Director, BE Regulatory Relations Job at Barclays (Paris)

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

Audit Director – U.S. Regulatory Reporting Transaction Testing

The Audit Director is a senior level management position responsible for contrib...

Location

India , Mumbai

Salary:

Not provided

Citi

Expiration Date

Until further notice

Requirements

BA/BS or equivalent
Related certifications (CPA, ACA, CFA, CIA, CISA or similar) are a plus
Statistical, Computer Science or Computer Engineering qualifications will be an advantage
15+ years of experience in a related role
Understanding of industry best practices and regulatory expectations for Data management (e.g. BCBS 239)
Knowledge of data quality software including Big Data (e.g. Paxata, Hadoop) will be an advantage
Detailed knowledge of substantive testing methodologies designed to assess the material accuracy of key reports, including data tracing and transaction vouching
Demonstrated experience in managing teams and managing integrated internal audit and assurance delivery within a matrix reporting environment

Job Responsibility

Development and completion (and ongoing update) of an effective audit strategy and plan (including budgets) that provides thorough, risk based substantive coverage of the data utilized in certain U.S. Regulatory Reports
Working closely with Product and Function Chief Auditors to ensure delivery of a plan of work that provides assurance for the accuracy of these reports
Interacting with U.S. regulators to provide updates and briefings on audit perspectives of the quality of the data utilized in report production
Contributes to strategic direction of Citi’s Internal Audit (IA) function in the establishment of reporting methodologies, organizational design and effective positioning of the function to ensure provision of independent assurance
Uses excellent communication, leadership and strong management skills to influence a wide range of internal audiences including respective product or, function, executive management partners and external audiences including regulators and external auditors
Responsible for the delivery of a high quality, value-added regulatory-required audits on time and to specification
Ensures the delivery of an audit reports that is complete, insightful, timely, error free and concise
Ensures timely delivery of high-quality comprehensive regulatory and internal audit issue validation, and, where determined appropriate, issue validation on other remediation actions, including issues arising from the external auditors, consultants and other parties
Contributes towards the delivery of high impact reports of IA's contributions to executive management, regulators, and Citigroup and Citibank boards' sub-committees, developing trend analyses and thematic reporting
Manages multiple teams of professionals

Fulltime

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

Associate Director Biostatistics

Amgen is expanding its global Biostatistics capabilities, with Amgen India (AIN)...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate in Statistics/Biostatistics (or related subject with high statistical content) with at least 12+ years of post-graduate statistical experience in the pharmaceutical industry or medical research
Master’s degree in Statistics/Biostatistics (or related subject with high statistical content) with at least 16+ years of post-graduate statistical experience in the pharmaceutical industry or medical research

Job Responsibility

Provide sound statistical guidance to clinical development, reimbursement, and medical affairs
Oversee statistical contributions to protocols, randomization specifications, statistical analysis plans (SAPs), clinical study reports (CSRs), and key trial documents
Ensure alignment of study design and analysis with scientific rigor, regulatory requirements, and Amgen policies
Collaborate cross-functionally with global teams to deliver high-quality analyses, publications, and regulatory filings
Contribute to innovative trial designs, advanced methodologies, and process improvement initiatives
Execute biostatistical strategies across the product lifecycle, from early development through post-marketing
Provide consultancy and training to colleagues across R&D
Support governance of outsourced statistical activities, ensuring adherence to Amgen standards and regulatory compliance
Represent Biostatistics in cross-functional and external interactions (e.g., with regulatory agencies, investigators, or data monitoring committees)
Drive technology adoption leveraging AI capabilities to streamline statistician’s work

What we offer

Vast opportunities to learn and develop within our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Audit Director

The Audit Director is a senior level management position responsible for contrib...

Location

Canada , Mississauga

Salary:

Not provided

Citi

Expiration Date

Until further notice

Requirements

15+ years of experience in a related role
Compliance Risk Management experience in second or third line of defense is preferred
Demonstrated success in business, functional and people management
Consistently demonstrates clear and concise written and verbal communication
Demonstrated ability to remain unbiased in a diverse working environment
Effective negotiation skills

Job Responsibility

Leads a global team of auditors to provide timely and complete assurance over the US Regulatory Issue Validations
Responsible for planning of audit coverage and delivery of high quality, value-added Regulatory Issue Validations in accordance with audit methodology
Leads validations owned by ICRM and coordinates models subject matter expertise for all other audit teams
Proactively manages IA’s relationship with multiple internal and external stakeholders, including senior risk and business executives, and government regulators
Uses communication and leadership skills to influence a wide range of senior internal and external audiences
provides impactful, valuable and ongoing IA input through active interactions with stakeholders and formal participation at key committees and management initiatives
Possesses, through direct hands-on experience, a strong understanding of Audit and Compliance
maintains an understanding of key relevant regulations, current business practices and industry trends
Supports and endorses the Quality Assurance (QA) function of IA, and resolve issues found by QA, improving audit processes and coverage
Ensures the adoption of Citigroup and Citibank Audit Committee Charters and the IA Charter, and engages in internal/external negotiations

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

Associate Director, Pharmacovigilance Scientist

The Associate Director, Pharmacovigilance Scientist will provide leadership, gui...

Location

United States , Waltham

Salary:

160000.00 - 200000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

A minimum of 10+ years of experience in global pharmacovigilance in pharmaceutical, biotech, or CRO setting with a Bachelors degree or 5+ years of experience with an advanced degree
Experience in safety data analysis, signal management, and benefit-risk evaluation
Knowledge of safety databases (Argus, ArisG/LifeSphere Safety, Veeva or similar), ICSR workflows, and MedDRA coding
Experience with authoring or contributing to aggregate safety reports, signal assessment reports
Working knowledge of relevant local and global regulatory requirements and guidance documents
Experience in creating or managing SOPs or Work Instructions
Strong ability to proactively identify signals, trends, risks, and initiate/manage risk minimization activities
Strong ability to work independently and collaboratively with internal and external partners in a demanding environment
Ability to prioritize, multitask, and deliver quality results that meet tight timelines
Fluency in written and spoken English with strong ability to communicate complex issues clearly

Job Responsibility

Perform and coordinate complex benefit-risk assessment and safety surveillance activities
Serve as a critical contributor to the safety governance framework, prepare safety data for review, coordinate and attend Safety Management Team and Medical Safety Board meetings
Coordinate and support strategies for safety assessments in collaboration with the safety physician and medical development as applicable
Lead and contribute to the management of aggregate safety reports (e.g., DSURs, PBRERs, PADERs, periodic line listings) including scheduling, planning, and authoring assigned sections
Collaborate with cross-functional teams to regularly review emerging safety data for the purposes of trend analysis and/or signal detection as applicable
Contribute to the preparation of queries in the safety database, retrieve and present data for regular and ad-hoc safety reviews
Perform safety signal management activities
conduct signal detection, author signal validation/evaluation reports, track and communicate findings
Collaborate cross functionally to access and utilize data visualization and analysis tools for regular and ad-hoc safety reviews
Lead or assist with the preparation of Risk Management Plans (RMPs)

What we offer

Comprehensive health benefits and tax-advantaged savings accounts
Flexible time off, 13 paid holidays, and a companywide year-end shutdown
Monthly wellness stipend
Generous 401(k) match
Disability and life insurance

Fulltime

Director, BE Regulatory Relations

Barclays

Location:
France , Paris

Category:
Banking

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 04, 2026

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