Senior Associate, RA CMC

Planet Pharma; North Chicago (IL); On-site; USD 39,000 - 52,000; Full time

Job summary

Planet Pharma seeks a Senior Associate, RA CMC to collaborate with internal and external partners to deliver regulatory submissions and lifecycle management. The role focuses on preparing CMC strategies for INDs/CTAs and amendments, managing content for submissions under supervision, and staying aligned with product development teams.

Requires a Bachelor’s degree in a related field, 4 years of pharma experience, and strong communication skills. CO/ NYC candidates might not be considered.

Qualifications

• Bachelor's degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject.
• Advanced degree preferred.

Responsibilities

• Prepare CMC regulatory submissions and document management.
• Develop regulatory strategies to support first-pass approvals under supervision.
• Collaborate with internal and external partners for dossiers and regulatory queries.

Education

Bachelor's degree

Advanced degree

Job description

Target PR Range: 28-37.50/hr
*Depending on experience

Job Duties

• 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

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

Experience Level = 3-5 Years

*CO/NYC candidates might not be considered