Regulatory Affairs & Quality Assurance Associate Job at New York Embroidery Studio (Brooklyn)

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

New

Senior Regulatory Affairs Associate - CMC biologics/vaccines

As part of Parexel Consulting, you will play a vital role in helping biopharmace...

Location

Serbia

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

University-level education, preferably in Life Sciences, or equivalent by experience
Previous experience in regulatory affairs, particularly related to technical/CMC/quality, within the pharmaceutical industry
Strong understanding of CMC and post-approval regulatory requirements
Experience in writing CMC (technical) sections of regulatory documents such as registration files or variations
Knowledge of biological or vaccines processes
Background in validation/Quality Assurance/production in the pharmaceutical industry, with experience in preparing regulatory documentation
Understanding of qualification/validation principles
Proficiency in Word, PowerPoint, Excel, and experience with Veeva Vault is valued
Team spirit, flexibility, accountability, and organizational skills
Fluent in English (written and spoken)

Job Responsibility

Develop submission strategies and plans for post-approval CMC activities such as variations, renewals, market expansions, and annual reports
Assess change controls and provide regulatory assessments of quality changes in production and quality control
Review study reports from the quality control and production departments to ensure compliance with regulatory requirements
Coordinate submission preparation with various departments including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and local companies
Write and/or review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities
Manage projects within all Regulatory Information Management systems, ensuring the maintenance of worldwide submissions
Identify, escalate, and mitigate risks associated with regulatory procedures and activities

What we offer

flexibility of working remotely
supportive and dynamic team
challenging assignments
mentorship from experienced regulatory professionals

Fulltime

Director of Quality Assurance, Clinical

Responsible for leading in the development, implementation and maintenance of QA...

Location

United States , Berkeley

Salary:

220000.00 - 235000.00 USD / Year

Caribou Biosciences

Expiration Date

Until further notice

Requirements

Undergraduate or graduate degree(s) in Biological Sciences, Chemistry, or related Science discipline
At least 15 years of experience in clinical quality assurance (GCP, GLP and PV) in cell & gene therapy/biotechnology and/or pharmaceutical industry
Experience working in biologics is strongly preferred
Subject Matter Expert (SME) working knowledge on current interpretation/implementation of United States Code of Federal Regulations, ICH Guidelines and other local government regulatory requirements governing clinical research
Proven track record in developing and implementing quality systems and processes in a clinical setting
Expertise in creating and executing audit plans outlining all service providers (vendor) audits, clinical investigator site audits, CSV audits and process audits
Advanced knowledge of Quality Assurance principles, concepts, industry practices, and standards
Prior GLP experience with quality oversight and auditing studies/vendors (preferred)
Excellent verbal and written communication skills
Ability to lead cross-functional teams and independently prioritize work

Job Responsibility

Compliance Oversight: Ensure that all clinical trial activities comply with guidelines and international regulations (e.g., ICH-GCP and ICH-PV), and applicable laws
Documentation Review: Conduct thorough reviews of study-related documentation, including protocols, investigator brochures, informed consent forms, and CSRs, to verify compliance with GCP requirements
Provide Clinical Quality Assurance (GCP) strategic and technical leadership and Subject Matter Expertise (SME) to clinical study teams
Partner with the teams to effect appropriate and timely documentation of quality event management, including CAPA plans in support of product pipeline
Plan and oversee activities in support of regulatory submissions and inspections
Lead GCP Inspection Readiness efforts, ensure implementation and prepare internal and external teams for Pre-Approval Inspections (PAI)
Implement, monitor, and promote best practices of all Quality Assurance Systems to ensure compliance with relevant FDA, EU and ROW regulations/directives/requirements and ICH guidelines
Quality Management System (QMS): Maintain and enhance Caribou’s QMS by implementing processes and procedures that ensure consistent adherence to GCP, GLP and PV standards throughout the clinical trial lifecycle
Develop and implement the appropriate suite of Standard Operating Procedures (SOPs), quality manuals, policies, and other related quality documents
Ensure that these systems are effectively communicated, understood, and followed by relevant stakeholders

What we offer

Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees
Generous paid vacation time, in addition to company-observed holidays
Excellent medical, dental, and vision insurance
401(k) retirement savings plan, which includes matching employer contributions
Employee stock purchase plan (ESPP)
Tuition reimbursement program

Fulltime

Engineering Validation Associate

The Engineering Validation Associate reports to the Commissioning Qualification ...

Location

Ireland , Cork

Salary:

Not provided

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

In collaboration with plant support functions, assist with planning, set up and implementation of Analytical Instrument Qualification, Facilities, Utilities, Equipment (FUE) Qualification and Process Validation programs
Execute (protocol generation, execution, and final package preparation) Validation activities related to the various coordinating the worldwide movement of our drugs to patients
In collaboration with plant support functions, assist with planning, set up and implementation of Analytical Instrument Qualification, Facilities, Utilities, Equipment (FUE) Qualification and Validation disciplines e.g. FUE Qualification, CSV, New Product Introductions and Change Control
Develop validation plans for specific system implementation projects
Support the establishment of site validation policies, through development, generation and implementation of site validation master plans, guideline documents and standard operating procedures
Prepare and track to completion any assigned change requests, deviations, quality events and associated CAPAs
Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance
Assistwithpreparationofregulatoryfilings andparticipation during regulatory inspections/partner audits
Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured by BioMarin, validation techniques/approaches and systems utilized at BioMarin
Lead and represent validation in multi-departmental meetings and project teams

New

Regulatory Affairs Consultant - CMC vax/bio (home or office based)

As part of Parexel Consulting, you will play a vital role in helping biopharmace...

Location

United Kingdom

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

University-level education, preferably in Life Sciences, or equivalent by experience
Previous experience in regulatory affairs, particularly related to technical/CMC/quality, within the pharmaceutical industry
Strong understanding of CMC and post-approval regulatory requirements
Experience in writing CMC (technical) sections of regulatory documents such as registration files or variations
Knowledge of vaccines or biological processes - must
Background in validation/Quality Assurance/production in the pharmaceutical industry, with experience in preparing regulatory documentation
Understanding of qualification/validation principles
Proficiency in Word, PowerPoint, Excel, and experience with Veeva Vault is valued
Team spirit, flexibility, accountability, and organizational skills
Fluent in English (written and spoken)

Job Responsibility

Develop submission strategies and plans for post-approval CMC activities such as variations, renewals, market expansions, and annual reports
Assess change controls and provide regulatory assessments of quality changes in production and quality control
Review study reports from the quality control and production departments to ensure compliance with regulatory requirements
Coordinate submission preparation with various departments including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and local companies
Write and/or review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities
Manage projects within all Regulatory Information Management systems, ensuring the maintenance of worldwide submissions
Identify, escalate, and mitigate risks associated with regulatory procedures and activities

What we offer

Flexible work arrangements

Fulltime

Senior Manager, Central Regulatory Affairs

The Sr. Manager - Central RA is a pivotal senior leadership role based out of Ba...

Location

India , Bangalore

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Advanced degree in Pharmacy, Life Sciences, Biotechnology, Regulatory Affairs, or related discipline
12+ years of progressive experience in global regulatory affairs within the pharmaceutical, biotechnology, or medical device industry, with significant people management and team development
Expert knowledge of global regulatory requirements and guidelines (FDA, EMA, TGA, MHRA, etc.), with a strong track record of successful regulatory submissions and approvals
Proven leadership skills with the ability to influence and collaborate effectively across diverse global teams and stakeholders
Strategic thinker with the ability to navigate complex regulatory challenges and drive regulatory initiatives that support business growth and compliance objectives

Job Responsibility

Develop and implement global regulatory strategies for Baxter products (both Drugs and Devices) aligned with business objectives to support product lifecycle spanning timely Initial /Geo-expansion/ Change controls and Variations registrations enabling speedy commercialization across diverse markets
Drive transformation initiatives to improve regulatory processes and ensure compliance with changing regulatory requirements
Collaborate with cross-functional teams to identify opportunities for innovation and implement solutions
Lead the preparation and submission of regulatory documents, including lifecycle management submissions, to regulatory authorities globally
Ensure that all submissions are accurate, complete, and compliant with regulatory requirements
Engage and collaborate with cross-functional teams, including R&D, Quality, and Manufacturing, to gather necessary information and ensure alignment
Oversee the preparation, review, and submission of both Drug and Device Lifecycle management regulatory filings (e.g., Initial and Geo-expansion registrations, change controls, Variations, Tender support, Acquisition Integration /Divestiture related Legal Entity name changes etc.) to health authorities across global markets
Ensure timely approvals and compliance with regulatory standards and post-market requirements across multiple jurisdictions
Establish and maintain standardized regulatory processes, procedures, and documentation within Central RA to drive operational efficiency and regulatory compliance across GRA
Generate future readiness with implementation of best practices and continuous improvement initiatives to optimize regulatory operations and ensure consistency across regions for registrations, Change Control Management, tender Support, Geo-expansion/Initial registrations

Regulatory Project Manager

At GSK, we’re constantly developing new products and improving our established m...

Location

Poland , Poznan; Warsaw

Salary:

236250.00 - 393750.00 PLN / Year

GSK

Expiration Date

Until further notice

Requirements

Advanced degree (Master's or above) in Pharmacy, Biotechnology, Biology, Chemistry/Biochemistry or other closely related medical/life science field
Strong experience in CMC Regulatory Affairs within pharmaceutical industry or research organization
Extensive expertise in regulatory strategy planning, dossier preparation (CTD Module 1-3), technical dossier review and in all associated CMC regulatory aspects
Sound understanding of the pharmaceutical industry, drug development environment, regulatory processes and ICH guidelines and requirements, including EU regulatory framework
Exceptional flexibility, analytical thinking and growth mindset
Excellent interpersonal skills
including clear and effective written and verbal communication, and the ability to build strong relationships across a diverse, large organization
English writing skills
Excellent organizational skills, ability to handle multiple tasks, prioritize effectively and deliver high quality output under imposed deadlines, with a strong attention to detail (with emphasis on accuracy and completeness)

Job Responsibility

Take ownership for multiple complex CMC regulatory submissions, including planning, coordination and execution, to support applications for marketing authorizations, lifecycle activities and maintenance of registered products across Vaccines portfolio, in accordance with the applicable regulatory and scientific standards
Manage multiple project assignments simultaneously, including CMC variations and handling Health Authority Questions (HAQs) for Finished Products, Intermediates, and Active Pharmaceutical Ingredients for Vaccines products (i.e. largely involving updates to the CTD Module 3, Quality section of the dossiers)
Identify risks associated with submission data and information package
and support the development of mitigation strategies
Collaborate closely with cross-functional teams, such as Global Regulatory Lead’s team, Global Supply Chain (GSC), Quality Assurance (QA), Local Operating Companies (LOCs), and third Parties to build regulatory CMC submissions and maintain strong relationships, including with senior stakeholders
Identify improvement opportunities for CMC Regulatory processes, policies, instructions and systems, developing and implementing simplified working practices and procedures to enhance efficiency and quality
Serve as Subject Matter Expert (SME) for CMC Regulatory Affairs, mentoring and guiding team members, while sharing best practices to build capability and knowledge within the CMC Regulatory teams and other impacted functions

What we offer

private healthcare
additional paid days off
life insurance
private pension plan
fully paid parental leave & care of family member leave

Fulltime

New

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

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Regulatory Affairs & Quality Assurance Associate

New York Embroidery Studio

Location:
United States , Brooklyn

Category:
Quality Control

Contract Type:
Employment contract

Salary:

Job Description:

Job Responsibility:

Requirements:

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Additional Information:

Job Posted:
May 20, 2026

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Regulatory Affairs & Quality Assurance Associate

New York Embroidery Studio

Location:United States , Brooklyn

Category:Quality Control

Contract Type:Employment contract

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:May 20, 2026

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