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This position will be responsible for independently advising on several key substantive areas within the Regulatory, Environmental and Global Supply Law (REG Law) group, reporting directly to the Assistant General Counsel, US Regulatory – GxP Regulatory Counsel. This individual will provide legal advice and assistance to clients in Pfizer’s manufacturing group (Pfizer Global Supply - PGS) on matters involving regulatory compliance relating to manufacturing operations, including support for FDA and other board of health inspections, and quality matters that could involve market action. This individual will also provide legal advice and assistance for clients on other areas of regulatory law as applicable, with a primary focus on GxP regulatory counseling. This position will also provide legal support for other members of REG Law to support regulatory counseling on strategic, policy and compliance matters, including adverse drug experience reporting and good clinical practices. This position will have primary responsibility for advising on regulatory compliance matters in connection with (1) software medical devices; (2) medical devices; (3) combination products; and (4) adverse drug experience reporting for customer engagement programs and customer interaction tracking tools and will support AGC as necessary by participating in governance committees with senior level operations and quality leaders in the relevant businesses.
Accountable for providing independent advice and support to Pfizer Global Supply – Quality Operations, Worldwide Regulatory Strategy, Medical Quality Assurance (MQA), Worldwide Pharmacovigilance, Safety and Regulatory Compliance (SRC) and Pharmaceutical Sciences Quality Assurance, including:
Advise PGS Quality Operations on matters relating to GMP and other applicable regulatory requirements, including review of Field Alert Reports, Medical Device Reports and other regulatory notifications; support FDA GMP inspections and review and provide legal advice on 483 responses; participate in AQRTs, coordinating with other members of REG Law as appropriate; and counsel PGS in preparation for meetings with FDA and other regulators on GMP remediation and drug shortage matters. Serve as primary legal support for regulatory compliance matters in connection with software medical devices, medical devices, and combination products.
Advise MQA, SRC, Pharmacovigilance and other functions on relevant aspects of FDA regulatory law, with a focus on compliance with Good Clinical Practice for sponsor inspections and policies and inspections relating to adverse drug experience reporting. Serve as primary legal support for regulatory compliance matters in connection with adverse drug experience reporting for customer engagement programs and customer interaction tracking tools.
Coordinate with other members of REG Law and advise Regulatory Affairs on filing strategy and regulatory compliance on ANDA, 505(b)(2) and biosimilar applications, coordinating as necessary with the International Regulatory Law and Medical Affairs and Policy teams.
Advise Pharmaceutical Sciences on GxP regulatory law issues.
Provide regulatory law advice as necessary to support business development activity.
Bachelor’s Degree and Juris Doctorate.
Member of a State Bar/ Admitted as an attorney in relevant jurisdiction.
10 plus years post qualification experience in a law firm, in-house legal division or federal regulatory agency, preferably in the pharmaceutical or biotech industry, including matters related to FDA regulatory compliance and inspection support in the regulatory, manufacturing, pharmacovigilance and clinical practice areas.
Knowledge and expertise in clinical and postmarketing adverse drug experience reporting, postmarketing regulatory commitments and GxP regulations, including extensive experience reviewing and drafting 483 responses.
Experience developing regulatory strategy and regulatory communications relating to regulatory compliance matters.
Flexibility to travel as needed.
Collaborate, influence and work across as well as participate in matrix teams.
Detail oriented and able to set and manage multiple priorities whilst advising on multiple matters at the same time.
Self-motivated and able to perform role independently, with a minimum level of supervision.
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 climate.
Ability to interact and collaborate autonomously with business clients and other stakeholders at all levels and capacities across the organization (ex. Audit, Compliance, Finance, HR, Security).
Ability to select and manage outside counsel, meet budget and financial goals for work associated with outside counsel and other third party providers.
Ability and willingness to:
Gain deep understanding of business strategies and actively counsel on business and legal strategies and opportunities
Devise and deliver tailored education programs to key client groups on a range of legal, policy and compliance matters
Actively anticipate, develop and advocate positions on important compliance and quality matters impacting business objectives.
Track record of accountability and sound judgment - to take ownership of an issue and provide concise and timely advice.
Strong leadership skills and innovative thinker.
Demonstrated ability to manage work in a matrix team.
Commitment to continuing to build ownership culture for REG Law team and fulfilling and modeling the Legal Division Commitments to our colleagues and our clients.
Last Date to apply for job : August 28, 2017
Employee Referral Bonus Eligible
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.
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INTERESTED APPLICANTS PLEASE APPLY AT PFIZERCAREERS.COM. ONLY APPLICATIONS RECEIVED AT PFIZERCAREERS.COM WILL BE CONSIDERED. SEARCH FOR REQ#1607131.
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 biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.