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The Regulatory, Environment, Clinical Development and Global Supply (REG) Law team consists of four teams that handle a wide variety of legal matters for Pfizer: (1) the Regulatory Law team; (2) the Clinical Development team; (3) the Global Supply team; and (4) the Environmental, Health and Safety team.
This position reports into the U.S. Regulatory Law team, with responsibility for the interpretation and implementation of key FDA-related legislation, regulations and policies. Responsibilities include counseling the business regarding the Hatch-Waxman Act and associated regulatory exclusivities, product lifecycle planning, post-marketing regulatory commitments, the generic drug review and approval process, regulatory requirements associated with product labeling/packaging/sampling, and partnering with our Regulatory and Legislative Affairs colleagues to advance initiatives important to Pfizer.
We are seeking an attorney who is interested in working in challenging, dynamic environment supporting a variety of client groups. Specific responsibilities include:
Counseling regarding the interpretation and implementation of key FDA-related legislation, regulations and guidances, with a focus on matters involving regulatory exclusivities, product lifecycle planning, post-marketing regulatory commitments, DEA/controlled substance regulations, and drug review and approvals.
Counseling Pfizer’s Essential Health business on matters relating to the review and approval of sterile injectable products and complex generic products.
Counseling Pfizer’s U.S. Trade organization regarding applicable federal and state laws and regulations, including drug supply chain security legislation, import/export matters, and drug sampling matters.
Counseling regarding FDA’s regulation of manufacturer communications and evolving communication platforms including social media and mobile medical applications
Bachelors degree and Juris Doctorate
Member of a state bar/admitted to a relevant jurisdictions
A minimum of 5-7 years of experience working in the pharmaceutical or biotech industry, or at a law firm supporting clients in the pharmaceutical or biotech industry, preferably including matters involving counseling on the interpretation of FDA-related legislation and regulations
Self-motivated and able to handle multiple demands and priorities simultaneously
Proven ability to proactively identify and analyze potential legal issues and develop creative and business focused legal advice and solutions
Proven ability to cultivate strong client relationships and successfully influence leadership in a fast paced, innovative business environment
Excellent communication and writing skills
Flexibility to travel as needed
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.
Additional Offer Details:
Last Date to Apply for Job: 10/17/17
This job is Pfizer Exempt US Grade: 16
Employee Referral Eligible
Additional Locations: Collegeville, PA, Washington D.C., and New York City
All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That's why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place.