Director, Regulatory Labeling Jobs

New

Regulatory Affairs Senior Director - Global Regulatory Leader - Obesity

In this vital role you will support products in the Obesity Therapeutic Area. Gl...

Location

United States

Salary:

220356.00 - 269853.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 5 years of regulatory experience in biotech or science
Master’s degree and 8 years of regulatory experience in biotech or science
Bachelor’s degree and 10 years of regulatory experience in biotech or science

Job Responsibility

To lead GRTs within Amgen’s GRAAS organization
To independently develop a comprehensive regulatory strategy for one or more high complexity programs, typically in late-stage development and/or with multiple indications, that takes into account worldwide regulatory requirements to drive product development, global registration, achievement and maintenance of desired regional labeling, and effective regulatory agency interactions
To provide Regulatory leadership to cross-functional teams for high complexity programs with major Regulatory deliverables such as global original marketing applications
Develop and implement global regulatory product strategies designed to achieve approval and target product labeling for prioritized assets in late development with highly complex development programs
Represent GRA on the product team and other key commercialization governance bodies, guide and influence the organization to achieve Regulatory objectives
Independently develop the Global Regulatory Strategic Plan and provide regulatory input into the product’s Global Strategic Plan. Obtain input from the GRT members to develop a global regulatory strategy which supports product development, registration and lifecycle maintenance. Identify and communicate regulatory risks
Provide regulatory direction in the development of the core data sheet to align commercial objectives in the context of available and expected scientific data, regulatory guidance, and precedent
Independently lead the planning and implementation of global regulatory filings (eg, clinical trial applications, marketing applications, label extensions)
Ensure consistency of evidence-based global product communication (eg, regulatory submission documents)
Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Fulltime

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 Regulatory Affairs

ILIA is looking for a Director of Regulatory Affairs to join the team in buildin...

Location

United States , Laguna Beach; New York City

Salary:

160000.00 - 175000.00 USD / Year

ILIA Beauty

Expiration Date

Until further notice

Requirements

Minimum Bachelor’s degree in a relevant field (e.g., Life Sciences, Chemistry, Cosmetic Science, Regulatory Affairs)
10+ years of regulatory experience in the cosmetic or personal care industry, with at least 3 years in a managerial or leadership role
In-depth knowledge of U.S. and international cosmetic regulations (e.g., FDA, EU, Health Canada), safety assessment practices, and industry standards
Strong analytical and problem-solving skills, excellent written and verbal communication skills, and the ability to work collaboratively across departments, vendors and government agencies
Proven ability to lead and mentor a team of regulatory professionals, fostering a high-performance culture focused on compliance and innovation
Strong network within regulatory agencies and industry associations
Ability to work in a fast moving, fast changing environment
This position may require occasional travel to meet with regulatory agencies, attend industry conferences, or other related travel

Job Responsibility

Develop and implement a global regulatory strategy that aligns with business objectives while ensuring product compliance and safety (e.g. market expansion, short and long-term regulation updates, etc.)
Responsible for ensuring that all products comply with relevant regulations and standards (e.g., FDA, EU Cosmetic Regulation, etc.) throughout their lifecycle, from product development to marketing and distribution
Collaborate and communicate effectively with internal and external teams including but not limited to
product development, research and innovation, all marketing functions, and quality assurance, to ensure compliance with domestic and international regulations
Oversee the preparation and submission of regulatory documents, including ingredient notifications, safety assessments, and product registrations
Oversee post-market surveillance, adverse event reporting, and recall management
Collaborate with product development, marketing, quality assurance, and supply chain teams to provide regulatory advice and guidance during product formulation, testing, and labeling
Coordinate with product marketing, product development and testing facilities to create claims substantiation protocols and consumer perception questionnaires
Review product labels, marketing materials, and communications to ensure compliance with advertising regulations and truthful representation of product benefits
Contribute to the utilization & advancement of our product lifecycle management (PLM) tool or internal tools to manage global registrations, claims substantiation, and documentation workflows

What we offer

Bonus Opportunity
Health Benefits - 100% employer-paid medical, dental & vision coverage
Flex Time Off - No cap on personal time off and paid company holidays
Seasonal Flex Days - Flexible scheduling to enjoy extra time under the sun during the Spring & Summer season
Parental Leave - Up to 18 weeks paid parental leave
401(k) - Save for your future with a 401(k) with a company match
Flexibility & Wellness Stipends - Monthly stipends to support remote work & self-care
Hybrid Work Model - Find your flow, working from home or from one of our offices
ILIA Products - Quarterly stipend to replenish your favorite products and try new ones

Fulltime

Director Development & Engineering

BONESUPPORT ™ AB is a leading Scandinavian biotechnology company based in Lund, ...

Location

Sweden , Lund

Salary:

Not provided

Cerament (Bonesupport)

Expiration Date

Until further notice

Requirements

M.Sc. degree within engineering or chemistry
Minimum 8 years relevant experience in medical device and/or pharma
Proven leadership and management experience
Experience with medical devices class II and class III preferred
Experience with medical device combination products preferred
Experience with taking medical devices through the development pipeline according to design control requirements for CE marking and/or FDA approval
Experience in Design transfer / implementation of a new products in Manufacturing
Experience from working with lifecycle management of product portfolio
Experience from and understanding of design control, risk management, CAPA investigation, labelling, requirements, and qualification/validation documentation at a level adequate for regulatory submissions Notified Body / FDA

Job Responsibility

Overall responsibility for Design Controls, Risk Management, Usability Engineering and Change Controls
Lead and motivate the Development team to achieve its objectives and being a high performing team
Structure, plan and lead the work within Development & Engineering
Ensuring product lifecycle management of current product
Responsible for changes required for commercial products
Development of new products in line with company strategy
Collaborate tightly with other core functions

What we offer

Dynamic and stimulating workplace
Great teamwork, innovation, passion, and performance

Fulltime

Quality Assurance Manager

The Quality Assurance (QA) Manager provides site-specific quality oversight and ...

Location

United States , Fenton

Salary:

80000.00 - 90000.00 USD / Year

Strive Compounding Pharmacy

Expiration Date

Until further notice

Requirements

High School Diploma or GED
Minimum of five (5) years experience in a quality or manufacturing department within a pharmaceutical, medical device, or allied health science environment
Proven experience in aseptic operations and working in regulated environments
Strong knowledge of pharmaceutical quality assurance practices, including deviation management, CAPA, change control, and documentation review
Ability to analyze and interpret data, identify trends, and recommend preventive actions
Strong organizational, communication, and problem-solving skills
Proficiency with Microsoft Office Suite and quality management systems (QMS)

Job Responsibility

Supervise the site Quality Assurance team, including task assignment, workload prioritization, timecard management, performance reviews, coaching, and discipline as needed
Lead QA candidate interviews and oversee onboarding, training, and competency development
Conduct routine QA team meetings and cross-department quality huddles
Train QA personnel to ensure proficiency in documentation, review, and compliance expectations
Conduct regular reviews of compounding, production, and cleaning documentation (batch records, cleaning logs, inventory sheets) for accuracy and completeness
Verify and reconcile all labeling to ensure control and accountability
Review temperature monitoring and Building Management System (BMS) alarms to verify timely investigation and resolution
Confirm that product test results meet specifications prior to release
Review documentation for media fill and process validation activities
Approve equipment calibration, preventive maintenance, and certification records to ensure adherence to schedules and standards

What we offer

Employer paid healthcare coverage available after 30 days of employment
Choice of an FSA/HSA
Voucher for new hire scrubs (if applicable)
Parental leave
401(k) plan with matching contributions
Weekends and holidays off
FREE COMPOUNDED MEDS to employees and immediate family members

Fulltime

New

Marketing Communications Manager

The Marketing Communications Manager will be responsible for supporting the exec...

Location

United States , Arlington Heights

Salary:

Not provided

Beatrice Daily Sun

Expiration Date

Until further notice

Requirements

Minimum of seven (7) years of professional experience in marketing communications, with a strong track record of success
Demonstrated expertise in graphic design, with proficiency in design tools (e.g., Adobe Creative Suite or equivalent)
Demonstrated experience and expertise in managing intranet and website content using CMS platforms
Strong social media management skills with proven results in engagement and growth
Advanced proficiency in PowerPoint and the Microsoft Office Suite
Exceptional verbal, written, and presentation skills
Ability to balance strategic thinking with hands-on execution
Self-starter with a dedication to excellence, resourcefulness, and the ability to thrive in a dynamic environment where responsibilities may evolve

Job Responsibility

Support the execution of a communications strategy to support business development goals
Design and produce marketing collateral (digital and print), presentations and branded materials that align with company messaging and visual identity
Maintain brand standards across all communication initiatives
Manage and update content for the company’s intranet, website and social media channels
Partner with business development leaders to create compelling proposals, pitch decks and client-facing presentations
Collaborate across teams to ensure consistent brand messaging and communication
Contribute to building and maintaining the company’s culture of excellence in a start-up environment where flexibility and adaptability are essential

What we offer

hybrid work model
competitive compensation package that includes a base salary, performance-based bonuses, comprehensive health benefits
meaningful opportunities for career advancement

Fulltime

New

Customer service field agent - driving

We are seeking an outgoing individual with strong communication skills for a dyn...

Location

United Kingdom , Castle Douglas

Salary:

12.55 GBP / Hour

Randstad

Expiration Date

January 10, 2026

Requirements

Valid UK Driving License
Owned Car
Willing to complete a DBS
Willing to obtain business car insurance
Willing to travel up to 40 miles
Excellent verbal communication skills and evidence of persuading reluctant respondents to take part in surveys
Self-disciplined, self-motivated, and happy to work with minimum supervision
Be proficient in the use of laptop and smartphone
Can demonstrate ability to be organised with well-developed planning skills
Proficient in using laptop and smartphone to receive, view and input information

Job Responsibility

Traveling to different locations to conduct surveys
Encouraging participation from a variety of people
Being the face of the Office for National Statistics (ONS)

What we offer

0.45p per milage
1 meal per 5 hours, (£7.50), 2 meals per 10 hours (£15)

Parttime

New

Senior Legal Counsel - Banking

A leading and well-established financial institution with a strong presence in t...

Location

Hong Kong , Hong Kong

Salary:

Not provided

Randstad

Expiration Date

January 10, 2026

Requirements

Minimum of 8 years of post-qualification experience gained either in a reputable law firm or a comparable financial institution
Admitted as a solicitor in Hong Kong, with strong knowledge of HK and PRC banking operations, products, and services
Fluent written and spoken English, Cantonese, and Mandarin, along with excellent communication skills to relate effectively at all levels of the bank

Job Responsibility

Provide contextual legal advice on a broad range of matters to business divisions and functions
Maintain legal oversight by attending product approval meetings and participating in strategic business decisions
Drive deal negotiations, manage dispute settlements, and assist the Head of Legal with various projects, including supervising and coaching junior legal staff

Fulltime

Director, Regulatory Labeling

Beam Therapeutics

Location:
United States , Cambridge

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
December 24, 2025

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