Senior Regulatory Affairs Specialist

2 months ago

Green Oaks, United States Abbott Full time

The Opportunity

This position works out of our Lake Bluff, IL (Abbott Park) location in the Transfusion Medicine Division . Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.

As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the New Product Development regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and play a consultative role by partnering across business functions. The individual may assist in identifying data needed, obtaining these data, and ensuring that they are effectively presented for the registration of products worldwide. The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation.

What You’ll Work On

Participate as the regulatory functional product team member for the organization’s Transfusion Medicine regulatory team.

Supports necessary regulatory activities required for product market entry and on-market support of transfusion systems, including instrument hardware, software and mainly assay support.

Premarket: Assess the acceptability of quality, preclinical and clinical documentation for submission filing. Compile, prepare, review, and submit regulatory submission to authorities.

Work with cross functional teams to review and approve protocols to ensure alignment with regulatory requirements.

Strategic Planning: Assist in SOP development and review. Provide regulatory input to product lifecycle planning. Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions. Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.

Understand, investigate, and evaluate regulatory history/background of class, disease/ therapeutic/diagnostic context to assess regulatory implications for approval. Determine trade issues to anticipate regulatory obstacles. Determine and communicate submission and approval requirements. Participate in risk-benefit analysis for regulatory compliance.

Compile; prepare; review and submit regulatory submission to authorities (US and International).

Monitor impact of changing regulations on submission strategies. Monitor applications under regulatory review. Monitor and submit applicable reports to regulatory authorities. Evaluate proposed preclinical, clinical, and manufacturing changes for regulatory filing strategies. Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.

Postmarket: Maintain annual licenses, registrations, listings, and patent information. Assist compliance with product postmarketing approval requirements.

Review and approve advertising and promotional items to ensure regulatory compliance. Assess external communications relative to regulations. Review regulatory aspects of contracts. Assist with label development and review for compliance before release.

Submit and review change controls to determine the level of change and consequent submission requirements. Analyze the input of cumulative product changes to current product submissions.

Contribute to the development and functioning of the crisis/ issue management program. Ensure product safety issues and product-associated events are reported to regulatory agencies. Provide regulatory input for product recalls and recall communications Job specific responsibilities may include (choose applicable areas and expand as appropriate).

Participates as a Team Member: Actively contributes to the team process, commits to team goals, expresses opinions, and shares ideas freely.

Contributes to the creation of the team's mission objectives and strategies, accepts team decisions, and works toward their implementation.

Required Qualifications

Bachelors degree in regulatory affairs preferred and may be used in lieu of direct regulatory experience, or an equivalent combination of education and work experience.

Minimum 3 years experience.

Preferred Qualifications

Masters degree

3-4 years’ experience in a regulated industry (e.g., medical products, nutritional). 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.

Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.

Regulatory history, guidelines, policies, standards, practices, requirements, and precedents.

Regulatory agency structure and processes.

Principles and requirements of applicable regulations and agency guidance.

Submission/registration types and requirements.

GxPs (GCPs, GLPs, GMPs).

Principles and requirements of promotion, advertising, and labeling.

Ethical guidelines of the regulatory profession.

Has broad knowledge of various technical alternatives and their potential impact on the business.

Exercise good and ethical judgment within policy and regulations.

Use in-depth knowledge of business functions and cross group dependencies/ relationships.

Define regulatory strategy with supervision.

Follow scientific arguments, identify regulatory scientific data needs and with supervision solve regulatory issues.

*

  • Regulatory Affairs Specialist

    4 weeks ago

    Green Oaks, Illinois, United States Abbott Full time

    The OpportunityAt Abbott, we are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team in Irving, TX or Abbott Park, IL.What You'll Work OnParticipate as the regulatory functional product team member for the organization's Transfusion Medicine regulatory team.Support necessary regulatory activities required for product market entry...

  • Regulatory Affairs Specialist

    1 month ago

    Bowling Green, Ohio, United States ITS - Integrated Talent Strategies Full time

    Regulatory Affairs SpecialistIntegrated Talent Strategies (ITS) is seeking a highly skilled Regulatory Affairs Specialist to join our team in the Perrysburg, OH area. This direct hire position offers a range of excellent benefits, including health insurance, 401(k), and paid time off.The successful candidate will assist the Regulatory Affairs department in...

  • Regulatory Affairs Senior Associate

    2 weeks ago

    thousand oaks, United States Randstad Life Sciences US Full time

    Immediate opportunity for a REMOTE Regulatory Affairs Senior Associate within the Regulatory Information Management & Systems (RIMS) team with one of the world's leading biotechnnology companies located in Thousand Oaks, CA.Schedule/Shift: 1st shift, Mon.-Fri., EST time zone preferredPosition type: 1 year contrat (through November 2025); extension...

  • Regulatory Affairs Senior Associate

    3 weeks ago

    Thousand Oaks, United States Randstad Life Sciences US Full time

    Immediate opportunity for a REMOTE Regulatory Affairs Senior Associate within the Regulatory Information Management & Systems (RIMS) team with one of the world's leading biotechnnology companies located in Thousand Oaks, CA.Schedule/Shift: 1st shift, Mon.-Fri., EST time zone preferredPosition type: 1 year contrat (through November 2025); extension...

  • Regulatory Affairs Senior Associate

    2 weeks ago

    Thousand Oaks, United States Randstad Life Sciences US Full time

    Immediate opportunity for a REMOTE Regulatory Affairs Senior Associate within the Regulatory Information Management & Systems (RIMS) team with one of the world's leading biotechnnology companies located in Thousand Oaks, CA.Schedule/Shift: 1st shift, Mon.-Fri., EST time zone preferredPosition type: 1 year contrat (through November 2025); extension...

  • Regulatory Affairs Senior Associate

    2 weeks ago

    Thousand Oaks, CA, United States Randstad Life Sciences US Full time

    Immediate opportunity for a REMOTE Regulatory Affairs Senior Associate within the Regulatory Information Management & Systems (RIMS) team with one of the world's leading biotechnnology companies located in Thousand Oaks, CA.Schedule/Shift: 1st shift, Mon.-Fri., EST time zone preferredPosition type: 1 year contrat (through November 2025); extension...

  • Regulatory Affairs Director

    4 weeks ago

    Thousand Oaks, California, United States Amgen Full time

    About the RoleAmgen is seeking a highly skilled Regulatory Affairs Director to lead the development and execution of strategy for the CMC and Device Regulatory Affairs team. This role will ensure strategic alignment across programs and geographies, representing the CMC and Device Regulatory Affairs team with Amgen leadership, governance bodies, regulatory...

  • Regulatory Affairs Director

    4 weeks ago

    Thousand Oaks, California, United States Amgen Full time

    Job SummaryAmgen is seeking a highly skilled Regulatory Affairs Director to lead the development and execution of strategy for the CMC and Device Regulatory Affairs team. This role will oversee the development of regulatory strategies, decisions, and implementation plans for the Obesity portfolio.Key ResponsibilitiesDevelop and execute regulatory strategies...

  • Regulatory Affairs Director Global CMC

    4 weeks ago

    Thousand Oaks, California, United States BioSpace, Inc. Full time

    Job SummaryAs a member of the BioSpace, Inc. team, you will play a key role in shaping the company's regulatory strategy and ensuring compliance with global regulations. The ideal candidate will have a strong background in CMC regulatory affairs and experience in leading cross-functional teams.Key ResponsibilitiesDevelop and execute CMC regulatory strategies...

  • Manager Medical Affairs

    1 month ago

    Green Oaks, United States Abbott Full time

    The Opportunity Manage within the Medical Affairs Sub-Function. Focus is on synthesizing and advancing scientific and clinical knowledge within diabetes for both internal and external stakeholders. What You'll Work On • The Medical Affairs Manager will be responsible for advancing and maintaining scientific and clinical knowledge, with a...

  • Medical Affairs Manager

    1 month ago

    Green Oaks, Illinois, United States Abbott Full time

    The OpportunityAbbott is seeking a highly skilled Medical Affairs Manager to join our team. As a key member of our Medical Affairs Sub-Function, you will be responsible for advancing and maintaining scientific and clinical knowledge within diabetes for both internal and external stakeholders.Key Responsibilities• Synthesize and advance scientific and...

  • Senior Director, Regulatory Risk Services

    4 weeks ago

    Thousand Oaks, California, United States Amgen Full time

    Job Title: Senior Director, Regulatory Risk ServicesAmgen is seeking a highly skilled Senior Director, Regulatory Risk Services to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring the quality and compliance of our products and processes.Key Responsibilities:Develop and implement regulatory strategies...

  • Senior Care Specialist

    4 weeks ago

    Thousand Oaks, California, United States Senior Helpers - Thousand Oaks Full time

    Job DescriptionSenior Helpers - Thousand Oaks is seeking a compassionate and dedicated individual to join their team as a Senior Care Specialist.As a Senior Care Specialist with Senior Helpers, you will have the opportunity to work one-on-one with clients in their own homes, providing personalized care and support to help them maintain their...

  • Senior Trademark Counsel

    1 month ago

    Green Oaks, Illinois, United States Abbott Full time

    Job Title: Senior Trademark CounselAbbott 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, nutritionals, and branded generic medicines.Job Summary:We are seeking an...

  • Validation Specialist

    4 weeks ago

    Green Oaks, Illinois, United States Blue Star Partners LLC Full time

    Job OverviewWe are seeking a highly skilled Validation Specialist to join our team at Blue Star Partners LLC.Job SummaryThe Validation Specialist will lead and support validation efforts for various projects, creating and executing validation test scripts, documenting test results, and reviewing and evaluating validation assessments.Key ResponsibilitiesLead...

  • Senior Driver Compliance Specialist

    1 month ago

    Green Bay, United States Schneider National, Inc. Full time

    Schneider is seeking a Senior Driver Compliance Specialist in Green Bay, WI to evaluate and assess whether drivers' motor vehicle reports, physicals and sleep apnea compliance information require intervention. The Senior Driver Compliance Specialist Compliance Specialist, Driver, Senior, Compliance, Specialist, Manufacturing, Technology, Motor

  • Senior Drafting Specialist

    4 weeks ago

    Sherman Oaks, California, United States Gispan Design Full time

    Job Title: Senior Drafting SpecialistWe are a design firm specializing in Residential & Commercial design, located in Sherman Oaks. Our team is currently looking for an experienced Senior Drafting Specialist to join our team.The ideal candidate will have a thorough knowledge of AutoCAD and experience in drafting plans, sections, elevations, details, etc. The...

  • LPN - Senior Care Specialist

    4 weeks ago

    Green Valley, Arizona, United States Senior Resource Group Full time

    At Senior Resource Group, we are seeking a compassionate and skilled LPN to join our team in providing exceptional care to our residents. As a Nursing Professional in our Assisted Living community, you will have the opportunity to make a meaningful difference in the lives of our residents and their families.Key Responsibilities:Provide nursing services to...

  • Senior Human Resources Specialist

    1 month ago

    Bowling Green, Kentucky, United States Kentucky Personnel Cabinet Full time

    Job Title: Senior Human Resources SpecialistJoin the Kentucky Personnel Cabinet as a Senior Human Resources Specialist and contribute to the success of our organization.Job Summary:The Senior Human Resources Specialist will be responsible for the administration of payroll, benefits, and other employee services at the Bowling Green Veterans Center.Key...

  • Senior Human Factors Engineer

    4 weeks ago

    thousand oaks, United States ACL Digital Full time

    Title: Senior Human Factors Engineer - AMAGJP00013164Locations: Remote Duration: 12 months to begin with Job Description:Supports the Instruction Design and Human Factors Engineering/Usability Engineering (HFE) teams to create instruction materials, including Instructions for Use (IFUs) used to instruct laypersons in the proper use of combination...