Head Regulatory Switch Job in Madison, New Jersey US

Head Regulatory Switch

Org Marketing Statement Pfizer Inc: Working together for a healthier world Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide. Job Focus The Pfizer Consumer Healthcare (PCH) Regulatory Switch Head will provide regulatory leadership and strategic direction for the RD Rx to OTC switch teams in support of internal and external Rx to OTC Switch candidates. The Regulatory Switch Head will interface with other functional members of the Rx to OTC switch project teams (e.g. RD Switch Category lead, Commercial, Clinical/Medical Affairs/Safety) to ensure flawless design and execution of regulatory switch strategies in major markets (eg US, EU). Organizational Relationships: " The Regulatory Switch Head for PCH will be a direct report to Vice President, Worldwide Regulatory Strategy for PCH " Leader of Switch Regulatory Affairs Sub-team through matrix leadership Leader of Regional Medical and/or Technical teams with PCH Medical and/or Technical members as direct reports " Member of PCH WRS Regulatory Leadership Team Resources Managed (budget and FTEs): " Matrix management as team leader for 4-6 regulatory affairs members of Switch sub team associates) " Budget TBD Responsibilities The Regulatory Switch Head will have the following responsibilities: Develop and deliver innovative global regulatory switch strategies for specific Rx to OTC switch candidates Provide regulatory assessments of internal and external Rx to OTC switch opportunities. Represent global Regulatory Affairs on Rx to OTC switch project team Lead (or co-lead with Regional regulatory affairs representative) Health Authority meetings and negotiations in support of submission and approval of switch product registrations. Strategic leadership of consumer product development and registration projects to meet the business objectives for the region. Lead global Regulatory subteam supporting specific switch candidates through matrix management. Be primary point of contact between PCH WRS and BU WRS counterpart for internal switch candidates transitioning from other Pfizer BUs. Partner with Regional Regulatory Leads to direct the growth and professional development of regional and country RA team members. Full compliance with all government regulations and corporate policies including oversight of corrective actions for which the switch regulatory team is accountable. Coordination and implementation of consistent standards and processes, as well as sharing of best practices across the PCH regulatory organization. Qualifications Scientific Degree (advanced technical or medical degree preferred). Minimum 6-8 years experience in Regulatory Affairs. Regulatory Experience with Consumer products required; additional experience in Rx Regulatory Affairs may be advantageous, especially Rx to OTC switch experience. Proven ability to manage complex regulatory issues. Demonstrable experience across drug development and commercialization lifecycle, with proven examples of contribution. Broad RD experience in medical or technical areas preferred. Proven ability to consistently deliver to time, cost and quality standards. Regional regulatory experience including knowledge of and application submission processes and product life cycle management activities for various consumer product categories. Demonstrable experience of effective delivery of objectives in a complex matrix environment. Technical Competencies: Understanding of regulatory agency philosophies and guidelines. Experience preparing and submitting NDA's, variations and renewals. Working with and influencing, opinion leaders, external organizations and PCO's facilitating approval of submissions. Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines relevant to Regional regulatory strategies and implementation plans. Communicates effectively using a variety of mediums appropriate to the setting Can negotiate skillfully in tough situations with both internal and external groups. Can be direct and forceful as well as diplomatic. Gains trust quickly of other parties to the negotiations Effectively identifies issues and challenges and works with partner groups to identify options and implement agreed solutions Understands how role is impacted by and contributes to external business environment and financial drivers Understands and develops mitigation strategies for issues and drivers impacting the industry Equal Employment Opportunity 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 employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Pfizer in the U.S. In certain circumstances it may be advantageous to Pfizer to support the application(s) for temporary visa classification and/or sponsor applications for permanent residence so that a foreign national colleague can accept or remain in a work assignment in the U. S. For certain classes of temporary visas, the resulting work authorization may be specific to Pfizer and the specific job and/or work site. Pfizer may at its business discretion decide to or refrain from obtaining, maintaining and/or extending the temporary visa status and/or sponsoring a colleague for permanent residency and /or employment eligibility, considering factors such as availability of qualified U.S. workers and the colleague's long-term prospects for securing lawful permanent residence, among other reasons. Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work for Pfizer in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Pfizer's support of a colleague's temporary visa application or sponsorship of a colleague for permanent residence be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the colleague and Pfizer. *This job post was placed on PharmaDiversity Job Board with permission of this employer. If viewing this post anywhere else, the "apply" click should lead you to PharmaDiversity Job Board for authentic job post view with direct employer application. For application attention if web source is requested please use "PharmaDiversity" or "PharmaDiversity Job Board". Pfizer prefers that you apply to this job directly on their site