28 Regulatory Affairs Associate Jobs in North Chicago, IL
ATR International, Inc. is Hiring a Regulatory Affairs Associate Near North Chicago, IL
Job Title: Regulatory Affairs Associate
Type: Contract - 8 Months
Onsite-100 Abbott Park Road, Abbott Park, IL
Pay: $32.00/hr
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 & other stakeholder to define plan & 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 & various metrics.
RESPONSIBILITIES
Major Responsibilities:
§ Support Regulatory submissions for Food, FSMP, Enteral Nutrition, IF & FUF, Drug for EURI/ MENAP/ global. Possess well developed skills in supporting development of product registration dossiers, submission, progress reports, deficiencies, amendments, etc …
§ Support teams to develop regulatory submissions strategy and update strategy based upon regulatory changes
§ Partnership 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 requirements
§ Support pulling reports, metrics related to submissions and approvals.
§ Offers country specific regulatory support
§ System VEEVA experience is helpful
Stakeholders:
§ 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, R&D, Technical center & Product Developers.
Skills/Experience Requirements
Requirements 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 & scientific aspects of nutritional products.
§ Decision Making/ Exercises judgment in selecting innovative, practical methods to achieve problem resolution. Influence stakeholders on technical solutions.
§ Adaptable in cultural and political diversity.
§ Capacity to learn and challenge status quo.
§ Team player
§ Self-motivated.
Job Summary
Contractor
Wholesale
$65k-84k (estimate)
07/04/2024
08/01/2024
atrinternational.com
MONDONVILLE, OCCITANIE
1,000 - 3,000
1988
GIOVANNI TRAMPARULLO
$200M - $500M
Wholesale
Related Companies
The job skills required for Regulatory Affairs Associate include Regulatory Affairs, Project Management, Product Registration, Change Control, etc. Having related job skills and expertise will give you an advantage when applying to be a Regulatory Affairs Associate. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Regulatory Affairs Associate. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Regulatory Affairs Associate positions, which can be used as a reference in future career path planning. As a Regulatory Affairs Associate, it can be promoted into senior positions as a Regulatory Affairs Specialist II that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Regulatory Affairs Associate. You can explore the career advancement for a Regulatory Affairs Associate below and select your interested title to get hiring information.
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