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Senior Manager, Regulatory Strategy (Anti

Pfizer


Location:
New York, NY
Date:
09/19/2017
2017-09-192017-10-18
Job Code:
1614442
Pfizer
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Job Details

Job Title Senior Manager, Regulatory Strategy (Anti

JobID 1614442

Location: New York, NY

Description **ROLE SUMMARY**

Manages the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports. Provides strategic product direction to teams on interaction and negotiates evidence with regulatory agencies. Interacts and negotiates with regulatory agency personnel in order to expedite approval of pending registration and answers any questions. Serves as a regulatory liaison on the project team throughout the product lifecycle. Participates in one or all of the following activities: development of product plan, regulatory strategy, risk management, implementation plan, and chemistry manufacturing control (CMC). Ensures that pre-clinical and clinical trials designs meet regulatory requirements. Ensures rapid and timely approval on of new drugs, biologics/biotechnology and/or medical devices and continued approved status of marketed drugs or medical devices. Serves as regulatory representative to marketing or research project teams and government regulatory agencies. Provides advice to development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations. Coordinates, reviews, and may prepare reports for submission. May coordinate and maintain reporting schedules for new drugs, medical devices, and biologic/biotechnology and marketed products notices.



**Role Description**

Supporting the Pfizer Essential Health (PEH) Business Unit, the Global Regulatory Affairs Strategist reports to the Director, Cluster Lead of the Anti-Infectives Therapeutic Area and will provide ROW (Rest of the World) interactions dealing with complex regulatory issues, such as, NCE filings, new indications, safety labeling changes, management of post approval commitments/requirements, new dosage regimens, dosage forms, media reports of safety concerns). Works with internal PEH groups and relevant project teams. In addition works with relevant development/commercial team representatives within the PGS, and R&D (Worldwide Safety Operations and Risk Management, Worldwide Safety Sciences, Medical, Pharmaceutical Sciences, Global Manufacturing Compliance and Legal).



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 the ROW Health Authorities 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 in the Anti-Infectives Therapeutic Area.

+ Develop and implement regulatory strategies in support of new submissions, including NCEs and to maintain registrations. Maintain product licenses across all product platforms in ROW markets including Asia pacific, Latin America, Eastern Europe, China and Africa Middle East).

+ Ensure that product maintenance activities (product renewals, AQRT's, regulatory queries, etc.) are managed and responded to in line with product role, consistent with departmental procedures an including liaison with other functional groups to ensure that response targets are met.

+ Co-ordinate with regional and country strategists the receipt, distribution and response to regulatory queries, in line with product role, consistent with departmental procedures and including liaison with Rapid Response Team (RRT) members to ensure that response targets are met.

+ Create and Deliver the regulatory strategy that aligns with business needs

+ Manage regulatory aspects of projects/products, including the preparation and submission of correspondence and applications to regulatory agencies.

**ROLE RESPONSIBILITIES**

As an individual contributor, the major duties and responsibilities will include, but are not limited to:



+ Accountable for ensuring or contributing to Global Regulatory Strategies and implementation plans (including core labels, risk registers) developed for assigned project/s.

+ Ensures regulatory contributions achieve the objectives in the strategy, achieve agreed standards, and minimize resource demands while maximizing overall project delivery time and probability of success and facilitating post filing activities.

+ Partners with project teams and other customer groups (e.g., Brand Teams) to ensure required regulatory contributions (line plans, IND, NDA) meet business needs and are provided to the project teams, to agreed time, cost and quality standards.

+ Ensures regulatory plans are monitored, progress/variance communicated to Senior Management and any risks (from emerging technical data, changing internal objectives or external threats) mitigated

+ Ensures an aligned regulatory position is reached and communicated for all key issues for assigned project/s, and that these regulatory positions supporting the business are championed and communicated.

+ Works closely with other Regulatory Product managers within, and across, sites to ensure consistent and appropriate processes, systems, working practices, shared learning's and quality standards.

+ Implements systems, processes and procedures relating to regulatory strategy productivity improvements, ensuring that these facilitate the sharing of information across the relevant lines.

+ Engages in appropriate activities in order to influence the regulatory environment through Agency contacts and Trade Associations as appropriate.

+ Ensures business compliance and implementation of and adherence to Regulatory standards.

+ Develops and maintains constructive working relationship with Health Authority contacts

+ Deliver project/product regulatory strategy, risk assessment, and PRS for assigned projects/products.

+ Lead and/or participates in Regulatory Teams for assigned projects/products.

+ Deliver project/product regulatory strategy, risk assessment, and PRS for assigned projects/products.

+ Develop detailed understanding of ROW regulatory guidelines and technical requirements and a broad understanding of the global regulatory environment.

+ Contribute to the preparation of global regulatory strategies and plans for the targeted ROW countries, including review of existing regulatory guidelines, competitor products and relevant literature.

+ Delivering the project/product regulatory goals and aligning the regulatory strategy with global/regional business needs.

+ 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.



**QUALIFICATIONS**

Bachelor's Degree is required; scientific discipline is ideal; advanced scientific degree (PhD; PharmD, Master's) and/or DMS or MBA may be an advantage but is not essential. 10 years of experience required with BS/BA and 5 years of experience required with advanced degree.

- Relevant regulatory experience working with ROW Health Authorities is required.

- Demonstrated Health Authority interactions with complex regulatory issues is required (examples:, NCE filings, post marketing commitments/ requirements and/or safety studies, 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 functional, 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.



+ Expected travel 10%.

+ This role can either be located at NY HQ or Peapack, NJ



**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.



**Sunshine Act**

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.



Last day to apply: September 28, 2017

Pfizer Grade 15, exempt

Eligible for Employee Referral Bonus

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.


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