Pfizer Manager, (ANDA) Regulatory Affairs in Lake Forest H1, Illinois

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.

• Contribute to cross-functional teams and build regulatory expertise In line with defined product

responsibilities, utilize regulatory expertise to develop and deliver optimal regulatory

strategies/plans to support the achievement of business goals

• Provide regulatory strategy on the ANDA and 505(b)(2) NDA programs

•Possess regulatory CMC (chemistry manufacturing &; controls) expertise and ensure timely and quality regulatory submissions for ANDA and NDA programs.

•Be a liaison to FDA on pre-submission communications, such as controlled correspondences, pre-IND meeting or pre-ANDA meeting, etc., as required

• Coordinate and author amendments to the deficiency letters to obtain drug application

approvals

• Provide regulatory input to commercial strategic process

• Mentor the regulatory associate and review the submission dossier for completeness and

accuracy

• Keep cross-functional colleagues and key stakeholders informed of progress with regulatory

submissions

• Provide regulatory support to the marketing and quality assurance team with change controls to ensure compliance

• Keep abreast with current Agency guidance's/ recommendations and facilitate cross-functional awareness and understanding of regulatory issues and environment as appropriate

The Manager, Regulatory Affairs reports to the Associate Director, Regulatory Affairs and

supports Regulatory functions within Pfizer Essential Health.

The Manager, Regulatory Affairs ensures that the global regulatory strategy for the molecules

identified to meet global requirements. She/He will execute the

strategy for each molecule by representing regulatory affairs on the product core team, preparing the core dossier for assigned molecules, and working directly with the CRO assigned to product(s) for preparation and review of the core dossier. She/He will also liaise with local Health Authorities to negotiate data sets, filing pathways and submission timelines and rolling out the core dossier to in-region country staff for submission all while ensuring appropriate closeout of the submission through the review cycle, approval, and launch in preparation for ongoing life cycle management.

Qualifications

• Masters degree in science, chemistry, or pharmacy

• 6+ years regulatory experience in filing ANDA IND's, and 505b(2) NDA 's for sterile injectables, ophthalmic and solid dosage forms

• Experience of interacting with regulatory authorities

• Familiarity in managing pre-submission meetings with regulatory authorities

• Understanding of ex-US filing requirements is a plus

• Regulatory Affairs certification (RAC) is a plus

• Strong communication skills

EEO Statement

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.

II. 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.

Pfizer grade 11

Hospira grade 18

PHYSICAL/MENTAL REQUIREMENTS

Sitting, walking, etc. (physical requirements related to routine office work).

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.