Regulatory Relations Program Director Job at Citizens Bank (Johnston)

Associate Director, Regulatory

This role will serve as the Regulatory Lead for our pivotal program leading to B...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor's degree in life sciences or related field required (advanced degree preferred)
Minimum of 5 years of experience in regulatory affairs for biopharmaceuticals or cell therapy (preferred)
Strong understanding of the drug development process from pre-clinical to commercialization, (prior BLA experience required)
Experience in reviewing and writing regulatory submission documents for global regulatory filings such as IND, CTAs, and BLAs/MAAs and related health authority interactions
Knowledge of GXPs and key requirements for clinical, nonclinical and CMC documentation for regulatory submissions in ICH regions
Excellent communication, negotiation, and leadership skills
Strong team orientation and passion for continuous self-development

Job Responsibility

Regulatory Strategy Development: Manage all regulatory aspects of Cabaletta’s lead program through pivotal clinical studies and BLA/MAA approval, including the preparation of clinical trial applications, amendments, correspondence, applications for expedited programs, health authority meetings, marketing applications, and labeling and promotional reviews for regulatory agencies, including FDA, Health Canada, EMA, MHRA and other countries, as applicable
Collaborate with cross-functional teams including clinical and nonclinical development, manufacturing, quality assurance, and medical affairs to develop and implement competitive regulatory strategies that expedite development and maximize the probability of success for cell therapy product development
Stay informed about evolving regulations and guidelines related to cell therapy and adapt strategies accordingly
Assess and communicate potential regulatory risks and propose mitigation plans
Regulatory Submissions and Compliance: Prepare and oversee the submission of regulatory documents, including INDs, CTAs, BLAs/MAAs, and other relevant submissions to regulatory agencies (e.g., FDA, EMA)
Ensure the quality and accuracy of regulatory submissions, adhering to timelines and requirements
Ensure compliance of programs and submission documentation with current regulations and guidelines governing cell therapy products
Regulatory Interactions: Represent the company during interactions with regulatory agencies, including meetings, teleconferences, and written communication
Prepare meeting requests, briefing documents, and coordinate and prepare teams for meetings with health authorities
Coordinate and prepare responses to requests for information from regulatory agencies

What we offer

health and retirement, PTO, and stock option plans

Director of Government Relations and Public Involvement

This position serves as Director of Government Relations and Public Involvement ...

Location

United States , Honolulu

Salary:

112030.00 - 179220.00 USD / Year

Honolulu

Expiration Date

Until further notice

Requirements

Training and Experience: A combination of education and experience substantially equivalent to graduation from an accredited college or university with major work in business or public administration or a related field and five years of responsible administrative, professional or analytical experience which involved active participation in the planning, development and execution of policies, programs and/or activities and which demonstrated the ability to analyze and formulate solutions for various operational or administrative problems, two of which shall have been in a governmental agency.
Knowledge of: principles and practices of administration, organization, personnel administration, budget formulation and control, public relations
functions, policies, standards, laws and rules and regulations applicable to the department
research methods and techniques
report writing.
Ability to: make administrative decisions applying facts, laws, policies, rules and regulations and precedents
prepare clear and concise policies, procedures, reports and correspondence
maintain cooperative and effective working and public relationship
plan, organize, direct the administrative functions of a department.
Persons seeking appointment must meet the health and physical condition standards deemed necessary and proper for performance of the duties.

Job Responsibility

Develops and recommends strategies for state, federal, and local legislative and regulatory initiatives
communicates HART’s project needs to legislators and government officials.
Reviews and interprets legal, policy, and transit-related materials
advises on recommended actions.
Leads public information and outreach strategies, overseeing communications, media relations, and community engagement for the Honolulu Rail Transit Project (HRTP).
Conducts research, prepares reports, and analyzes transit industry legislation and policy impacts.
Identifies and addresses issues affecting the HRTP, including proposed legislation and stakeholder concerns.
Represents the organization at meetings, hearings, and community events
serves as spokesperson to external groups.
Guides the analysis of public policy issues and monitors contractor communications and public outreach.

What we offer

Medical, prescription drug, vision, dental, and life insurance plans
Generous vacation and sick leave, earning up to 21 days per year
13 paid holidays annually (14 days during election year)
Retirement plan contributions through the Employees' Retirement System (ERS)
Deferred compensation options to invest pre-tax income for retirement
Flexible spending accounts for health and dependent care expenses
Pre-tax transportation benefits, including TheBus and vanpool options
Access to confidential counseling services through the Employee Assistance Program (EAP)
Additional perks include training opportunities and employer-funded Holo Card for eligible employees to use on public transit
Eligibility for Public Service Loan Forgiveness (PSLF) program, supporting employees dedicated to public service

Fulltime

Senior Director Public Health

The Senior Director, Public Health provides scientific and strategic leadership ...

Location

United States , Washington, DC

Salary:

150000.00 - 165000.00 USD / Year

American Cleaning Institute

Expiration Date

Until further notice

Requirements

Master’s degree required or Doctorate preferred, in public health, or a related field
Minimum 5 years of experience in scientific research management, regulatory science, or related public health programs
experience with FDA-regulated products strongly preferred
Demonstrated experience managing multi-stakeholder research programs or clinical studies under FDA frameworks
Comprehensive understanding of FDA rules and regulations, topical antiseptic safety and efficacy requirements, and relevant regulatory guidance
Excellent scientific writing and communication skills, including experience preparing manuscripts, white papers, and regulatory submissions
Exceptional oral and written communication skills
Ability to interact productively with both internal and external stakeholders, including non-scientific audiences
Proven ability to manage contractors, academic partners, and collaborations on scientific projects
Ability to work within a team environment as well as independently

Job Responsibility

Lead and oversee ACI’s Topical Antiseptics Program, including clinical and technical research supporting the FDA OTC Monographs and related scientific priorities
Keep abreast of emerging science and regulatory policies, monitor technical literature, and write and review technical reports, white papers, and publications for peer-reviewed scientific journals
Direct design, execution, and analysis of studies assessing product safety, efficacy, and antimicrobial benefits. Ensure compliance with regulatory and scientific standards
Serve as the primary scientific liaison to FDA and other regulatory bodies on antiseptic-related topics
interpret and communicate evolving regulatory expectations to ACI leadership and members
Coordinate and facilitate scientific work groups, technical committees, and member coalitions advancing antiseptic science
Prepare status/progress reports for presentation to ACI’s leadership and members
Develop and administer program budgets and deliverables
oversee contracts, research partnerships and consultant engagement
Develop and deliver scientific messaging for external stakeholders such as at scientific and technical conferences and meetings, and audiences for ACI technical communications

Assistant Director of NCLEX Review

Join our faculty at American Career College and discover an innovative learning ...

Location

United States , Ontario

Salary:

87964.06 - 127521.21 USD / Year

American Career College

Expiration Date

Until further notice

Requirements

A minimum of at least one (1) year's previous experience with program management
Knowledge in technological support and delivery of educational programs and services
Knowledge and evidence of strong management skills, and administrative systems management as applicable to specialized program area
Knowledge of state, federal and local laws/regulations relating to programs, governmental compliance, and other regulatory standards such as ABHES, BVNPT, BRN, and other accreditation standards
ATI product experience
A minimum of one to two years of professional testing and/or statistical data experience involving database management
Experience working with nursing programs
Experience with Blackboard Learning Management System
Experience with Campus Vue
Bachelor's degree from an accredited college or university that includes course work in education or business administration OR equivalent experience required

Job Responsibility

Providing each nursing program(s) with the necessary Assessment Technologies Institute (ATI) management and oversight to help each cohort achieve or exceed ACC's outcomes
Achieving a 90% or better first-time pass rate on the NCLEX each quarter
Collaborating with the Director of Nursing (DON), overseeing a comprehensive success plan that evaluates the effectiveness of ATI initiatives, creating new methods to improve specific ATI student/graduate and faculty performance
Developing/implementing administrative systems and procedures to monitor and improve ATI effectiveness and provides analysis and remediation strategies to help ensure students/graduates are actively engaged in their ATI program and that graduates pass NCLEX with a satisfactory level of performance on their first attempt
Serving as the campus ATI champion to support both existing students and graduates until NCLEX is passed

What we offer

HEALTHCARE
401(K) RETIREMENT PLANS AND EMPLOYER MATCHING
PROFESSIONAL DEVELOPMENT
DAY OF SERVICE
PTO DAY
COLLABORATION
MANAGEMENT AWARDS & RECOGNITION

Fulltime

Campus Director, Clinical Education - Physician Assistant

The Campus Director of Clinical Education, Physician Assistant is a key member o...

Location

United States , Ontario

Salary:

138230.12 - 200406.07 USD / Year

American Career College

Expiration Date

Until further notice

Requirements

For PA and Physician Candidates: Minimum of three (3) years of teaching, research, or clinical experience in a PA program/Medical School, or equivalent*** experience in health professions education, healthcare delivery, or related fields that directly support PA student learning and curricular outcomes.
For Non-Clinician Scientist candidates: Minimum of one (1) year of full-time experience in PA education, academic support, or curriculum development in alignment with program needs.
Demonstrated the ability to develop clinical and didactic curriculum, program evaluation and student assessment.
Leadership knowledge in the program field to cultivate a learner-centered environment and to foster excellence.
Knowledge and evidence of strong supervisory and management skills as applicable to specialized program area.
Knowledge of state, federal and local laws/regulations relating to programs, governmental compliance and other regulatory standards such as Title IV, WSCUC, and ARC-PA and other accreditation standards.
Physician Assistant/Associate (PA) Candidates: Graduation from an ARC-PA accredited PA program.
Master’s degree in education or a related health- or social-science discipline.
Current National Commission on Certification of Physician Assistants (NCCPA) certification or eligibility* to sit for the PANCE (initial certification) or PANRE (recertification) at the time of hire.
State PA licensure or eligibility* for licensure in state of campus location.

Job Responsibility

Collaborate as a member of the programmatic leadership team, which may consist of the MPA Dean/Program Director, Medical Director, Director of Academic Education, and Director of Student Success to achieve a shared vision for the program.
Collaborate with the MPA Dean/Program Director, Medical Director, and the WCU Clinical Operations team to develop, evaluate, and maintain clinical sites and preceptors sufficient in number and quality to meet ARC-PA Standards.
Communicate with MPA Dean/Program Director ongoing new site development and needed support to facilitate Program/Preceptor relationships, including support from the Medical Director.
Contacts, develops new and maintains established clinical affiliations, assuring all clinical sites meet the program’s prescribed learning outcomes, and securing appropriate contact and specific contractual agreement information including identified preceptors, number and types of placements, renewals, insurance and liability matters, and other pertinent issues important to seamless transition of students to clinical sites.
Prepares and submits to MPA Dean/Program Director annual program clinical calendar, individual student clinical placement schedule, and oversees preparation and formal distribution of student clinical placement assignments with detailed site, setting, and discipline-related information on timeline set by MPA Dean/Program Director.
Provide leadership, oversight, and performance evaluation for the clinical phase team, as assigned.
Develops, maintains, and conducts a schedule for clinical site visitation and presents a written copy to the MPA Dean/Program Director at a specified time each year with updated list of new and renewed affiliation agreements.
Develops, implements, stores, and updates as needed Clinical Site Visit Forms to ensure rapid retrieval and MPA Dean/Program Director and faculty access to documented site visits and/or phone calls.
Conduct clinical site visits and monitor student performance in Supervised Clinical Practice Experiences (SCPEs).
Lead the design, development, implementation, coordination and ongoing evaluation of an innovative clinical curriculum to ensure alignment with ARC-PA Standards, PAEA’s End-of-Rotation Exams, the NCCPA blueprint, and degree requirements.

What we offer

medical
dental
vision
flexible spending accounts
401(k) match
paid time off
holidays
parental leave
tuition reimbursement
adoption assistance

Fulltime

Director, Product Quality Leader

This individual will serve as a technical quality expert for one or more product...

Location

United States

Salary:

164000.00 - 225500.00 USD / Year

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

BA/BS in life sciences or related field required
Advanced degree desirable
12+ years of experience with Biotechnology, Pharmaceutical, Medical Device or other, highly regulated, industry
Preferred experience in biologics product development and licensure or technical support
Experience in both clinical and commercial phases of product lifecycle is highly desirable
Experience supporting combination products across clinical and commercial stages, including device quality considerations, is a plus
Excellent interpersonal and communications skills
Demonstrated strong leadership capability
Experience with influencing diverse stakeholders and driving accountability and decision-making in a highly matrixed, cross-functional environment
Highly capable of building strong, effective working teams

Job Responsibility

Serve as a technical quality expert for one or more products during clinical development through post-commercialization
Make technical quality-related decisions
Serve as the single point of contact on the CMC team for all quality functions, risks and issues
Provide efficient and effective quality leadership of CMC-related strategic activities
Drive associated quality decisions
Participate fully in CMC team meetings and other relevant technical forums
Partner with CMC Team and the Quality organization to identify, develop and prioritize long-term product strategies/initiatives
Accountable for creation of the product-specific Quality strategy
Lead the cross-functional Quality Partner Team (QPT) supporting Quality-related CMC deliverables
Own and manage the product quality risk register

What we offer

Discretionary annual bonus
Discretionary stock-based long-term incentives
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans

Fulltime

New

Director of Regulatory Affairs

Hemab seeks a Director, Regulatory Affairs who will be responsible for developin...

Location

Sweden , Greater Malmö Metropolitan Area

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a scientific subject area coupled with sufficient industry experience
8+ years of pharmaceutical industry experience
6 years of regulatory experience or a combination of 5+ years regulatory and/or related experience
Experience in rare diseases, especially rare hematological disorders, preferred
Understands and works effectively with team members and consultants to develop the regulatory framework for the clinical development of small molecules and biologic products leading to global marketing authorizations
Ability to advise on applicable regulations and guidance documents
Understands and interprets scientific data as it relates to regulatory requirements and strategy
Keeps abreast of new developments and therapeutic innovations, including regulatory requirements related to gene therapy and associated science
Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity, and adaptability
Demonstrates acceptable skills with increasing independence in the area of regulatory strategy

Job Responsibility

Develop and execute innovative global regulatory strategies for the global development of candidates for the treatment of rare, hematological disorders
Define, develop, and lead execution of strategies to maximize global regulatory success and achieve program objectives for complex development projects
Keep abreast of new developments in regulatory science and maintain oversight on the evolving regulatory landscape and advancing innovations
Understand and interpret scientific data as it relates to regulatory requirements and strategy
Represent Regulatory Affairs at project team meetings
Collaborate across technical functions to create innovative regulatory strategies and pragmatic solutions
Effectively communicate regulatory strategies and project developments to project teams, colleagues, line management, and key stakeholders
Proactively anticipate regulatory risks and develop mitigation strategies
Be accountable for all Regulatory Agency submissions and approvals, overseeing outsourced vendors and/or internal team members
Be the direct point of contact with health authorities, lead and manage Regulatory Agency meetings

Fulltime

Associate Director

Location

United States , New York

Salary:

150000.00 - 200000.00 USD / Year

Arrow Search Partners

Expiration Date

Until further notice

Requirements

Bachelor’s degree required
3-7 years of experience in a compliance role
J.D. required
Understanding of federal securities law and regulations strongly preferred
Experience with private fund marketing or distribution compliance a plus
Experience using compliance software/programs that support monitoring, reporting, and risk assessment activities
Ability to interpret legal and business terms and grasp concepts quickly

Job Responsibility

Coordinate across the firm on fund and managed account compliance and regulatory matters including SEC and CFTC registrations, ERISA, and federal, state and international securities laws
Review marketing materials, due diligence responses, investor communications and other fundraising and reporting related materials across various investment strategies
Coordinate and prepare U.S. and foreign regulatory reports and filings
Assist with forensic testing for annual compliance review
Assist with the compliance monitoring program including testing of investment guidelines and employee compliance requirements
Support selected firm-wide legal and compliance initiatives

Regulatory Relations Program Director

Citizens Bank

Location:
United States , Johnston

Category:
Banking

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 30, 2026

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Location:United States , Johnston

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