 12:00:00 AM

Stockton is the county seat of San Joaquin County in the Central Valley of the U.S. state of California. Stockton was founded by Captain Charles Maria Weber in 1849 after he acquired Rancho Campo de los Franceses. The city is named after Robert F. Stockton, and it was the first community in California to have a name not of Spanish or Native American origin. The city is located on the San Joaquin River in the northern San Joaquin Valley and had an estimated population of 320,554 by the California Department of Finance for 2017. Stockton is the 13th largest city in California and the 63rd larges...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Director jobs
$180,118 to $256,527
Stockton, California area prices
were up 2.5% 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