Search Jobs
Regulatory Affairs Associate II
N Waukegan Rd North Chicago, IL 60048 US
Job Description
*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
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The 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, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
Share This Job:
Related Jobs:
About North Chicago, IL
Are you sure you want to apply for this job?
Please take a moment to verify your personal information and resume are up-to-date before you apply.