Regulatory Manager

Pfizer Inc.

Novi Beograd, Serbia

Job posting number: #7237135 (Ref:pf-4910276)

Posted: April 18, 2024

Job Description

Why Patients Need You

We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines.

What You Will Achieve

You will help us in preparation, publication, tracking and quality control of our submissions to the regulators in compliance with document management standards. You will be responsible for activities related to enterprise-wide regulatory management systems, including systems coordination, training others, developing and implementing plans, and providing input to systems designs.

As a Manager, you provide guidance to operational teams for managing projects. Your planning skills will help in preparing forecasts for resource requirements, and providing areas of improvement for products, processes or services. Through your comprehensive knowledge of principles and concepts in the area of regulatory affairs, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate agreements between different teams.

It is your problem-solving ability and can- do attitude that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

  • Provide guidance, lead/co-lead projects, manage own time to meet objectives, and plan resource requirements for projects across the division.
  • Review regulatory commitments, strategy decisions, meeting strategies with regulatory authorities and changes to resource allocations with Manager prior to execution.
  • Act as a point person for regulatory agency interactions including preparation of briefing packages and strategy for meetings, inspections, advisory committee meetings, and responses to agency letters pertaining to the assigned products/teams.
  • Understand and can challenge scientific arguments, identifies regulatory scientific data needs and solves regulatory issues.
  • Influence the development of new global products and improvements to existing products, which can increase sales and/or reduce compliance risk.
  • Manage registrations of existing customer products in compliance with applicable regulations.
  • Support and lead global team efforts to ensure high quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines.
  • Independently provides daily regulatory support to new Global Product Development teams and for maintenance of commercial products.
  • Provides an interface to Regulatory and Global Product Development (GPD) partners within designated Business Units, offering project leadership and expertise in the logistics involved with execution of regulatory Clinical Trial Application (CTA) submissions to regional partners and selected Health Authorities.
  • Manage the compilation for core package build, contributing to CTA and authoring documentation.
  • Manage the preparation of registration packages and responses to deficiency letters.
  • Suggest and implement system improvements to reduce cycle time and increase efficiency.

Qualifications

Must-Have

  • Pharmacist Master Degree
  • 5+ years of demonstrated experience in regulatory affairs, research and development or quality assurance/compliance
  • Demonstrated experience in the pharmaceutical industry or relevant medical device experience as needed for the position
  • Experience working directly with regulatory agencies
  • Strong knowledge of the drug development process, regulatory affairs, CTA and submissions management
  • Experience with lifecycle management of approved applications
  • Sound knowledge of applicable portions of agency guidance documents and regulations
  • Exercises good judgment within company policy and health authority regulations with good negotiation skills
  • Excellent written and interpersonal communication skills
  • Good proficiency in English. Serbian native speaker.

Adherence to Pfizer’s Values: Courage, Excellence, Integrity, Joy

Other informations:

Contract Type: permanent contract

Work Location: Novi Beograd

Availability to work 2/3 days from office

Please send resume in English

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Regulatory Affairs

#LI-PFE


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.


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More Info

Job posting number:#7237135 (Ref:pf-4910276)
Application Deadline:Open Until Filled
Employer Location:Pfizer Inc.
New York,New York
United States
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