Manager, Regulatory Affairs
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 represent Pfizer as an approval liaison in the regulatory affairs team. You will play the critical role of providing strategic product direction to teams while interacting with regulatory agencies and negotiating with them to expedite approval of pending registrations. Due to your expertise, you will be the responsible for the US regulatory strategy throughout the product lifecycle and a regulatory representative to marketing or project teams and government regulatory agencies. Your understanding of regulatory procedures will help in development of submission of product registration, supplements, amendments, annual reports and periodic experience reports.
As a Manager, you provide guidance to operational teams for managing projects. Your planning skills will help in submission planning, and providing areas of improvement for products, processes or services. Through your comprehensive knowledge of principles, concepts and theories of the discipline, 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 dedication that will help in making Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
- Assembles, prepares and/or reviews and submits original registrations, amendments, supplements, maintenance reports and other documents to the United States Food and Drug Administration in line with regulatory requirements and guidelines.
- Prepares responses to action letters and other agency requests.
- Provides regulatory advice to projects/teams.
- Identifies and communicates registration needs and strategies.
- Evaluates manufacturing, procurement, compendial, and labeling changes for regulatory impact and accurately describes these changes for ease of regulatory agency review.
- Maintains awareness of applicable regulations.
- Serves as a liaison with regulatory agencies pertaining to assigned products/teams.
- Preparation of Agency meeting packages and strategies for agency meetings.
- Liaise with and provide input/direction to Global Chemistry Manufacturing and Controls, and any other key stakeholder to ensure the filing strategies for initial registrations and the lifecycle submissions are defined and executed and the FDA requirements are met, ensuring a submission ready dossier.
- Work in collaboration across the organization with stakeholders to deliver efficiencies in regulatory submissions and processes.
- Bachelor’s Degree in biology, chemistry, pharmacy, pharmacology, engineering or related subject matter.
- 3+ years of experience in regulatory affairs.
- 5+ years of experience in the pharmaceutical industry with combined experience in regulatory affairs, quality assurance/compliance, research and development or related area.
- Regulatory experience including knowledge of New Drug Application (NDA)/Abbreviated New Drug Application (ANDA) submission processes.
- Leadership qualities and management skills, team oriented with problem solving skills.
- Strong written and verbal communication and interpersonal skills.
- In depth knowledge of U.S. regulatory legislation and guidelines.
- Master’s degree
- Scientific background via formal education and/or previous work experience
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Potential travel: 5%
- Hours may need to be adjusted to accommodate overlap with global partners.
Other Job Details:
- Last Date to Apply for Job: December 15, 2020
- Eligible for Employee Referral Bonus: YES
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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.
Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.
Learn more here
Job posted: 2020-12-16