Job Title: Specialist Regulatory Affairs

Type: Contractor role

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.

Job Type: Contract

Pay: $30.00 - $32.00 per hour

Expected hours: 40 per week

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Experience level:

• 3 years

Schedule:

• 8 hour shift
• Day shift

Education:

• Bachelor's (Preferred)

Experience:

• regulatory affairs: 3 years (Preferred)
• medical device industry: 3 years (Preferred)
• submissions: 3 years (Preferred)
• VEEVA: 3 years (Preferred)

Ability to Commute:

• North Chicago, IL 60064 (Required)

Work Location: In person