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Regulatory Affairs Associate II

North Chicago, IL 60048

Posted: 02/07/2025 Employment Type: Contract Job Category: Regulatory Affairs Job Number: 617307 Is job remote?: Hybrid Country: United States

Job Description

Target PR Range: 30-38/hr
*Depending on experience

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. 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

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

*CO/NYC candidates might not be considered

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About North Chicago, IL

Ready to take the next step in your career? Explore job opportunities in and around North Chicago, Illinois, where growth knows no bounds. Nestled along the shores of Lake Michigan, this vibrant area offers a blend of urban excitement and natural beauty. Home to iconic landmarks like Navy Pier and the Art Institute of Chicago, plus renowned theater venues like the Chicago Shakespeare Theater and iconic sports teams like the Cubs and Bulls, North Chicago boasts a rich cultural tapestry. Indulge in the local deep-dish pizza or take a stroll through Millennium Park; this region truly has something for everyone. Join us in discovering the endless possibilities for personal and professional growth in North Chicago - where careers flourish and dreams take flight.

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.