Pfizer Sr. Manager, Regulatory Affairs in Madison, New Jersey
This role is responsible for Regulatory Affairs activities for Pfizer Consumer Healthcare products in the US, particularly our Dietary Supplement portfolio, which includes brands such as Centrum and Emergen-C.
Represent Regulatory Affairs on cross-functional project teams. Develop collaborative partnerships with Commercial colleagues to drive business objectives and growth.
Review and approve labeling, advertising and promotional copy, as well as creation, review and approval of label text.
Perform regulatory due diligence and develop regulatory strategies for US Dietary Supplement products.
Develop regulatory options, associated risk assessments, and recommendations regarding registration pathways, labeling and claims.
Monitor, analyze and advise the Consumer business on existing and emerging trends and requirements.
Create and develop submissions to FDA (New Dietary Ingredient, GRAS affirmation, 30-Day notifications, etc)
Represent PCH business to external parties, where necessary.
Bachelor's degree is required, preferably in a life science related major.
Minimum 8 years of regulatory experience in the pharmaceutical industry, with specific experience in the Dietary Supplement/Food regulatory environment
A thorough understanding of FDA regulations, in particular DSHEA required.
Understanding of GXP practices, including regulatory documentation quality processes.
Experience working in a highly matrixed, global and multi-site environment.
Able to handle multiple projects and exercise good judgment in prioritizing tasks.
Demonstrate the ability to research and analyze information and develop regulatory strategies.
Demonstrate the ability to work independently and within a group setting, and to interact effectively with various functional groups.
Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems.
Advanced degrees in a Life Science or RAPS certification
10+ years' experience in Dietary Supplement/Food regulatory environment
Strong computer skills and ease of adapting to new electronic systems.
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.
Other Job Details:
Last Date to Apply for Job: April 25, 2018
Additional Location Information: Can be based out of Madison, NJ or Richmond, VA.
Eligible for Employee Referral Bonus
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.