Senior Associate CMC Regulatory Affairs

Location: North Chicago IL, 60064 - Hybrid. Duration: 24 months Contract (++ possibility of extension based on performance and business needs).

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 strategies that enable first pass approvals under management supervision
• Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new market applications and supplements/variations under management supervision
• Builds 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
• 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 area of business

Requirements

• Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject
• 4 years pharmaceutical or industry related experience
• 1-2 years in quality systems or cross functional project management
• 2-4 years CMC Regulatory experience
• Experience working in a complex and matrix environment
• Strong oral and written communication skills
• Experience Level = 3-5 Years
• Must Have Bachelor's Degree: Chemistry/ Biology/ Pharmacy/ Engineering/ Other Related Subject
• Remote, in person preferred

Qualifications

• Relevant advanced degree preferred
• Certification a plus
• 5 years pharmaceutical experience including 1-2 years in regulatory affairs or 1-2 years in Discovery, R&D, or Manufacturing
• US/ EU Post approval variation support
• Change Management Experience
• International Regulatory Strategy for on market products

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• 401(k) retirement plan
• Life insurance
• Long-term disability insurance
• Short-term disability insurance
• Paid parking/public transportation
• Paid time
• Paid sick and safe time
• Hours of paid vacation time
• Weeks of paid parental leave
• Paid holidays annually

Pay

$30.00 - $40.00 Per Hour