Associate Director, CMC Regulatory Affairs Job at AbCellera Biologics (Vancouver)

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

Associate Director Regulatory Affairs

The Associate Director is a senior people leader responsible for the operational...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree, 12 years of experience in CMC and/or Device regulatory, and 5 years of leadership experience
Master’s degree and 14 years of experience in CMC and/or Device regulatory, and 6 years of leadership experience
Bachelor’s degree, 15 years of experience in CMC and/or Device regulatory, and 7 years of leadership experience

Job Responsibility

Provide inclusive, inspiring leadership for staff within the CMC & Device Regulatory team in AIN
Attract, hire, develop, and retain top regulatory talent
foster a culture of learning, engagement, inclusion, and high performance
Ensure staff receive appropriate onboarding, development, and ongoing support
Promote behaviors and ways of working consistent with Amgen’s values and leadership attributes
Oversee and be accountable for regulatory work performed by AIN staff, including global change assessments, state and federal licensure, submission execution, periodic reporting and process enhancements
Partner closely with functional and regulatory leadership to drive strategic alignment across Amgen’s products
Ensure high-quality, timely, and compliant regulatory deliverables
Build and maintain strong partnerships with global functional leaders and internal stakeholders
Serve as a trusted and proactive cross-functional partner

What we offer

Reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment

Director, CMC and Device Regulatory Affairs

The Director, CMC and Device Regulatory Affairs will lead the implementation of ...

Location

Salary:

220000.00 - 240000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

Advanced degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field
Minimum of 10 years of industry experience
At least 6 years in CMC regulatory for biologics and/or drug-delivery combination products
Experience with late-stage development (Phase 3) and/or BLA/MAA/Notified Body submissions preferred
Proven track record of leading cross-functional submission teams and successful regulatory submissions
Strong knowledge of global regulatory requirements (FDA, EMA, ICH)
Excellent communication, leadership, and project management skills
Detail-oriented with ability and desire to work in a fast-paced, nimble, hands-on, team-oriented, biotech environment
Up to 15 – 20% travel is required, including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year
Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient, and Egoless

Job Responsibility

Develop and implement global CMC and device regulatory strategies for assigned program(s)
Lead the preparation and review of CMC and device regulatory submissions (e.g., INDs, CTAs, BLAs, MAAs, Notified Body submissions)
Collaborate with Technical Operations, Quality, Clinical, and Regulatory teams to ensure regulatory requirements are integrated into product development plans
Identify regulatory risks associated with product development and propose mitigation strategies
Manage interactions with regulatory agencies and notified bodies, including meeting preparation and responses to queries
Review CMC-related changes for potential impact on global submissions, provide regulatory impact assessments, and work with project teams to ensure timely reporting of changes
Archive and maintain regulatory submissions and correspondences in Apogee’s regulatory information management system
Contribute to the optimization and implementation of processes and procedures, commensurate with departmental and company growth

What we offer

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
Three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

Fulltime

Associate Director, Quality Control Technical Services

Beam Therapeutics is a biotechnology company committed to establishing the leadi...

Location

United States , Cambridge

Salary:

185000.00 - 225000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Advanced degree (MS, Ph.D) in Chemistry, Biochemistry, Molecular Biology, or a related scientific discipline, with 8+ years of relevant industry experience in Quality Control, Analytical Development, or CMC within biologics, cell therapy, or gene therapy
Extensive hands-on experience with ex vivo autologous cell therapies, including CD34+ cell-based products, across late-stage development, validation, and/or commercial readiness
Demonstrated technical expertise in cell handling and testing methodologies, including functional and potency assays, flow cytometry, NGS-based assays, and separation sciences. Experience with analytical method automation, qualification, and validation is strongly preferred
Proven understanding of analytical method lifecycle management, including method transfer, qualification, validation, performance monitoring, remediation, and comparability, particularly for late-stage and commercial products
Strong working knowledge of US and EU regulatory expectations (e.g., FDA/CBER, EMA, ICH, USP) applicable to cell and gene therapy CMC, with the ability to apply guidance in a phase-appropriate and inspection-ready manner
Direct experience supporting regulatory submissions (INDs, BLAs, amendments, post-approval changes) for cell and gene therapy products, including specifications, method validation reports, and responses to health authority questions
Demonstrated ability to lead and influence cross-functional program teams, partnering effectively with CMC, Manufacturing, Analytical R&D, Quality Assurance, and Regulatory Affairs in a fast-paced, matrixed environment
Strong communication and leadership skills, with a track record of clearly articulating technical strategies, aligning stakeholders, and driving decisions across functions and with external partners
Documented success in driving complex, program-critical initiatives to completion on time and within budget, including managing dependencies, risks, and priorities across multiple workstreams
Highly developed organizational, analytical, and problem-solving skills, with the ability to interpret complex datasets, assess risk, and translate data into actionable QC and CMC strategies

Job Responsibility

Lead and influence QC CMC strategy in partnership with cross-functional CMC teams for master cell banks (MCBs), plasmids, and mRNA drug substance and critical materials, supporting both ex vivo and in vivo therapy programs across development and commercialization
Define and execute the QC testing, method strategy, and technical execution to enable next-generation autologous cell therapy manufacturing processes, including analytical readiness for process validation, comparability, and technology transfer
Own and coordinate analytical method transfer, qualification, and validation activities across internal and external QC laboratories, ensuring compliant, phase-appropriate, and inspection-ready execution
Establish and maintain analytical control strategies by tracking and trending in-process, release, and stability data, collaborating with statisticians and program teams to define and justify specifications for MCBs, plasmids, mRNA, and autologous cell therapy products
Define and oversee stability strategies and programs for MCBs, plasmids, mRNA, and ex vivo cell therapy products, ensuring alignment with regulatory expectations and lifecycle needs
Lead analytical method lifecycle management for late-stage and commercial ex vivo portfolio, including method performance monitoring, remediation, comparability activities, and continuous improvement
Drive the internalization of validated mRNA analytical methods into Beam's North Carolina Quality Control laboratory, strengthening internal capabilities and supporting long-term commercial supply
Author and review Quality System documentation, including SOPs, Change Controls, and CAPAs, to support method implementation, lifecycle changes, and inspection readiness
Partner with Regulatory Affairs-CMC to author, review, and coordinate CMC sections of regulatory submissions, including specifications, method validation reports, and responses to agency queries
Ensure QC visibility and alignment on regulatory interactions, including tracking agency questions, commitments, post-approval requirements, and method introduction or change strategies

Fulltime

Global Regulatory Director Lead – Obesity & Related Conditions (Type II Diabetes)

The Director, Global Regulatory Lead (GRL) provides strategic regulatory leaders...

Location

United States

Salary:

189632.45 - 256561.55 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 4 years of regulatory experience OR Master's degree and 7 years of regulatory experience OR Bachelor's degree and 9 years of regulatory experience
8–10+ years of global regulatory experience, with demonstrated leadership of regulatory strategy for programs in Type II diabetes, obesity, metabolic disorders, endocrinology, cardiovascular risk, or related therapeutic areas
Strong scientific literacy in metabolism, energy balance physiology, hormone signaling pathways, adiposity biology, and associated clinical endpoints
Experience developing global submissions and leading interactions with FDA, EMA, and other regulatory bodies
Demonstrated success leading GRTs and influencing governance bodies on complex regulatory and clinical development issues
Proven ability to translate metabolic science into clear regulatory strategy and decision-making frameworks
Strong communication and negotiation skills, with the ability to guide teams through ambiguous or high-stakes situations
Experience in real-world evidence strategy, long-term outcome measures, and chronic disease regulatory considerations is a plus

Job Responsibility

Develop and lead global regulatory strategy for obesity and metabolic disease programs with focus on Type II diabetes, grounded in a strong understanding of metabolic biology, endocrine pathways, adiposity-related physiology, and cardiometabolic risk science
Integrate clinical, nonclinical, CMC, and safety evidence into cohesive regulatory recommendations, accounting for regulatory precedent in obesity and related conditions
Lead the creation of the Global Regulatory Strategic Plan (GRSP), including risk assessment, regulatory scenario planning, and evaluation of novel/expedited pathways
Advises on key clinical development elements relevant to obesity programs—study designs, chronic treatment safety, cardiovascular outcomes evaluation, metabolic biomarker selection, pediatric development, and real-world evidence plans
Lead the Global Regulatory Team (GRT) and represent Global Regulatory Affairs and Strategy (GRAAS) on cross-functional teams
Partner closely with Clinical Development, Safety, CMC, Value & Access, Commercial, and regional regulatory colleagues
Translate complex metabolic science into actionable regulatory strategy
Oversee execution of major global regulatory submissions
Ensure consistency, scientific rigor, and clarity across core regulatory documents
Guides the regulatory interpretation of evolving FDA/EMA guidance related to obesity and related conditions

What we offer

Health and welfare plans for staff and eligible dependents
Financial plans with opportunities to save towards retirement or other goals
Work/life balance
Career development opportunities
Comprehensive employee benefits package including Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
Discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

New

Supervisor

We're Popeyes UK&I, a Times Top 100 ranked company / great place to work and Hap...

Location

United Kingdom , Antrim

Salary:

12.75 - 13.25 GBP / Hour

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

Experience as a Supervisor, Team Leader, or Shift Manager in a fast-paced environment (QSR or fast casual dining preferable)
A lead-from-the-front mindset — you’re hands-on and support your team at all times
Passion for people — you know great results come from great teams
Confidence in managing standards, compliance, and food safety
Strong communication skills and the ability to motivate a team
The ability to stay calm, organised, and focused in a busy environment
A hunger to grow and develop — this is your pathway into management

Job Responsibility

Run your shift and lead the team to deliver Popeyes’ outstanding food quality, speed of service, and guest experience standards
Support your management team in hitting performance goals and driving results
Lead pre-shift briefings and keep your team aligned, focused, and energised
Be the role model — set the tone, keep standards high, and lead from the front
Create a fun, inclusive environment where both team and guests feel the energy
Coach, train, and develop your team — building future leaders
Ensure full compliance with food safety (HACCP), health & safety, and company standards
Take ownership of your shift performance — labour, flow, and service
Bring the fun and keep the energy high, the service smooth, and the culture poppin’

What we offer

Hourly rate of £12.75, increasing to £13.25 with £0.50 premium when acting as Duty Manager
£1000 referral bonus
Flexible schedules that work around you
Free meals on shift + discount when your not working
Employee perks including gym + retail discounts, tech scheme
Career development and progression opportunities supported through our Popeyes University dedicated learning platform

New

Care Assistant

Location

United Kingdom , Milton Keynes

Salary:

14.33 GBP / Hour

ExtraCare

Expiration Date

Until further notice

Requirements

Hold a care certificate or willing to undertake a care qualification
Personable, an effective communicator and a team player
Passionate about delivering a quality care service
Flexible with hours

Job Responsibility

Provide all aspects of domiciliary care to our residents including both physical, personal care and support with social activities
Promoting and supporting the physical, emotional and well-being of our residents
Encourage independence and self-belief
Ensure records and documents are completed in line with our policy

What we offer

Golden Hello for All New Care Assistant Starters Of £500! (Criteria Applies)
33 Days Annual Leave (FTE) Pro Rata for Part Time
Enhanced Maternity & Paternity allowance
Enhanced employer pension contribution
Eligible for Blue Light Card discounts
Attendance Reward
Free Life Insurance
Buy And Sell Holiday
Cycle2work Scheme
Free Use of Onsite Gym

Parttime

New

Senior Clinical Research Associate

As a Senior CRA at ICON Plc, you will oversee and manage clinical trial activiti...

Location

Germany , Frankfurt

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a relevant scientific discipline or healthcare-related field
Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements
Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills
Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools
Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment
Willingness to travel as required (approximately 60%)

Job Responsibility

Monitor clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards
Conduct site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution
Collaborate with cross-functional teams to ensure timely and accurate data collection and reporting
Provide training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct
Build and maintain effective relationships with site personnel and stakeholders to facilitate smooth trial operations

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

Select Country

Associate Director, CMC Regulatory Affairs

AbCellera Biologics

Location:
Canada , Vancouver

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
March 05, 2026

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Associate Director, CMC Regulatory Affairs

AbCellera Biologics

Location:Canada , Vancouver

Category:Research and Development

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Job Responsibility:

Requirements:

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Job Posted:March 05, 2026

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