Regulatory Affairs Associate II

Stellent IT LLC; North Chicago (IL); Hybrid; USD 85,000 - 110,000; Full time

Job summary

Stellent IT LLC in North Chicago, IL seeks a Regulatory Affairs Associate II to support CMC regulatory submissions and strategy under management supervision. The role collaborates with cross-functional teams to prepare filings such as INDs/CTAs, amendments, and variations, ensuring compliance and timely delivery.

The candidate will work in a matrix environment, manage document control, and respond to regulatory information requests, with a focus on first-pass approvals and continuous process

Qualifications

• 2-4 years CMC Regulatory experience.
• US/EU post-approval variation support preferred.
• International Regulatory Strategy experience a plus.
• Strong oral and written communication skills.
• Experience working in a matrix environment.
• Familiarity with INDs/CTAs and variations.

Responsibilities

• Working with technical team to prepare regulatory filing dossiers
• Potentially assessing changes for regulatory impact
• Document management system responsibilities
• Attend GRPT as needed
• Attend Operations Brand Teams as needed
• Prepares CMC regulatory submissions under management supervision.
• Analyzes and interprets information impacting regulatory decisions
• Reviews and revises regulatory submissions to present data and strategy to agencies
• Responds to regulatory information requests under management supervision
• Manages products and change control under management supervision
• Represents CMC regulatory affairs on cross-functional teams when assigned
• Stays abreast of regulatory procedures and changes in the regulatory climate

Skills

Regulatory strategy

Cross-functional collaboration

Regulatory submissions

Documentation management

Problem solving

Education

Bachelor's degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject

Advanced degree preferred

Job description

Position Title: Regulatory Affairs Associate II

Work Location: North Chicago, Illinois

Assignment Duration: 2 years

Work Arrangement: Hybrid

Any visa but no H1B

Position Summary:

The Senior Associate, RA CMC works with internal and external partners in order to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals under management supervision.

Background & Context:

Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new market applications and supplements/variations under management supervision. Build and maintains relationships within the Regulatory Affairs functional areas and the Operations and Research & Development (R&D) organizations. Represents RA CMC on product development and life-cycle management teams.

Key Responsibilities:

• Working with technical team to prepare regulatory filing dossiers
• Potentially assessing changes for regulatory impact
• Document management system responsibilities
• Attend GRPT as needed
• Attend Operations Brand Teams as needed
• Prepares CMC regulatory submissions under management supervision. Prepares regulatory submissions, including new applications and amendments, renewals, annual reports, supplements, and variations under management supervision.
• Analyzes and interprets information, that impacts regulatory decisions. Seeks expert advice and technical support as required for strategies and submissions.
• Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies under management supervision.
• Responds to global regulatory information requests under management supervision and regularly informs regulatory management of important timely issues.
• Manages products and change control with an understanding of regulations and company policies and procedures under management supervision. Analyzes and approves manufacturing change requests under management supervision.
• May represent CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations brand teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions
• Stays abreast of regulatory procedures and changes in the regulatory climate. Maintains awareness of legislation and current developments within specific areas of business

Qualifications & Experience:

Bachelor s degree: Chemistry/ Biology/ Pharmacy/ Engineering/ Other Related Subject

2-4 years CMC Regulatory experience

Preferred Experience: US/ EU Post approval variation support; Change Management Experience; International Regulatory Strategy for on market products

Required Education: Bachelor s degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject

Preferred Education: Relevant advanced degree preferred. Certification a plus.

Required Experience: 4 years pharmaceutical or industry related experience. 1-2 years in quality systems or cross functional project management

Preferred Experience: 5 years pharmaceutical experience including 1-2 years in regulatory affairs or 1-2 years in Discovery, R&D, or Manufacturing

Experience working in a complex and matrix environment

Strong oral and written communication skills

Experience Level = 3-5 Years