Regulatory Response Director - Collegeville, PA | Biospace
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Regulatory Response Director

Pfizer Inc.

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Location:
Collegeville, PA
Posted Date:
3/26/2017
Position Type:
Full time
Job Code:
83536.85218
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

About Pfizer

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.



Role Description

Pfizer is committed to the delivery of safe and effective products to patients and consumers, a fundamental element of our Company's Purpose and Mission. To meet this commitment, Pfizer maintains a quality-focused culture to ensure the highest priority is placed on the safety, efficacy and reliability of our products, the safety of our patients and consumers, the quality of data supporting regulatory submissions, and interactions with our stakeholders The Regulatory Response Director is an SME responsible for owning the process of generation of regulatory responses on behalf of and with the sites who have been the subject of inspection observations. Key elements of the role involve leading the development of a strategy for site responses in partnership with key QO and network senior leader stakeholders within the required timelines for response. This role requires excellent, leadership, facilitation and communication skills and the ability to oversee complex issues with a sense of urgency. The role will also involve the establishment of novel programs to support sites in skillset development in the area of response writing.



Responsibilities

Regulatory Inspection Response Support
* Owns the process of generation of regulatory responses with the support of the site. Responsible for development of the strategy for the site response , establishment of an ownership model for data gathering, a project plan with timelines of key deliverables to be met. Assist the response owner, manufacturing sites, and corporate functions, as needed, to evaluate specific issues within the inspection findings and the key elements to be included in the response.
* Facilitate the draft and editing of regulatory responses based on input from the response owner, subject matter experts (SMEs), and stakeholders, which includes leading the process of verifying the specific issues in the inspection report are adequately addressed.
* Coordinate multi-function teams that are responsible for providing input into the regulatory responses, including driving accountability for obtaining required information and meeting defined due dates.
* Engage response owner, SMEs, and stakeholders (technical experts, senior leadership) to provide timely feedback on the proposed response, including facilitation of issue resolution and appropriate escalation of conflicts within the team and other stakeholders to ensure project success.
* Ensure responses are submitted by defined due date in conjunction with the response owner and senior leadership. Inspection Readiness Support
* Provide support, where required, to the Inspection Readiness team including participation in inspection readiness programs directly at sites when scheduled such as leading coaching and remediation programs.

Requirements

Qualifications

Education and Experience: * Strong decision-making skills, routinely demonstrated in highly complex environments
* Ability to interpret and apply regulations, regulatory guidance, codes and public expectations
* Possesses the leadership skills to engage and influence colleagues at all levels within the organization including senior stakeholders
* Must have a heightened sense of urgency and a demonstrated drive to deliver results
* Excellent English written communication skills with experience in writing technical reports
* Experience in Operations and/or Quality in a Pharmaceutical industry , with demonstrated problem-solving expertise in GMP operations
* Ability to recognize and understand potential quality ramifications of issues
* High level of information literacy, including an ability to recognize when information is needed and an ability to locate, evaluate, and use effectively the needed information in technical documents.
* Strong attention to detail.
* Ability to collaborate successfully with internal and external partners (e.g., response owners, subject matter experts, senior leadership, etc.) * Current and in-depth knowledge cGMP regulations and expectations sufficient to readily interpret, lead discussion, and provide guidance based on the applicability of the regulations to the subject being evaluated.
* Must understand a variety of quality/operational systems that support facility, product design, development, production, distribution, installation, support and service and understand the principles of quality management.
* Proven ability to consistently perform in a variety of settings and circumstances
* BS degree in Life Sciences or related field, Master's degree preferred with 10 years or more related experience.\ NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Travel estimated to be approx. 40% of the time but may vary. Travel on occasion may be at short notice.



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.