Regulatory Affairs Analyst II

Nature and Scope

This position, reporting to the Regulatory Affairs Supervisor, supports the activities of the Regulatory Affairs department with emphasis on CMC submission elements.

Essential Duties and Responsibilities

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

* Lead the authoring and eCTD compilation of Original, Lifecycle and Compliance related FDA regulatory submissions under direction of senior RA personnel

* Author and peer review regulatory submissions in accordance with applicable ICH, CFR, and FDA guidance within specified timelines. This would include but not be limited to NDA, ANDA, PAS, CBE, Annual report and Complete Response/Information Request submissions.

* Compile high-quality submissions in eCTD format and execute peer review for compliance with applicable regulations and FDA guidance employing use of submission publishing tools and software

* Lead meetings and interact with members of the project team and sub-teams to drive submission timelines and determine risks to filing, escalating to management when appropriate

* Review and approve proposed changes to established regulatory conditions to ensure compliance with FDA guidelines and to maintain adequate control and flexibility for the lifecycle management of the commercial product portfolio under direction of senior Regulatory Affairs personnel

* Identify and implement process improvements, author and/or review assigned SOPs, protocols, technical documents and stability reports to ensure suitability for regulatory filing under direction of senior RA personnel

* Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

* Bachelor's Degree in a life science or other related field required

* Minimum 3 Years in the pharmaceutical industry required

* Minimum 1 Year experience with regulatory submissions required

* Experience with sterile generics and NDAs preferred

* Problem solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision; Advanced proficiency.

* Microsoft Office systems; Intermediate proficiency.

* Must be able to work well in a team environment with strong attention to detail; Advanced proficiency. Strong organizational, interpersonal and communication skills (oral and written).

* Organizational, interpersonal and communication skills (oral and written); Advanced proficiency.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

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