Pfizer Global Regulatory Lead in New York, New York
Global Regulatory LeadRole Description
EMPLOYER: Pfizer Inc.
TITLE: Global Regulatory Lead
RATE OF PAY: $144,800/year
LOCATION: New York, NY
DUTIES: Develop and implement regulatory strategies aligned to clinical and commercial targets. Engage in the preparation of on-time, high-quality, regulatory submissions. Understand the unique regulatory requirements for biosimilar products for global applications such as the European Manufacturing Authorization Applications (MAA), and other key markets (e.g. Brazil, Russia, Japan) and provide guidance to program management, CMC, non-clinical and clinical team members. Resolve problems, modify procedures, and develop and interpret policy to meet evolving biosimilar product regulatory demands. Assess and advise teams on how to mitigate regulatory risks in development projects/ therapeutic area across the biosimilar portfolio. 15% domestic and international travel required.
Minimum Education: Master's degree or foreign degree equivalent in Pharmacology, Drug Regulatory Affairs, or related field.
Minimum Experience: 5 years of experience in the job offered or a related occupation.
Special Skills Requirements: 1) Three years of experience with Regulatory submissions of Biosimilar Products and Biologics; 2) Two years of experience with current legislative authority for Biosimilar User Fee Act (BsUFA) and submissions within the BsUFA framework; 3) Two years of experience in 351(k) Applications, unique biosimilar product development meeting structure (BPD meetings); 4) One year of experience using electronic Common Technical Document (eCTD) software, lifecycle management within eCTD
This job is eligible for an Employee Referral Award (as defined by the Pfizer US Corporate Employee Referral Program Policy) as found on Workday.
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 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.
Last Date to Apply for Job: October 2 2017
This job is Pfizer Exempt US/PR Grade: 15
Additional Location Information: This role is located in New York, NY; relocation is NOT provided.
This notice is provided in compliance with 20 CFR 656.10(d). Any person may provide documentary evidence bearing on the application to the Certifying Officer of the U.S. Department of Labor, Employment & Training Administration, Harris Tower, 233 Peachtree Street, Suite 410, Atlanta, Georgia 30303.
A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.