AddressDescription
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 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
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 (23yrs) 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
- Selfmotivated.
Job Type:
Contract
Pay:
Up to $35.00 per hour
Schedule:
- 8 hour shift
Education:
- Bachelor's (required)
Experience:
- Nutrition: 2 years (required)
Work Location:
On the road
