Regulatory Operations - Professional Development Associate

The position has been designed to provide entry-level experience in key regulatory operations disciplines within Worldwide Regulatory including Dossier Publishing, and marketed product license support activities, Regulatory Submissions Management, Product Labelling Management, and US Advertising and Promotions.

The successful candidate(s) will rotate through a two-year, full-time program designed to provide a breadth of regulatory exposure across the Regulatory Operations spectrum and across Pfizer's innovative and essential health portfolios, before accepting a position in a specific discipline aligned to business and candidate needs.

The successful candidate(s) can be based out of Groton CT, New York, or Collegeville, PA facilities.

JOB RESPONSIBILITIES

Indicate the primary responsibilities critical to the job.

• Working under the oversight of a sponsoring WROLT member, and an assigned departmental workload manager, the successful candidate will collaborate to undertake the following responsibilities for Product License Support, Global Submission Management, Global Labeling Management and Advertising & Promotion support;
• As a Product License Support Manager, the candidate will ensure Pfizer maintains compliance by delivering the portfolio of one or multiple applicable regulatory obligations. Once a New Drug Application is approved, a host of activities are required to set up and maintain the new drug label and essential product information (known as drug listing data) to Pfizer's website and FDA, the National Library of Medicine (Daily Med) Website and the Drug Registration and Listing System team. Compliance activities continue with coordination of information in support of New Drug Application Annual Reports and NDA Periodic Reports. In addition, in support of EEA markets, team members will be accountable for partnering with appropriate vendors in submission of A57 records to the EMA . Team responsibilities also include managing the coordination of regulatory ancillary documents (including legalization) and drug samples to support registration and approval products in International markets.
• As a Submission Manager, the candidate is accountable for working with contributing business lines to lead operational submissions execution for designated major assets. They may operate as regulatory operational Subject Matter Expert for a Major asset and drive submission teams towards the timely delivery of globally compliant submission-ready components. The candidate may be assigned globally or regionally to meet business demands. In this capacity, they may operate as Subject Matter Expert for a selected geography.
• As a support to the Global Labelling function, the candidate will support the initial creation and relevant updates to labeling documents for specific products. This includes working with team members and mentors to maintain Core Data Sheets (CDS), United States Package Inserts (USPI), and Summary of Product Characteristics (SPC) for products registered in the EU via the Centralized, Mutual Recognition or Decentralized Procedures, as well as corresponding Patient Labeling Documents. This will also include learning relevant labeling policies and regulatory guidances on content and format and if applicable, advising team members on internal Pfizer labeling policies and procedures.
• Whilst supporting the Advertising and Promotion function, the candidate will learn the requirements for providing strategic review of US advertising and promotion materials in order to meet the US brand team's objectives while ensuring the necessary level of regulatory compliance. This will include understanding business compliance and implementation required to ensure adherence to regulatory standards, regulatory review of any internal and external business communications. This may also include gaining familiarity with the regulatory landscape through education on the Office of Prescription Drug Promotion (OPDP) and trade associations as appropriate.

• Whilst working within any of the disciplines, the candidate may be asked to be a key driver of continuous business improvement. Specific activities may include acting upon and delivering against WSR strategy through defining, participating in, and/or leading non drug specific projects, partnering across the organization, acting as a change agent to define and meet evolving external and internal business needs.

QUALIFICATIONS / SKILLS

• PhD and or PharmD graduates is a must.
• 0-3 years of experience.
• MS office proficient.
• Scientific background via formal education and work experience.
• Strong communication and interpersonal skills.
• Demonstrated ability to network in a large organization.
• Demonstrated leadership through extracurricular activities and work experience.
• Understanding of the concepts around regulatory affairs.
• Articulate with strong analytical and interpersonal skills.
• Proven aptitude in project management and process redesign.
• Proven ability to work successfully on different functions/teams.

PHYSICAL/MENTAL REQUIREMENTS

None

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

None

Last Date to Apply for Job: June 15th, 2021

Eligible for Relocation Package: NO

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.

Regulatory Affairs