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Senior Associate, Regulatory Affairs

Application Deadline: May 31, 2020

Location: SCHAUMBURG, IL, USA

Job Summary / Overview:

We are seeking an experienced Senior Associate of Regulatory Affairs, Post Approval to drive regulatory activities post FDA approval of various original drug applications.

This person is responsible for support of postapproval regulatory affairs activities under direction of the Department Manager. This position requires an in-depth understanding of supplements submitted to FDA, strong attention to detail skills and the experience to determine the level of FDA reporting category. The position may include up to 10% travel out of state and possibly out of the country.

Key Duties & Responsibilities:

  • Manage the assigned international CMO(s) for all postapproval applications; manage all postapproval reporting and compliance activities

  • Assess changes documented in controls, check against change control documents, and determine the level and timing of reporting to the FDA

  • Assess proposed changes to manufacturing facilities, processes, and/or controlled documents as it pertains to Guidance for Industry Changes to an Approved NDA or ANDA and Sagent SOPs.

  • Manage A/NDA original and amendment filings

  • Meet all reporting and regulatory deadlines

  • Electronically assemble annual reports, field alert reports and supplemental applications

  • Write, review and compile regulatory annual reports, advertising/promotional materials, supplements and product labeling

  • Write, review and compile documents to assist external CMO partners as required (e.g., supplements, annual reports, DMF updates, labeling packages) as agreed upon with partners; and change control review/approval

  • Coordinate compilation and review of advertising/promotional material with the Marketing department

  • Draft field alert reports, work with the Quality Group and submit to the FDA

  • Conduct regulatory review of annual product review reports provided by Sagent Quality

  • Participate in regular meetings with CMO’s occasionally outside usual work hours for international CMO’s

  • Regularly communicate through email with internal and international partners

  • Handle communications directly to and from the FDA


Knowledge, Skills and Abilities:

  • In-depth understanding of various supplements to be submitted to FDA, change levels and process is required

  • In-depth understanding of FDA terminology and technology systems

  • Proven experience working with FDA reporting and assessing of change controls

  • Strong database skills

  • Ability to work under deadline pressure / rapidly shifting priorities and manage multiple projects

  • Ability to drive projects to completion with minimal guidance.

  • Ability to work independently and with a team

  • Very strong attention to detail and judgement skills

  • Time management skills and ability to meet all deadlines

  • Excellent communication skills: verbal and written

  • Ability to understand and work closely with different cultures

  • Comfort level with asking questions, making recommendations and seeking assistance as needed

  • Proven negotiation skills with internal and external stakeholders including ability to influence without direct control


Minimum and Preferred Qualifications:

  • 4 or more years of direct pharmaceutical industry experience OR solid equivalent experience working in a cGMP and/or FDA regulated environment

  • Broad career progression including experience in multiple departments in pharmaceutical, drug development and/or manufacturing industry

  • Experience with metrics and management reporting

  • Prior direct responsibility for postapproval submissions to FDA

  • Use of PC based word processing software, spreadsheets, Adobe Acrobat, including Docubridge or other database management

  • Preferred qualification: experience with advertising and promotional materials to the FDA as well as hands-on experience reviewing and approving materials including bookmarking experience

  • Preferred qualification: formal project management skills or certification

  • Preferred qualification: Regulatory publication experience using eCTD software

  • Preferred qualification: international experience


Education / Certifications:

Bachelor of Science degree in Chemistry, Biology, Pharmacy, or related science field.

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