1+ months

Regional Regulatory Strategist (RRS), Senior Manager, US Rare Disease

Collegeville, PA 19426

This role is the exciting opportunity to join Pfizer's Global Regulatory Affairs department. The ideal candidate will have US and Emerging Market Regulatory experience, ideally encompassing the Rare Disease drug development lifecycle. This is an energetic and diverse Global Regulatory Affairs team and you would be working with colleagues locally and around the globe.

We have a clear purpose - Breakthroughs that change patients' lives . Our values and behaviours of 'Courage', 'Excellence', 'Equity', and 'Joy' create an organisational culture in which talent development plays a central part in attracting and growing the best Regulatory Affairs expertise.

**Role Responsibilities**

**Senior Manager**

The major duties and responsibilities will include but are not limited to:

+ Function as US Regulatory Lead for assigned asset/s, including a program in development. Be the single point of contact with US FDA for all US work/submissions for assigned program/s.

+ Be the single point of regulatory contact for internal stakeholders as the US Regulatory Lead for US initiatives associated with assigned program/s, including providing strategic input into development, lead IND submission, and routine maintenance work/filings and support of lifecycle initiatives as relevant.

+ Potential to take on additional responsibility for projects associated with gene therapy assets and/or Emerging Markets (EM) Regulatory work for assigned asset/s, including asset s in development. Represent above country EM Regulatory to local country regulatory colleagues to help enable timely Clinical Trial Applications (CTA) filings, query resolution, support local country regulatory colleagues as needed.

+ Contribute to Regional and Global Regulatory Strategies and implementation plans (including core labels, risk registers) developed for assigned project/s.

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

+ Partner with project teams and other stakeholders to ensure required regulatory contributions (IND, NDA/BLA, supplements, annual reports etc) meet business needs and are provided to the project teams and Health Authorities, to agreed time, cost and quality standards.

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

+ Ensure 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.

+ Work closely with other Regulatory Strategists within and across sites to ensure consistent and appropriate processes, systems, working practices, shared learnings and quality standards.

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

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

+ Develop and maintains constructive working relationship with key internal stakeholders and Health Authority contacts as appropriate.

+ Extensive experience in leading and directing contributions and communication of complex Regulatory Strategies both at the team level and to management/ governance.

+ Leading the partnership with project teams and stakeholders within the global and in-country organisations.

+ Champion of working regulatory practices and track record for process improvement and sharing learnings widely

**Organizational Relationships**

+ Reports to Global Regulatory Portfolio Lead (GRPL)

+ Works with internal Global Regulatory Affairs groups and relevant project teams. In addition, works with relevant development/commercial team representatives.

+ Partners with Regional, Medical, Regulatory and Commercial colleagues including, Country Regulatory Managers.

+ Works with external contacts in Regulatory Agencies, as well as relevant experts and key opinion leaders.

+ As needed works with other International Regulatory contacts.

+ Ensures alignment with Global Regulatory Lead and GRPL

+ Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

**Senior Manager Qualifications, Skills and Experience**

+ Demonstrable experience across the drug, discovery, development and commercialization lifecycle, with proven examples of contribution.

+ Proven ability to consistently deliver to time, cost and quality standards.

+ Strong strategic thinking, project management, team working, problem solving, communication and interpersonal skills.

+ Knowledge of national/regional legislation and guidelines.

+ Understanding of business and financial environment, drug development process and the pharmaceutical industry.

+ Knowledge and understanding of quality systems, processes, audit and inspections.

+ Ability to influence different levels in the organization and build networks internal and externally.


+ Graduate degree in the sciences is required

+ 7-11+ years of regulatory experience is required

+ Extensive experience in US regulatory affairs

+ Proven ability to manage complex and time-critical regulatory issues

+ Proven ability to assess/predict the impact of potential team decisions on regulatory strategy, timelines, and probability of regulatory success.

+ Exceptional strategic thinking, project management, team working, problem solving, communication, influencing and interpersonal skills.


+ PhD in the sciences is preferred

+ Rare Disease, drug development experience an advantage.

+ External regulatory network and involvement in external initiatives an advantage

**Additional Information**

+ **Eligible for Employee Referral Bonus:** Yes

+ **Additional locations:** Groton, CT or New York, NY or Lake Forest, IL or Cambridge, MA


**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.

**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.

Regulatory Affairs


Posted: 2020-04-16 Expires: 2020-05-27

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Regional Regulatory Strategist (RRS), Senior Manager, US Rare Disease

Collegeville, PA 19426

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