Sr. Associate Regulatory Affairs - Combination Product

Lake Forest, Illinois
November 24 2020
Position Type
Full Time
Organization Type
Role Summary and Responsibilities
  • Provides regulatory affairs support by preparing labeling and supplements for FDA drug dossiers for new product presentations or lifecycle changes. May be part of a DHF remediation project team. Will be a team member for some project teams; once proficient will take the lead role. Will have a mentor/manager for support.
  • Provides regulatory advice and support to assigned products/teams. Identifies and communicates regulatory needs and strategies, considering both drug and device regulations. Maintains awareness of applicable regulations.
  • Prepares pharmaceutical submission supplements that meet FDA regulatory requirements and guidelines. Represents Regulatory Affairs at meetings and presents agreed upon regulatory positions.
  • PROBLEM SOLVING: Reviews critical documents and determines applicability and acceptability for regulatory submission, seeking guidance when necessary. Understands the content of the submission information and is able to ensure consistency within and between dossiers as appropriate. Able to follow scientific arguments and ensure data is complete and sound. Works independently with other functional areas to obtain all information required for change requests and submissions. Interprets regulations and assure regulatory compliance. Exercises good judgment within policy and regulations. Must be able to easily deal with complexity, uncertainty, and large bodies of work.
  • ACCOUNTABILITY: Responsible for tracking and completion of assigned activities for a broad portfolio of molecules and devices. Accountable for accuracy of work and meeting multiple, simultaneous deadlines. Missed registration deadlines or inaccurate registration packages can result in missed sales or regulatory action letters. Follows scientific arguments, identifies regulatory scientific data needs and with supervision solves regulatory issues. · Presents scientific data effectively orally and in writing in a logical and persuasive manner.
  • AUTHORITY TO ACT: · Independently prepares regulatory documentation for submission to FDA. Acts independently on all routine issues, makes judgments and executes.
  • Physical or Mental Requirements: Must have critical thinking skills, excellent writing skills, strong scientific skills, good interpersonal communication skills. Must be able to adroitly adapt to constantly changing expectations and want to and be able to learn very quickly, then apply those learnings to project programs.

  • Bachelor's degree in pharmacy, nursing, biology, chemistry, pharmacology, engineering or a related subject; is required.
  • 5 years of experience in regulatory affairs in Medical Devices or Combination Products

  • Master's degree is preferred. A Ph.D. is highly preferred.

  • Eligible for Employee Referral Bonus: Yes
  • Additional Location Information: Lake Forest, IL or Kalamazoo, MI
  • Eligible for Relocation Package


Sunshine Act

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EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Regulatory Affairs

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