Manager, Regional Regulatory Strategist
Manager, Regional Regulatory Strategist
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$ 90900 - 151500
1 Vacancy
Job Description
JOB SUMMARY
This position is responsible for developing and implementing US regulatory strategy that aligns with business needs. Through membership of the relevant regulatory and cross functional development teams for assigned projects/products contribute to/lead the relevant regulatory strategy and operational activities for projects/products including preparation and submission of correspondence and applications to regulatory agencies and direct and/or indirect liaison with Health Authorities to facilitate the prompt review and approval of applications
JOB RESPONSIBILITIES
- Proactively contribute to/lead development of Global/Regional regulatory strategies and implementation plans developed for assigned projects/products and activities relating to registration procedures maintaining registrations product defense regulatory compliance commitment closures and clinical trials.
- Ensure regulatory contributions achieve the strategic objectives meet agreed standards and project delivery timelines whilst optimizing probability of success and facilitating development pre and post-filing activities.
- Accountable for managing submissions to ensure completeness and timeliness of submission package.
- Participate in project teams for assigned projects/products and actively coordinate and follow up with partner lines to ensure fit-for-purpose submission packages. Track analyze and solve submission challenges for assigned projects/products and develop clear project plans and timelines for priority products projects or portfolios as needed.
- In partnership with Strategy Lead ensure business compliance and implementation of and adherence to regulatory standards.
- Partner with project teams and other customer groups (e.g. Country or Regional Regulatory Managers Cross functional product teams Global Supply etc.) to ensure required regulatory contributions (Regulatory query responses briefing documents Global Regulatory Strategy Documents annual reports IND NDA MAA clinical trials etc.) meet business needs and are provided in accordance with agreed time cost and quality standards.
- Accountable for executing regulatory information searches for inspection readiness rapid response teams etc. database searches to contribute to strategic and historical analyses and decisions
- Work closely with other Regulatory Strategists and the GRS Chemistry Manufacturing and Control (CMC) Team Pfizer Global Supply within and across clusters/TAs and sites to ensure consistent and appropriate processes systems working practices shared learnings and quality standards
- Implement systems processes and procedures relating to regulatory strategy productivity improvements ensuring the sharing of information and learnings across the relevant lines.
- Play a supporting /active role in any appropriate activities in order to influence the regulatory environment through Agency contacts and Trade Associations as appropriate.
- Develop and maintain constructive working relationship with Health Authority contacts.
QUALIFICATIONS / SKILLS
- Bachelors degree with 4 or more years of experience
- PharmD / PhD / MSc preferred
- Knowledge of the regulatory environment and how this impacts regulatory strategy development and implementation and awareness of the functioning of the pharmaceutical industry
- Proven ability to manage complex issues with appropriate support and consistently deliver to time and quality standards such as global and/or regional regulatory and registration activities involved in the drug development process and/or post-marketing lifecycle management or leveraging regulatory policy issues to support commercial objectives
- Proven ability to partner successfully with stakeholders / partners (such as Regulatory Clinical Safety Drug Safety Research and Development (DSRD) Pharmaceutical Sciences Medical Commercial) and other partner lines to achieve objectives.
- Awareness of and ideally experience in successfully communicating with Health Authorities is preferred
- Strong problem-solving skills
- Strong written and verbal communication skills. Proactive ability to work well with appropriate level of independence and appropriate level of supervisor
ORGANIZATIONAL RELATIONSHIPS
Clinical and preclinical development staff other regional and global regulatory staff Regional and global Commercial and Safety Strategy.
Other Job Details:
- Last Date to Apply for Job: 24 JUNE 2025
Work Location Assignment:On Premise
Relocation assistance may be available based on business needs and/or eligibility.
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 providers 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. This position requires permanent work authorization in the United States.
Required Experience:
Manager
Employment Type
Full-Time
