Our client, a leading pharmaceutical company, is looking for a Senior Manager to join their Regulatory Affairs team in Chicago.
13th January, 2020
Job Description & Synthesis
Oversees and drives the development and submission of regulatory filings. Manages day-to-day activities related to organization and submission of regulatory documents directly to the Food and Drug Administration (FDA). The Regulatory Senior Manager handles regulatory development and post-approval/regulatory compliance for assigned products. Manages relevant regulatory strategy components and interactions with Regulatory Authorities for these products. May perform due diligence efforts on new product opportunities.
Provides strong leadership in managing regulatory specialists and associates in the preparation, compilation, and submission of high-quality submissions (originals, amendments, supplements, and annual reports) for ANDAs, NDAs, control documents, etc. to FDA authorities.
Participates in the development of regulatory strategy and implementation plans, and ensures that these plans are executed and satisfy regulatory requirements.
Review and evaluate scientific data and reports required for regulatory submissions for consistency to relevant FDA/ICH CMC guidelines.
Evaluate change controls and provide accurate regulatory filing assessments in accordance to guidance documents.
Interact with Research & Development, Quality Assurance/Quality Control (QA/QC), and Production for gathering data and documentation for submissions.
Ensure regulatory compliance with pre-and post-approval filing and reporting requirements.
Manage specialist/associates career development and performance.
Develop a product regulatory timeline aligned to the business unit's product development, with key regulatory milestone, and activities for agency filing
Coordinate with the Labeling Lead for the development/maintenance of product labels
Ensure labeling content and product documentation is developed in accordance with regulatory requirements
Bachelor’s degree in Chemistry or Biological Sciences.
A minimum of 10+ years’ experience in the generic pharmaceutical industry including 5 years of direct experience in Regulatory Affairs.
Ability to approach issues from a strategic perspective and stay focused on the big picture. This includes the ability to develop and translate strategy into actionable objectives to effectively drive the team.
A strong scientific background with extensive experience in pharmaceutical regulatory affairs.
Capable of interacting with technical groups and understanding complex issues.
Comfortable working in a multi-culture global and matrix environment, exercising a positive influence on cross-functional teams, and motivating stakeholders to take initiative.
Ability to interpret Regulatory Authority policies and guidance and correctly apply them as appropriate in product development and labeling regulatory activities.
Ability to influence and partner with cross-functional teams in a global pharmaceutical organization
Ability to take innovative ideas from proof of concept to promote a successful product regulatory strategy and increase probability of regulatory approval
Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data
Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks.
Proven ability to drive high-performance teams.
Strong leadership and interpersonal skills, sound judgment, strong analytical skills, and excellent written and verbal communication skills.