- Report to the Global Regulatory Strategy Lead
- Participate in Regulatory and Cross Functional global teams for assigned projects/products.
- Contribute to regulatory strategy and operational activities for projects/products, including the preparation and submission of correspondence and applications to regulatory agencies.
- Assist in developing and implementing regulatory strategy that aligns with business needs, including projects and activities relating to clinical trials, registration procedures, maintaining registrations, product defense and regulatory compliance
- With supervision, direct and/or indirect liaison with Health Authorities (in conjunction with Country Regulatory Leads (CRLs)) to facilitate the prompt review and approval of applications including clinical trial applications, marketing authorization applications, supplements/variations, and commitment closures.
Under the direction of the Global Regulatory Strategy Lead:
- Provide regional input to the global regulatory strategy for estrasimod program.
- Assist in the implementation of tactics to facilitate the creation, review and approval of regulatory documents supporting clinical development activities leading to marketing application submission, review and approval.
- Prepare sections of initial BLA, NDA, INDs, and eCTD dossier filings and related lifecycle submissions, e.g., protocols and protocol amendments, informational amendments, annual reports, IND Safety Reports, DSURs/PADERs/PSURs and responses to FDA inquiries.
- Prepare FDA meeting requests and briefing documents. Coordinate and facilitate planning and execution of team engagements with health authorities, including meetings and all correspondence
- Perform critical review of technical reports and summary documents for submission to FDA (e.g., clinical protocols and study reports; investigator brochures, pharmacology & toxicology reports, CTAs, IMPDs, QOSs) for adherence to regulatory guidelines, strategies, and commitments
- Coordinate with contract research organizations (CROs) to ensure provision of documents supporting clinical trials and submission activities.
- Interpret applicable FDA and ICH guidelines and requirements related to the areas of nonclinical and clinical research, product development, and marketing applications
- Provide regulatory advice to project teams
- Identify registration needs and strategies and manage and coordinate the content development process (planning, creation, review and approval) of selected regulatory documentation (e.g., cover letters, forms, Module 1 documents) for inclusion in submissions to FDA
- BS degree in a science-related discipline with a minimum of 7+ years' experience in a regulatory function in the pharmaceutical/biotechnology industry, OR MBA/MS with 6+ years of experience.
- Experience in producing development (IND/CTA) and marketing applications (NDA/MAA) in eCTD format for global health authority submissions
Knowledge of product development activities, including non-clinical studies, clinical trials, and manufacturing
- NDA/MA preparation and/or commercialization experience preferred
- Strong leadership, organization, and prioritization skills
- Excellent analytical and project planning skill
- Proven ability to manage in a matrix environment and to work collaboratively across all levels of the organization
- A previous track record of success in effectively prioritizing assignments for multiple projects simultaneously
- Highly proficient in Word, Excel, PowerPoint, Microsoft Project, and SharePoint; experience with Smartsheet is helpful.
- Hands-on individual who appreciates growth opportunities offered in a dynamic, fast-growing pharmaceutical company
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.PHYSICAL/MENTAL REQUIREMENTS
NoneNON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Where appropriate and supported by business goals, some travel may apply (up to 10%) Last Day to Apply: May 25h, 2022 Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.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.