Regulatory Affairs Associate

Client Park IL

5 MONTHS

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 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 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.