Regulatory Affairs Manager/Senior Manager

Regulatory Affairs Manager/Senior Manager

Glendale Heights, IL

I’m partnering exclusively with a growing pharmaceutical company looking to bring on a new Regulatory Affairs Manager who can take ownership of Clinical Regulatory, Operations and Submissions across an established portfolio of sterile injectable products.

This is an exciting opportunity to join a business entering its next phase of growth and investment, where you’ll have direct visibility with senior leadership and the opportunity to make a meaningful impact on regulatory operations and future product development.

Key responsibilities:

• Lead the preparation, review and submission of ANDAs, supplements, amendments, annual reports and other FDA regulatory filings.
• Develop and execute regulatory strategies across marketed products and new product development programmes.
• Ensure submissions meet FDA requirements, current guidance and eCTD standards, with a strong focus on quality and consistency.
• Support FDA interactions, including agency meetings, correspondence and responses to regulatory deficiencies.
• Partner cross-functionally with Quality, Manufacturing, R&D, Supply Chain and Commercial teams to support product lifecycle management.
• Provide regulatory input into new business opportunities, product expansion and portfolio development.
• Support labelling and artwork activities while helping strengthen regulatory processes and best practices.

Qualifications & Experience:

• Degree in a relevant field
• 5+ years of Regulatory Affairs experience within the pharmaceutical industry.
• Experience preparing and submitting ANDAs
• Experience with eCTD software, MSWord, Excel, Adobe Acrobat and other document processing software
• A proven track record of independently compiling and filing ANDAs and/or NDAs.
• Strong understanding of FDA regulations, cGMP requirements and eCTD submission standards.
• Experience managing FDA interactions and working collaboratively across technical and commercial functions.

This role would suit someone looking to combine hands-on regulatory submission expertise with broader ownership, senior stakeholder exposure and the opportunity to help shape regulatory strategy within a growing pharmaceutical business.