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Regulatory Affairs Manager

Regulatory Affairs Manager

Meitheal PharmaceuticalsChicago, IL, United States
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Founded in 2017 and based in Chicago, Meitheal is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, bi...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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Regulatory Affairs Intern

Regulatory Affairs Intern

RegASKSan Antonio, TX, US
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RegASK is an AI-driven solution enabling end-to-end intelligent regulatory workflow orchestration : automating regulatory intelligence with curated content and actionable insights, smart documentati...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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Director, Regulatory Affairs

Director, Regulatory Affairs

New Hampshire StaffingConcord, NH, US
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Japan with key operations in the U.Canada, and Europe focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies.With...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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Regulatory Affairs Specialist

Regulatory Affairs Specialist

Wisconsin StaffingMadison, WI, US
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Regulatory Compliance Specialist.Division Information Spectrum Brands' Home & Personal Care (HPC) Appliances business participates on a global basis in small electric appliances, shave / groom applia...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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Regulatory Affairs Associate

Regulatory Affairs Associate

Spectraforce TechnologiesNorth Chicago, IL, United States
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Hybrid in Lake County, IL 60064.Individual is responsible for managing the activities for marketed product variations including authoring and compilation of chemistry, manufacturing, and control (C...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
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Regulatory Affairs Specialist

Regulatory Affairs Specialist

Matlen SilverCary, IL, United States
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Senior Regulatory Affairs Specialist (12-Month Contract).Minimum 9 years of relevant regulatory experience.Senior Regulatory Affairs Specialist. This role will be instrumental in driving compliance ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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Regulatory Affairs Associate

Regulatory Affairs Associate

EnvistaBrea, CA, US
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The Regulatory Affairs Associate (RAA) supports the RA team in creating, evaluating and completing regulatory tasks related to worldwide product registration submissions, facility registrations, sp...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
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Manager, Regulatory Affairs

Manager, Regulatory Affairs

Harbor HealthSan Antonio, TX, US
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At Harbor Health, we're transforming healthcare in Austin through collaboration and innovation.We're seeking passionate individuals to help us create a member-centered experience that connects comp...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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Manager, Regulatory Affairs

Manager, Regulatory Affairs

AmerisourceBergen Corporation (Cencora)Atlanta, GA, United States
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Our team members are at the heart of everything we do.At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
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Regulatory Affairs Specialist

Regulatory Affairs Specialist

Veterans StaffingScottsdale, AZ, US
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The Regulatory Affairs Specialist is responsible for preparing and submitting documentation for pre-market submissions, including FDA 510(k) submissions and Health Canada Medical Device License App...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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Manager, Regulatory Affairs

Manager, Regulatory Affairs

KMR Search GroupPortland, OR, US
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This position supports both their individual and overall departmental goals regarding the number of filings to be submitted and approved yearly by planning, managing and assuring the quality of the...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Regulatory Affairs Coordinator

Regulatory Affairs Coordinator

A-Line Staffing Solutions LLCIrvine, CA, US
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Title : Regulatory Affairs Coordinator III.Location : Irvine, CA (Hybrid) – Position is open to Fully Remote candidates.Note : This is a W2 contract role – C2C & 3 rd party candidates WILL NOT be cons...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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Regulatory Affairs Manager

Regulatory Affairs Manager

Katalyst Healthcares & Life SciencesSan Diego, CA, US
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Regulatory Affairs Professional.We are looking for an energetic and self-motivated Regulatory Affairs professional who will provide global regulatory expertise and strategic leadership to our IVD p...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
Regulatory Affairs Specialist

Regulatory Affairs Specialist

AxogenTampa, Florida, USA
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Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands-on and personal approach makes transitioning to a new job a seamle...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
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Regulatory Affairs Specialist

Regulatory Affairs Specialist

RandstadChesterfield, MO, US
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We are seeking a highly organized and detail-oriented Regulatory Affairs Specialist to support our team in managing state regulatory activities for crop protection products.This role is critical fo...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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Director, Regulatory Affairs

Director, Regulatory Affairs

StrykerTempe, AZ, US
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The Director, Regulatory Affairs is a key strategist, responsible for developing and executing the global regulatory strategy for Stryker Sustainability Solutions (SSS) business unit focused on pro...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
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Director, Regulatory Affairs

Director, Regulatory Affairs

BeiGenePhoenix, AZ, US
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BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals.When considering candidates, we look for scientific and business professionals who ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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Regulatory Affairs Specialist

Regulatory Affairs Specialist

OSI SystemsNorth Billerica, MA, US
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Rapiscan, an OSI Systems Company is seeking a Regulatory Affairs Specialist based out of Billerica, MA.Rapiscan Systems, an OSI Systems, Inc. Our products are used to inspect baggage, cargo, people,...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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Regulatory Affairs Specialist

Regulatory Affairs Specialist

DexComArlington, TX, US
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Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM).Dexcom began as a small company with a big dream : To forever change how diabetes is managed.To...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Regulatory Affairs Manager

Regulatory Affairs Manager

Meitheal PharmaceuticalsChicago, IL, United States
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Job Type

Full-time

Description

About Us :

Founded in 2017 and based in Chicago, Meitheal is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and branded products. Meitheal currently markets over 60 U.S. Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of January 2025, Meitheal, directly or through its partners, has 19 products in the research and development phase, 22 additional products planned for launch in 2025, and 24 products under review by the FDA. Meitheal's mission is to provide easy access to fairly priced products through robust manufacturing, consistent supply, and rapid response to our customers' needs. Ranked #2 in 2024 on Crain's Fast 50 in Chicago, and in the top 100 of Crain's Best Places to Work in Chicago from 2022 to 2024, Meitheal emulates the traditional Irish guiding principle we are named for - working together toward a common goal, for the greater good.

Position Summary :

The Regulatory Affairs Manager (CMC) position is responsible for the author, review, preparation and manage on-time filing of high-quality regulatory submissions and for post-approval maintenance of regulatory dossiers with an emphasis on CMC.

The pay range for this position is : $85,000 - $115,000.

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and / or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

Why Work with Us?

  • Hybrid Work Schedule : Enjoy the flexibility to work remotely three days a week.
  • Casual Dress Code : Embrace a relaxed and comfortable dress code that allows you to express your personal style.
  • Collaborative Culture : Join a team that values open communication, teamwork, and the exchange of ideas.
  • Professional Growth : We offer ample opportunities for professional development and career advancement.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

  • The primary responsibility will include authoring, reviewing and preparing high quality ANDA, NDA, BLA, IND and DMF submissions.
  • Prepare, review and submit responses to FDA's CRLs, DRLs and Information Requests within predetermined and negotiated deadlines.
  • Review and submit post-approval supplements, safety update reports to INDs, NDAs, ANDAs and BLAs.
  • Participate in development and commercial team meetings representing RA CMC.
  • Review and approve change controls from global manufacturing partners
  • Experienced with FDA's eCTD requirements for Modules 1-5.
  • Work in a collaborative environment with cross-functional teams, not limited to Labeling, R&D, Manufacturing, Medical Affairs, Operations, Marketing and Quality.
  • Adhere to submission timelines as per the internal tracking. Administration and management of assigned products. Perform other duties as assigned by the Supervisor.
  • Maintains current knowledge of regulations. Serves as the primary regulatory interface with US FDA manufacturing partners (domestic and international), and internal teams to ensure the business needs for the assigned products are met by anticipating, identifying, prioritizing and mitigating regulatory risks while following all regulatory requirements.
  • Support Biosimilar BLA / PAS / CBE submissions, as assigned.

    • Competencies

  • Planning and Organizing
  • Communication
  • Strategic Thinking
  • Teamwork
  • Problem Solving
  • Quality
  • Judgement
  • Dependability

    • Qualifications

    To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and / or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

  • Assimilate to changing environments.
  • Ability to prioritize and multitask.
  • Organized and detailed orientated.
  • Have a sense of urgency to meet all required deadlines

    • Education and / or Experience :

  • Bachelor's degree in life sciences from a 4-year college or university with 5 or more years of direct experience in Regulatory Affairs within bio / pharmaceutical companies, with focus in CMC. Candidates with additional prior experience in R&D or Manufacturing will be a plus.
  • Excellent attention to details, technical writing, organizational and communication skills.
  • Ability to prioritize and handle multiple projects concurrently.
  • Familiar with 21 CFR, FDA and ICH.

    • Equal Opportunity Employer :

    Meitheal Pharmaceuticals is an Equal Opportunity Employer. We welcome and encourage applications from all qualified individuals, including minorities, women, veterans, and individuals with disabilities.

    Salary Description

    $85,000 to $115,000