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    Regulatory Affairs Associate - Chicago, United States - Planet Pharma

    Planet Pharma
    Planet Pharma Chicago, United States

    1 week ago

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    Description

    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.

    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 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 support

    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 playerSelf-motivated.


    Responsible 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.
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