Manager, Regulatory Affairs - Device and Combination Products
Lake Forest, IL  / Detroit, MI  / Milwaukee, WI  / Middleton, WI  / Pleasant Prairie, WI  / Monticello, IL  / Minneapolis, MN  / Washington, DC  / Kalamazoo, MI  / Portage, MI  / Silver Spring, MD  / Reston, VA  / St. Louis, MO  / Denver, CO  / Pittsburgh, PA  / Memphis, TN  / Las Vegas, NV  / Birmingham, AL  / Montpelier, VT  / Miami, FL  / Atlanta, GA  / Boston, MA  / Bentonville, AR  / Aliso Viejo, CA  / Anaheim, CA  / Sacramento, CA  / San Diego, CA  / San Francisco, CA  / South San Francisco, CA  / Groton, CT  / Naples, FL  / Albany, GA  / Itasca, IL  / Columbia, MD  / Andover, MA  / Cambridge, MA  / Needham, MA  / Rochester, MI  / Chesterfield, MO  / Weldon Spring, MO  / Reno, NV  / Madison, NJ  / Somerset, NJ  / New York, NY  / Pearl River, NY  / Rouses Point, NY  / Rye Brook, NY  / Cary, NC  / Durham, NC  / Sanford, NC  / Beachwood, OH  / Franklin, OH  / Carlisle, PA  / Collegeville, PA  / West Chester, PA  / Bristol, TN  / Westlake, TX  / Richmond, VA  / Fairmont, WV  / Nashville, TN  / Bridgewater, NJ  / Peapack, NJ  / Cumberland, RI  / Saint Louis, MO  / Caguas, PR...View All
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Posted 1 day ago
Job Description

Why Patients Need You

We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking, and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines.

What You Will Achieve

You will represent Pfizer as an approval liaison in the regulatory affairs team. You will play the critical role of providing strategic product direction to teams while interacting with regulatory agencies and negotiating with them to expedite approval of pending registrations. Due to your expertise, you will be the regulatory liaison on the project team throughout the product lifecycle and a regulatory representative to marketing or research project teams and government regulatory agencies. Your understanding of regulatory procedures will help in development of submission of product registration, progress reports, supplements, and amendments.

As a Manager, you provide guidance to operational teams for managing projects. Your planning skills will help in preparing forecasts for resource requirements, and providing areas of improvement for products, processes or services. Through your comprehensive knowledge of principles, concepts and theories of the discipline, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate agreements between different teams.

It is your dedication that will help in making Pfizer ready to achieve new milestones and help patients across the globe.

Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage,joy, equity and excellence. Ourbreakthrough culture lends itself to our dedication to transforming millions of lives.We value every employee and throughout their careerencourage them to grow, developand express their viewsfreely.

How You Will Achieve It

  • Provide guidance, lead/co-lead projects, manage own time to meet objectives, and plan resource requirements for projects across the division.

  • Liaise with and provide input/direction to Global Chemistry Manufacturing and Controls, and any other key stakeholder to ensure the filing strategies for initial registrations and the lifecycle submissions are defined and executed and the regulatory requirements are met, ensuring a submission ready dossier.

  • Work in collaboration across the organization with stakeholders to deliver efficiencies in regulatory submissions and processes.

Qualifications

Must-Have

  • Bachelor's Degree

  • 5+ years of demonstrated experience in regulatory affairs or in a regulated industry.

  • Medical Device Regulatory Affairs experience required.

  • Demonstrable experience of effective delivery in a complex matrix environment.

  • Regulatory experience including knowledge of New Drug Application (NDA)/Investigational New Drug (IND)/510(k)/PMA submission processes.

  • In depth knowledge of national/regional regulatory legislation and guidelines.

  • Knowledge of pharmaceutical analytics technology, pharmacology, toxicology and medicine.

  • Leadership qualities and management skills, team oriented with problem solving skills.

  • Strong written and verbal communication and interpersonal skills.

Nice-to-Have

  • Master's degree

  • Relevant pharmaceutical experience.

Other Job Details:

  • Last Date to Apply for Job: April 23, 2021

  • Additional Locations: USA - Remote

  • Eligible for Relocation Package: YES

  • Eligible for Employee Referral Bonus: YES

#LI-REMOTE

For roles based in Colorado:

The annual base salary for this position ranges from $90,500 to $150,900. In addition, this position offers an annual bonus with a target of 15% of the base salary and eligibility to participate in our share based long term incentive program. Benefits offered include a retirement savings plan, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.

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

#LI-PFE

 

Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
5+ years
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