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The Manager, Regulatory Affairs reports to the Associate Director, Regulatory Affairs and supports all Regulatory functions for the InnoPharma division within the company Essential Health and will have at least one direct report.
The Manager, Regulatory Affairs ensures that the global regulatory strategy for the molecules identified for the InnoPharma product line 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.
• 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 clinical, non-clinical programs and PSP plans for 505(b)(2) 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
• Lead the regulatory operation integration process to be in line with the company standard
• Possess regulatory CMC (chemistry manufacturing & controls) expertise and ensure timely and quality regulatory submissions
• 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
• Masters degree in science, chemistry, or pharmacy
• 6+ years regulatory experience in filing IND's, 505b(2) NDA and ANDA's for sterile injectables, ophthalmic and solid dosage forms
• Experiences on clinical regulatory
• 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
Sitting, walking, etc. (physical requirements related to routine office work).
Other Information - Internal
Colleagues who are issued an Incident Final Warning (IFW) 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 an IFW is issued.
EEO & Employment Eligibility
the company 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. the company 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. the company is an E-Verify employer.
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