Immediate opportunity for a Sr. Regulatory Affairs Associate, CMC to assist the technical team in preparing regulatory filing dossiers, assess changes for regulatory impact, and manage documentation systems. You will participate in Global Regulatory Product Team (GRPT) and Operations Brand Team meetings as needed.
As a Senior Associate, RA CMC, you will work with internal and external partners in order to deliver products to patients. Prepare CMC regulatory strategies that enable first pass approvals under management supervision. Develop and manage 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.
location: North Chicago, Illinois
job type: Contract
salary: $35.00 - 41.49 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Prepare CMC regulatory submissions under management supervision. Prepares regulatory submissions, including new applications and amendments, renewals, annual reports, supplements, and variations under management supervision.
- Analyze and interprets information, that impacts regulatory decisions. Seeks expert advice and technical support as required for strategies and submissions.
- Review and revises regulatory submissions to effectively present data and strategy to regulatory agencies under management supervision.
- Respond to global regulatory information requests under management supervision and regularly informs regulatory management of important timely issues.
- Manage 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.
- Stay abreast of regulatory procedures and changes in the regulatory climate. Maintain awareness of legislation and current developments within specific area of business
qualifications:
- Bachelor's degree (BA / BS) in Pharmacy, Biology, Chemistry, Pharmacology, Engineering or related subject
- Four (4) or more years pharmaceutical or industry related experience.
- One (1) - two (2) years in quality systems or cross functional project management
- Experience working in a complex and matrix environment
- Strong oral and written communication skills
- Advanced degree preferred. Certification a plus.
- Five (5) years pharmaceutical experience including 1-2 years in regulatory affairs or 1-2 years in Discovery, R&D, or Manufacturing
skills: CMC, Regulatory Affairs Operations, Regulatory Briefing Documents, Submissions, ICH Regulations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
