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Manager Chemistry Manufacturing Control Jobs (NOW HIRING)

Abbott

Regulatory Affairs Associate

South Portland, ME · On-site

$19 - $21/hr

Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC). * Ensures timely approval of new ...

Freseniusglobal

Manager, Chemistry

Wilson, NC · On-site

Interact with Manufacturing and Quality Assurance on a routine basis. Salary Range: $90,816 - $126 ... Provides evaluation and quality control recommendations for new processes relevant to chemistry ...

Fresenius Kabi USA, LLC

Manager, Chemistry

Wilson, NC · On-site

Interact with Manufacturing and Quality Assurance on a routine basis. Salary Range: $90,816 - $126 ... Provides evaluation and quality control recommendations for new processes relevant to chemistry ...

Fresenius Kabi

Manager, Chemistry

Wilson, NC · On-site

Interact with Manufacturing and Quality Assurance on a routine basis. Salary Range: $90,816 - $126 ... Provides evaluation and quality control recommendations for new processes relevant to chemistry ...

Cynet Systems

Regulatory Affairs Associate

Portland, ME · On-site

$15.53 - $20.53/hr

Chemistry manufacturing control (CMC). * Risk management. * Technical labeling. == Benefits Our Benefits Include: * Medical, Dental, and Vision Insurance * 401(k) Retirement Plan * Health Savings ...

SC Johnson

Associate Manager, Chemistry

Racine, WI · Hybrid

$22.75 - $30/hr

ABOUT THE ROLE As Associate Manager, Chemistry supporting the AMET region, you will lead a variety ... Familiar with the range of SC Johnson categories and related technologies, including Pest Control ...

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Regulatory Affairs Associate

South Portland, ME • On-site

Abbott
See more jobs at Abbottexternal

$19 - $21/hr

Contractor

Medical, Dental, Vision, Life, Retirement

Re-posted 8 days ago

Key responsibilities

  • Assist in the development, review, and initiation of standard operating procedures and stay updated on regulatory procedures and changes.

  • Compile, organize, and oversee the preparation of regulatory submission and registration packages, including quality control and meeting organization.

  • Update and maintain global product listings, facility registrations, licenses, and prepare reports and communications related to postmarket activities.

Abbott rating

7.8

Company rating: 7.8 out of 10

Based on 139 frontline employees who took The Breakroom Quiz

Job description

Title: Regulatory Affairs Associate
Location: South Portland, ME
Duration: 12 Months
Shifts: 8AM TO 4:30PM
100% Onsite
Main Responsibilities:
  • As the Experienced para-professional in the Regulatory Affairs Sub-Function, possesses specialized knowledge in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
  • Strategic Planning: Assist in SOP development, review and initiation; Stay abreast of regulatory procedures and changes in regulatory climate and update department; Investigate regulatory history of similar products to assess approval implications; Conduct research on submission requirements and options; Assist in monitoring and reporting project timelines; Respond to regulatory information requests; and Monitor and utilize tracking and control systems.
  • Premarket: Compile and organize materials for presubmission reports; Coordinate and assist in the preparation of submission/registration packages; Coordinate registration requests and track completion; Implement submission templates; Oversee quality control of regulatory documents and submissions; and Organize meetings with regulatory agency staff.
  • Postmarket: Update and maintain global product listings, facility registrations, licenses/approvals, and annual registrations; Assist in the preparation of routine reports and regulatory agency communications; Assist in the preparation of postmarket reports and submissions; Update and maintain paper/electronic document archival systems; Prepare legal documents for import/export, registrations, tenders/bids or other purposes;
  • Serves as regulatory liaison throughout product lifecycle.
  • Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).
  • Ensures timely approval of new medical devices and continued approval of marketed products.
  • Serves as regulatory representative to marketing, research teams.
  • Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.

Main Purpose Of The Role:
  • Experienced para-professional individual contributor working under limited supervision within the Regulatory Affairs sub-function.
  • Applies subject matter knowledge in the area of Regulatory Affairs.
  • Requires capacity to apply skills/knowledge within the context of specific needs or requirements.

Main Responsibilities:
  • As the Experienced para-professional in the Regulatory Affairs Sub-Function, possesses specialized knowledge in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
  • Strategic Planning: Assist in SOP development, review and initiation; Stay abreast of regulatory procedures and changes in regulatory climate and update department; Investigate regulatory history of similar products to assess approval implications; Conduct research on submission requirements and options; Assist in monitoring and reporting project timelines; Respond to regulatory information requests; and Monitor and utilize tracking and control systems.
  • Premarket: Compile and organize materials for presubmission reports; Coordinate and assist in the preparation of submission/registration packages; Coordinate registration requests and track completion; Implement submission templates; Oversee quality control of regulatory documents and submissions; and Organize meetings with regulatory agency staff.
  • Postmarket: Update and maintain global product listings, facility registrations, licenses/approvals, and annual registrations; Assist in the preparation of routine reports and regulatory agency communications; Assist in the preparation of postmarket reports and submissions; Update and maintain paper/electronic document archival systems; Prepare legal documents for import/export, registrations, tenders/bids or other purposes;
  • Serves as regulatory liaison throughout product lifecycle.
  • Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).
  • Ensures timely approval of new medical devices and continued approval of marketed products.
  • Serves as regulatory representative to marketing, research teams.
  • Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.

Consultants Eligible Benefits Upon Waiting Period:
  • Medical and Prescription Drug Plans
  • Dental Plan
  • Vision Plan
  • Health Savings Account (for High-Deductible Health Plans)
  • Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
  • Supplemental Life Insurance
  • Short Term Disability (coverage varies by state)
  • Long Term Disability
  • Critical Illness, Hospital coverage, Accident Insurance
  • MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
  • 401(k)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.
Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.
  • Published on 04 Aug 2026, 9:17 PM

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