Regulatory Affairs Associate
Regulatory Affairs Associate
Intellectt Inc
Abbott, TX
See who Intellectt Inc has hired for this role
Job Title: Regulatory Affairs Associate
Location: Abbott Park, IL
Duration: 05 months
Shift Timings: 8:30 AM to 5:30 PM
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.
- Individuals shall develop partnership with other regulatory functions, affiliates & other stakeholder to define plan & strategy for submissions and any deficiencies and develop approach to solutions.
- Individuals shall be good with excel and numbers, so that they can help analyze submission numbers & various metrics.
- 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
- 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.
- Prior experience (2-3yrs) and Bachelor’s degree in nutrition/science related field.
- Good understanding and working experience in different regulatory environments in multiple countries.
- Experience in the 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.
-
Seniority level
Associate -
Employment type
Full-time -
Job function
Legal -
Industries
Staffing and Recruiting
Referrals increase your chances of interviewing at Intellectt Inc by 2x
See who you knowGet notified about new Regulatory Affairs Associate jobs in Abbott, TX.
Sign in to create job alertSimilar jobs
People also viewed
-
Criminal Defense Attorney
Criminal Defense Attorney
-
Criminal Defense Attorney
Criminal Defense Attorney
-
Litigation Defense Associate Attorney
Litigation Defense Associate Attorney
-
Experienced Legal Transcription Specialist - Independent Contractor
Experienced Legal Transcription Specialist - Independent Contractor
-
Litigation Attorney
Litigation Attorney
-
Intellectual Property Patent Prosecution Associate Attorney
Intellectual Property Patent Prosecution Associate Attorney
-
Family Law Attorney
Family Law Attorney
Similar Searches
Explore collaborative articles
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
Explore More