Regulatory Affairs Associate II (CMC Regulatory Strategy and Lifecycle Management)

Orion Group; North Chicago (IL); Hybrid; USD 94,558,000 - 111,751,000; Full time

Job summary

Orion Group in North Chicago, IL, is seeking a Regulatory Affairs Associate II to support CMC regulatory strategy and lifecycle management for marketed and development-stage products. You will work with internal and external partners to prepare regulatory strategies and submissions.

The role involves drafting CMC filing dossiers, managing submissions (INDs, CTAs, renewals, annual reports), and ensuring compliant documentation within a matrix environment; hybrid work is preferred.

Qualifications

• Bachelor's degree in chemistry, biology, pharmacy, pharmacology, engineering, or related discipline.
• 2-4 years of CMC regulatory experience; advanced degree preferred.
• 4 years of pharmaceutical or related industry experience.
• 1-2 years of experience in quality systems or cross-functional project management.
• Experience in a complex matrix environment.
• Strong written and verbal communication skills.

Responsibilities

• Prepare CMC regulatory filing dossiers with technical teams.
• Prepare CMC regulatory submissions including INDs/CTAs, amendments, new market applications, renewals, annual reports, supplements, and post-approval variations.
• Develop and manage content strategy for regulatory submissions.
• Assess regulatory impact of manufacturing and product changes; support change-control activities.
• Analyze information affecting regulatory decisions; seek expert advice as needed.
• Review and revise submission content to present data and strategy clearly.
• Respond to global regulatory information requests and escalate issues to management.
• Perform document management system responsibilities and maintain regulatory documentation.
• Build and maintain relationships across Regulatory Affairs, Operations, and R&D.
• Represent CMC Regulatory Affairs on product development and lifecycle-management teams.
• Stay current on regulatory procedures, legislation, and developments affecting the assigned business area.

Skills

CMC regulatory experience

Regulatory strategy

Communication skills

Education

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

Job description

Regulatory Affairs Associate II - CMC Regulatory Strategy and Lifecycle Management

Location: Hybrid Preferred - North Chicago, Illinois

Length of Assignment: 2 years

Pay Rate: 33-39/hr (depending on benefits preference and candidate location)

Job Description:

The Regulatory Affairs Associate II supports Chemistry Manufacturing and Controls regulatory activities for marketed and development-stage products. Working with internal and external partners, this role helps prepare regulatory strategies and submissions that support timely approvals and continued product availability.

• Work with technical teams to prepare CMC regulatory filing dossiers.
• Prepare CMC regulatory submissions under management supervision, including INDs and CTAs, amendments, new market applications, renewals, annual reports, supplements, and post-approval variations.
• Develop and manage content strategy for regulatory submissions under management supervision.
• Assess manufacturing and product changes for regulatory impact and support change-control activities in accordance with regulations and company policies.
• Analyze and interpret information that may affect regulatory decisions; seek expert advice and technical support as needed.
• Review and revise submission content to clearly present data and regulatory strategy to health authorities.
• Respond to global regulatory information requests under management supervision and promptly escal ta important issues to regulatory management.
• Perform document management system responsibilities and maintain accurate regulatory documentation.
• Build and maintain relationships across Regulatory Affairs, Operations, and Research and Development organizations.
• Represent CMC Regulatory Affairs on product development and lifecycle-management teams, including Global Regulatory Product Teams and Operations Brand Teams, as needed.
• Stay current on regulatory procedures, legislation, and developments affecting the assigned business area.

Qualifications:

Required Qualifications:

• Bachelor's degree in chemistry, biology, pharmacy, pharmacology, engineering, or another related discipline.
• 2-4 years of CMC regulatory experience. Relevant advanced degree preferred. Certification a plus.
• 4 years of pharmaceutical or related industry experience.
• 1-2 years of experience in quality systems or cross-functional project management.
• Experience working in a complex, matrixed environment.
• Strong written and verbal communication skills.

Preferred Qualifications:

• Relevant advanced degree or professional certification.
• 5 years of pharmaceutical experience, including 1-2 years in Regulatory Affairs or 1-2 years in Discovery, Research and Development, or Manufacturing.
• Experience supporting United States and European Union post-approval variations.
• Change-management experience and experience developing international regulatory strategies for marketed products.
• Ability to work onsite in a hybrid arrangement; in-person availability is preferred.

People are our business worldwide

Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.