Pfizer Senior Manager Global Regulatory Affairs Lead/US Strategist in New York, New York
Supporting the Pfizer Essential Health (PEH) Business Unit, the Global Regulatory Affairs Strategist reports to the Director, Cluster Lead Mens/Womens Health, GI, and Urology therapeutic area and will provide US FDA interactions dealing with complex regulatory issues dosage forms, new dosage regimes, safety labeling changes, media reports of safety concerns).
In a highly matrixed, fast-paced environment, s/he will:
Create and deliver strategic regulatory guidance for assigned projects/products, Strategies should be in alignment with global/regional positions, commercial goals, and key stakeholders/partner lines.
Develop and implement Regulatory Strategies for assigned projects/products including assurance that project prioritization, submission strategies, labeling, approvals, post-marketing lifecycle management activities, etc., are in place and delivered in accordance with time, cost and quality expectations for all assigned projects.
Manage regulatory aspects of projects/products, including the preparation and submission of correspondence and applications to regulatory agencies.
Direct and/or indirect liaison with Health Authorities (in conjunction with Country Regulatory
Leads (CRLs)) to facilitate the prompt review and approval of applications, supplements/variations, and commitment closures.
Lead and/or participate in global, regional and/or in-country Regulatory Teams for assigned projects/products.
Develop and implement regulatory strategies in support of new submissions and to maintain registrations. Maintain product licenses across all product platforms.
Understand regulatory environment and communicate priorities to global/regional stakeholders.
Deliver project/product regulatory strategy, risk assessment, and PRS for assigned projects/products.
Expected travel 10%.
As an individual contributor, the major duties and responsibilities will include, but are not limited to:
Developing or contributing to Global/Regional regulatory strategies and implementation plans developed for assigned projects/products., Ensuring regulatory contributions achieve the objectives in the strategy, meet agreed standards, and minimize resource demands while optimizing overall project delivery time and probability of success and facilitating post-filing activities.
Partnering with project teams and other customer groups (e.g., Country Regulatory Managers, Brand Teams, PGS, etc.) to ensure required regulatory contributions (briefing documents, Global
Regulatory Strategy Documents, annual reports, IND, NDA, MAA, etc.) meet business needs and are provided to the project teams, in accordance with agreed time, cost and quality standards.
Developing and maintaining constructive working relationships with Health Authority contacts.
Delivering the project/product regulatory goals and aligning the regulatory strategy with global/regional business needs.
Ensuring regulatory plans are monitored, progress/variance is communicated to Senior
Management and any risks (from emerging technical data, changing internal objectives or
external threats) are mitigated.
Developing fit-for-purpose submission packages in collaboration with partner lines
Ensuring an aligned regulatory position is reached and communicated for all key issues for assigned projects/products, and that these regulatory positions supporting the business are championed and communicated.
Working closely with other Regulatory Strategists and CMC Team within and across clusters/TAs and sites to ensure consistent and appropriate processes, systems, working practices, shared learnings and quality standards.
Implementing systems, processes and procedures relating to regulatory strategy productivity improvements, ensuring that these facilitate the sharing of information across the relevant lines.
Engaging in appropriate activities in order to influence the regulatory environment through
Health Authority contacts, Pfizer Country Office partners and trade associations as appropriate.
Ensuring business compliance and implementation of and adherence to regulatory standards.
Partners with other Regulatory Strategists and PEH RA Brands CMC team to assure consistent and appropriate regulatory support; partners with other relevant PEH R&D and WSR/WRD colleagues and relevant project team(s) members from other partner lines (i.e. Safety, Commercial, Medical/Clinical, DSRD, Pharmaceutical Sciences, Legal, etc.) to achieve objectives; works directly or indirectly with external contacts in Health Authorities within assigned portfolio, as well as with relevant experts and key opinion leaders.
Bachelor's Degree is required; scientific discipline is ideal; advanced scientific degree (PhD, PharmD, Master's) and/orDMS or MBA may be an advantage but is not essential.
5 years regulatory strategy experience required.
Relevant US regulatory experience (FDA) is required.
Demonstrated US FDA interactions with complex regulatory issues is required (examples: post marketing requirements and/or safety studies, pediatric or adult clinical studies, new indications, new dosage forms, new dosing regimens, safety labeling changes, media reports of safety concerns).
Knowledge of the regulatory environment and how this impacts regulatory strategy development and implementation.
Proven experience in managing global and/or regional regulatory and registration activities involved in the drug development process and/or post-marketing lifecycle management including ability to manage complex regulatory issues.
Experience managing multiple products simultaneously and different stages of the product lifecycle is highly desirable.
Proven ability to deliver to time, cost, and quality standards.
Successful partner with Regulatory, Commercial, Safety, Medical and other partner lines to achieve objectives in a cross function, matrixed organization.
Proven track record of success in negotiating with major Health Authority(ies), including leading such interactions .
Demonstrated strategic thinking and ability to integrate strategies into actionable plans.
Proven ability to deliver in a highly matrixed organization.
Strong written and verbal communication skills. Desirable experience would include a strong track record of demonstrating extensive depth and breadth of regulatory strategy, enabling a leadership role to be assumed which requires minimal supervision.
Agile, flexible in changing environment.
Willing to mentor other team members.
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.
Eligible for Employee Referral Bonus
Pfizer Grade 14, Exempt
The successful candidate can fill the role from any US Pfizer location.
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.