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Senior Associate, Global Regulatory Strategy for Oncology

3 months ago

New York, New York, United States Pfizer Full time

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 regulatory liaison on the project team throughout the product lifecycle and a regulatory representative to marketing or research project teams and government regulatory agencies. Your understanding of regulatory procedures will help in development of submission of product registration, progress reports, supplements, amendments and periodic experience reports.

As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. This is a multifaceted role that will offer you a number of opportunities to enhance your skills. Your focus and ability to meet the team's targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.

It is your hard work and dedication that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

  • Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
  • Provide input to the relevant stakeholders for the development of products in-line with business objectives, ensuring strategies are adequately reflected in relevant country plans {e.g., business development or manufacturing supply) & alignment is achieved between regulatory activities and relevant country business/commercial plans.
  • Support Regulatory Affairs group development and maintain internal regulatory databases, tracking and document management systems.
  • Provide regulatory inputs for the approval of promotional materials following applicable regulatory requirement, Pfizer policies, procedures, and practices.
  • Review technical supportive information for submission to support change.
  • Ensure compliance and consistency of product labels with local requirements.
  • Represent the regulatory team at cross-functional team meetings, where required.
  • Escalate any issues or concerns within the functional line and/or relevant leadership for adjudication.
  • Ensure assigned projects of manufacturing/packaging site are approved on agreed timeline and closely communicate with site/Logistics to ensure smooth of supply.
  • Oversee and manage the completion of clinical trial applications.
  • Supports Query and commitment management in collaboration relevant stakeholders.
  • Maintain licenses in compliance with local regulations by ensuring that corporate regulatory processes, Standard Operating Procedures (SOPs) and systems are in place, and that staff are trained in these systems and procedures.

Qualifications

Must-Have

  • Bachelor's Degree
  • 3+ years of demonstrated experience in regulatory affairs or in a regulated industry
  • Proven ability to manage complex regulatory issues and consistently deliver to time and quality standards
  • In-depth knowledge of the current health regulatory framework for drug regulatory procedures
  • Problem solving skills, strong detail, quality and compliance orientation
  • Good verbal and written communication skills and fluent in English
  • Proficient computer skills, e.g. MS Office, MS Outlook, Internet, database use

Nice-to-Have

  • Master's degree
  • Relevant pharmaceutical experience
  • Strategic thinking with good project management skills

Work Location Assignment:Flexible

The annual base salary for this position ranges from $74,900.00 to $124, In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 7.5% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | ). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

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. This position requires permanent work authorization in the United States.

Regulatory Affairs