Sign In
 [New User? Sign Up]
Mobile Version

Manager, Pharmaceutical Manufacturing Site Regulatory Affairs Strategy, McPherson, Kansas

Pfizer


Location:
Mcpherson, KS
Date:
08/18/2017
2017-08-182017-09-16
Job Code:
1053029
Pfizer
Apply on the Company Site
  •  
  • Save Ad
  • Email Friend
  • Print
  • Research Salary

Job Details

Job Title Manager, Pharmaceutical Manufacturing Site Regulatory Affairs Strategy, McPherson, Kansas

JobID 1053029

Location: Mcpherson, KS

Description 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.

Hospira, a Pfizer company, is the global leader of injectable drugs and is committed to putting patients first by improving access and care worldwide.

The Manager, Pharmaceutical Manufacturing Site Regulatory Strategy, McPherson, Kansas reports to the Senior Director, Site Regulatory, Process Optimization, Efficiency and Compliance for Pfizer Essential Health (PEH). The Manager assures that new products manufactured at the McPherson, Kansas manufacturing site are developed and maintained in line with the global registration requirements of targeted countries and obtains expedient registration of products in a cost effective manner and maintains registrations of existing products in compliance with applicable regulations. S/he will also serve as the site interface during regulatory site inspections.

S/he will collaborate with colleagues/teams across PEH Global Regulatory Affairs (GRA) across global, regional, and country, Pfizer Global Supply (PGS), Worldwide Safety &; Regulatory (WSR) - Medical and WRO, Pharmaceutical Sciences/R&;D, etc. All organizational relationships are global in nature.

• Develops global regulatory strategies for new product development projects and manufacturing improvements/changes to existing products, and analyzes risk vs. benefit in regulatory strategies to ensure successful review by regulatory authorities.

• Manages the preparation and maintenance of global registration packages and responses to deficiency letters. Negotiates submission data requirements and deliverable dates with regulatory authorities and internal technical teams. Author with team members, key pieces of regulatory submissions.

• Acts as a point person for regulatory agency interactions (either written or oral) including preparation of briefing packages and strategy for meetings, inspections, advisory committee meetings, and responses to agency letters pertaining to the assigned products/teams.

• Evaluates site manufacturing and labeling changes; and promotional materials for global regulatory impact and to ensure compliance with applicable regulations. Accurately describes these changes for ease of regulatory agency review.

• Maintains awareness of global regulatory legislation and assesses its impact on business and product development programs.

• Will directly manage up to 6 individual contributors and/or contingent workers, provide managerial support and training, establishing employee goals that align with other business partners, maintaining job descriptions, creating employee development plans, providing performance feedback and recruiting and retaining staff members.

• Occasional domestic (US) and international travel will be required.

• Typical schedule: Monday - Friday 8:00 AM - 4:30 PM.

• This position is located at our McPherson, Kansas pharmaceutical manufacturing facility; relocation provided.

• QUALIFICATIONS :

• Bachelor's Degree in pharmacy, biology, chemistry, pharmacology, engineering, or related subject is required; Master's Degree or PhD preferred

• A degree in a science related field will assist in problem solving technical issues as they relate to product development, manufacture and global registrations

• 5 - 8 years of experience in the pharmaceutical industry experience as needed for the position; sterile injectables preferred

• Minimum of 3 years of experience in one of the following: regulatory affairs, research and development (R&;D), quality assurance/compliance or a role at a pharmaceutical manufacturing facility

• 2 years of direct people management experience preferred

• Experience working directly with regulatory agencies. Sound knowledge of applicable portions of agency guidances and regulations

• Able to challenge scientific arguments

• Excellent oral and written communication skills

• Good interpersonal skills

• negotiating skills

• Good understanding of business needs

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Occasional domestic (US) and international travel will be required.

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.

Colleagues who are issued any type of progressive disciplinary action on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date disciplinary action is issued.

Legacy Hospira - Grade 18



**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.



This job is open only to Lawful Permanent Residents (as defined by 8 U.S.C. §1101(a)(20)), or Protected Individuals (as defined by 8 U.S.C. §1324b(a)(3), namely, U.S. Citizens, Refugees, and Asylees.



**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.



**Grade: 18**



+ Eligible for Relocation Package

+ 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.


Apply on the Company Site
Powered By

Featured Jobs[ View All ]

Featured Employers [ View All ]