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Regulatory Affairs Associate
3 weeks ago
Planet Pharma North Chicago, United StatesAccountability / Scope: · As the professional in the Regulatory Affairs function, the individual will assist teams in the registration of products by preparing documentation needed for registration in EURI/MENAP global. · Individual shall develop partnership with other regulatory ...
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Regulatory Affairs Associate
2 days ago
Collabera North Chicago, United StatesHome · Search Jobs · Job Description · Regulatory Affairs Associate (Food Science/Nutriti · Contract: North Chicago , Illinois, US · Salary: $32.00 Per Hour · Job Code: · End Date: · Days Left: 7 days, 3 hours left · Apply · To discuss more about this job opportunity, pl ...
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Regulatory Affairs Associate
1 week ago
Collabera North Chicago, United StatesHome · Search Jobs · Job Description · Regulatory Affairs Associate (Food Science/Nutriti · Contract: North Chicago , Illinois, US · Salary: $32.00 Per Hour · Job Code: · End Date: · Days Left: 14 days, 3 hours left · Apply · To discuss more about this job opportunity, p ...
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Regulatory Affairs Associate
8 hours ago
Collabera North Chicago, United StatesHome · Search Jobs · Job Description · Regulatory Affairs Associate (Food Science/Nutriti · Contract: North Chicago , Illinois, US · Salary: $32.00 Per Hour · Job Code: 348233 · End Date: · Days Left: 27 days, 3 hours left · Apply · To discuss more about this job opportunity, pl ...
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Regulatory Affairs Specialist
4 weeks ago
GForce Life Sciences Lake Forest, United StatesRegulatory Affairs Specialist – Onsite in Lake Forest, IL · Must be able to work W2 · Summary · Our client, a Fortune-500 Medical Device Company, has requested that we find them a regulatory affairs specialist to provide support and ensure efficient and compliant business proces ...
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Regulatory Affairs Associate
1 week ago
Collabera Lake Forest, United StatesHome · Search Jobs · Job Description · Regulatory Affairs Associate · Contract: Lake Forest, Illinois, US · Salary: $30.00 Per Hour · Job Code: · End Date: · Days Left: 18 days, 3 hours left · Apply · To discuss more about this job opportunity, please reach out to Chitra ...
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Regulatory Affairs Associate
2 days ago
Collabera Lake Forest, United StatesHome · Search Jobs · Job Description · Regulatory Affairs Associate · Contract: Lake Forest, Illinois, US · Salary: $30.00 Per Hour · Job Code: · End Date: · Days Left: 10 days, 3 hours left · Apply · To discuss more about this job opportunity, please reach out to Chitra ...
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Regulatory Affair Specialist
1 week ago
Collabera Lake Forest, United StatesHome · Search Jobs · Job Description · Regulatory Affair Specialist · Contract: Lake Forest, Illinois, US · Salary: $35.00 Per Hour · Job Code: · End Date: · Days Left: 6 days, 3 hours left · Apply · Job Description: · RESPONSIBILITIES:Responsible for technical writing ...
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Regulatory Affairs Associate
1 week ago
Collabera Lake Forest, United StatesHome · Search Jobs · Job Description · Regulatory Affairs Associate · Contract: Lake Forest, Illinois, US · Salary: $30.00 Per Hour · Job Code: · End Date: · Days Left: 21 days, 3 hours left · Apply · To discuss more about this job opportunity, please reach out to Chitra ...
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Regulatory Affairs Associate
8 hours ago
Collabera Lake Forest, United StatesHome · Search Jobs · Job Description · Regulatory Affairs Associate · Contract: Lake Forest, Illinois, US · Salary: $30.00 Per Hour · Job Code: 347263 · End Date: · Days Left: 26 days, 3 hours left · Apply · To discuss more about this job opportunity, please reach out to Chitran ...
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Regulatory Affairs Associate
1 week ago
Collabera Lake Forest, United StatesHome · Search Jobs · Job Description · Regulatory Affairs Associate · Contract: Lake Forest, Illinois, US · Salary: $30.00 Per Hour · Job Code: · End Date: · Days Left: 17 days, 3 hours left · Apply · To discuss more about this job opportunity, please reach out to Chitra ...
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Regulatory Affairs Associate
1 week ago
Collabera Lake Forest, United StatesHome · Search Jobs · Job Description · Regulatory Affairs Associate · Contract: Lake Forest, Illinois, US · Salary: $30.00 Per Hour · Job Code: · End Date: · Days Left: 19 days, 3 hours left · Apply · To discuss more about this job opportunity, please reach out to Chitra ...
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Regulatory Affairs Specialist
4 weeks ago
GForce Life Sciences Lake Forest, United StatesThe position of Regulatory Affairs Specialist II is within our client's Infectious Disease business unit. In this role, you will prepare documentation for EU Technical Files and international product registrations. · TERM & START · 1-year contract starting 6/10/24 with possibi ...
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Regulatory Affairs Associate
1 week ago
Collabera North Chicago, United StatesHome · Search Jobs · Job Description · Regulatory Affairs Associate (Food Science/Nutriti · Contract: North Chicago , Illinois, US · Salary: $32.00 Per Hour · Job Code: · End Date: · Days Left: 16 days, 3 hours left · Apply · To discuss more about this job opportunity, p ...
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Regulatory Affairs Associate
1 week ago
Collabera North Chicago, United StatesHome · Search Jobs · Job Description · Regulatory Affairs Associate (Food Science/Nutriti · Contract: North Chicago , Illinois, US · Salary: $32.00 Per Hour · Job Code: · End Date: · Days Left: 12 days, 3 hours left · Apply · To discuss more about this job opportunity, p ...
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Regulatory Affairs Associate
1 week ago
Collabera North Chicago, United StatesHome · Search Jobs · Job Description · Regulatory Affairs Associate (Food Science/Nutriti · Contract: North Chicago , Illinois, US · Salary: $32.00 Per Hour · Job Code: · End Date: · Days Left: 18 days, 3 hours left · Apply · To discuss more about this job opportunity, p ...
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Specialist Regulatory Affairs
4 weeks ago
DivIHN Integration Inc North Chicago, United StatesDivIHN (pronounced "divine") is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 200 ...
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Regulatory Affairs Associate
1 week ago
Collabera North Chicago, United StatesHome · Search Jobs · Job Description · Regulatory Affairs Associate (Food Science/Nutriti · Contract: North Chicago , Illinois, US · Salary: $32.00 Per Hour · Job Code: · End Date: · Days Left: 15 days, 3 hours left · Apply · To discuss more about this job opportunity, p ...
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Regulatory Affairs Associate
1 week ago
Collabera North Chicago, United StatesHome · Search Jobs · Job Description · Regulatory Affairs Associate (Food Science/Nutriti · Contract: North Chicago , Illinois, US · Salary: $32.00 Per Hour · Job Code: · End Date: · Days Left: 17 days, 3 hours left · Apply · To discuss more about this job opportunity, p ...
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Regulatory Affairs Associate
6 days ago
Collabera North Chicago, United StatesHome · Search Jobs · Job Description · Regulatory Affairs Associate (Food Science/Nutriti · Contract: North Chicago , Illinois, US · Salary: $32.00 Per Hour · Job Code: · End Date: · Days Left: 11 days, 3 hours left · Apply · To discuss more about this job opportunity, p ...
Specialist Regulatory Affairs - North Chicago, United States - DivIHN Integration
Description
DivIHN Integration Inc North Chicago, IL (Onsite) Full-TimeDivIHN (pronounced divine) is a CMMI ML3-certified Technology and Talent solutions firm.Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations.
Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.
Visit us atDivIHN (pronounced divine) is a CMMI ML3-certified Technology and Talent solutions firm.Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations.
Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.
Visit us atto learn more and view our open positions.Please apply or call one of us to learn moreFor further inquiries regarding the following opportunity, please contact one of our Talent SpecialistsMeghna at Rashi at Title:
Specialist Regulatory AffairsDuration: 7 MonthsLocation: Abbott Park, IL/ Columbu, OHDescriptionResponsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).Review/approval of engineering study protocols/reports and validation study protocols/reports.
Review and approval of manufacturing changes for Class III implantable medical devices.May require an advanced degree and 5-8 years of direct experience in the field.
Recent experience with Class III implantable medical devices; Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations.
Relies on extensive experience and judgment to plan and accomplish goals.Performs a variety of tasks. May lead and direct the work of others. A wide degree of creativity and latitude is expected.
Typically reports to a manager or head of a unit/department.
Accountability / Scope:
As the professional in the Regulatory Affairs function, the individual will assist teams in the registration of products by preparing documentation needed for registration in EURI/MENAP global.
Individual shall develop partnership with other regulatory functions, affiliates and other stakeholder to define plan and strategy for submissions and any deficiencies and develop approach to solutions.
Individual shall be good with excel and numbers, so that they can help analyze submission numbers and various metrics.RESPONSIBILITIESMajor Responsibilities:
Support Regulatory submissions for Food, FSMP, Enteral Nutrition, IF and FUF, Drug for EURI/ MENAP/ global.
Possess well developed skills in supporting development of product registration dossiers, submission, progress reports, deficiencies, amendments, etcSupport teams to develop regulatory submissions strategy and update strategy based upon regulatory changesPartnership with affiliates to support regulatory agency interactions to expedite approval of pending registration.
Participates/ Awareness on project plans, regulatory submission strategy, any risks management.Advises project teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.
Partner with other regulatory functions for smooth project transition and launch.
Support review of change controls to determine the level of change and consequent submission requirementsSupport pulling reports, metrics related to submissions and approvals.
Offers country specific regulatory supportStakeholders:
Direct interaction with RA functions including Regulatory Operations, Submissions Execution, Regulatory Project Management, Strategic Area and other stakeholders such as Project managers, Manufacturing Plants, affiliates, RandD, Technical center and Product Developers
Skills/Experience RequirementsRequirements include:
Prior experience (2-3yrs) and Bachelor's degree in nutrition/science related field.
Good understanding and working experience in different regulatory environment in multiple countries.
Experience in registration filing process of new nutrition products preferred.
Knowledge and understanding of formulation and scientific aspects of nutritional products.
Decision Making/ Exercises judgment in selecting innovative, practical methods to achieve problem resolution.
Influence stakeholders on technical solutions.3-5 years of regulatory exp, nutrition, healthcare, pharma exp or background, FMCG preferred, submission exp, system exp, Regulatory policies, operations exp, industry exp.
Flexible for any regulatory exp but preferred is operations regulatory, building doc, building product docs.Day-to-day dutiesWill work with a team, preparing docs, initially, they will be trained, and pull documents and reports from the system, documentation, it is an execution role, mostly depending on documentation, system experience, and regulations.
Adaptable in cultural and political diversity.Capacity to learn and challenge status quo.
Team playerSelf-motivated.
EducationLowest level BS with some years of experienceHighest level- MS or PhD with 2 years experienceInterview : 1 round, virtual
About us:
DivIHN , the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond.
DivIHN is an equal opportunity employer.
DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.
Regulatory, FDA, Randamp;amp;D Recommended Skills Consumer Packaged GoodsCreativityDecision MakingFilingLabelingMedical MaterialHelp us improve CareerBuilder by providing feedback about this job:Job ID:
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