Director, Global Regulatory Affairs (Submission Project Management) Job at Kailera Therapeutics (Waltham)

Director, Regulatory Labeling

Beam is seeking a Director of Regulatory Affairs – Advertising, Labeling, and Pr...

Location

United States , Cambridge

Salary:

210000.00 - 260000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

BS required
an advanced degree (i.e. MS, PharmD, PhD, MD) is a plus
A minimum of 6 years of experience working in Regulatory Affairs Advertising, Labeling, and Promotion
ideally 15 plus years in the biotech industry with at least 8 years in regulatory affairs
Record of success with interactions with Regulatory Agencies and Health Authorities as part of label negotiations and label updates
Comprehensive knowledge of US and global regulatory procedures and practices
Extensive experience with regulatory documents and filings (IND, CTA/IMPD, BLA, MAA, PIP)
Strong strategic thinking and problem-solving skills
Experience in representing programs to internal and external stakeholders
Ability to develop collaborative working relationships internally as well as externally with physicians, expert consultants, and contracted vendors

Job Responsibility

Lead the creation, review, and approval of critical regulatory labeling documents including Core Data Sheet and Regional Labels for Beam hematology programs in alignment with Target Product Profiles
Lead labeling negotiations between Beam and health authorities as part of marketing authorization applications
Create regulatory labeling processes and associated SOPs, Work Instructions, and any other required documentation
Represent Regulatory Affairs as part of the Promotional Review Process
Incorporate the evolving global regulatory requirements and guidance's with respect to gene editing and gene therapy, rare disease, and prescription drug labeling
Provide innovative regulatory approaches, solutions and guidance to cross-functional teams while mitigating regulatory risks
Guide and assist on the planning, preparation, writing and submission of regulatory documentation
Manage project plans and timelines to ensure all projects are prioritized appropriately and milestones and goals are met on time
Provide regulatory due diligence as required
Supervise and mentor direct reports

Fulltime

Senior Director, Clinical and Regulatory Writing

The Senior Director, Clinical and Regulatory Writing will serve as a strategic l...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Advanced degree in life sciences (M.D., or PharmD preferred)
MS, PhD with significant clinical pharmacology writing experience will be considered
12+ years of progressive experience in regulatory or scientific/medical writing in the biopharmaceutical industry, including 5+ years in a leadership role
Demonstrated experience developing content for major global regulatory submissions (e.g., IND, BLA, MAA), preferably in cell or gene therapy
Strong understanding of drug development processes, regulatory frameworks (FDA, EMA, ICH), and clinical trial documentation requirements
Exceptional writing, editing, and analytical skills with the ability to convey complex scientific data clearly and persuasively
Proven leadership capabilities, including team development, cross-functional collaboration, and vendor management
Proficiency in Microsoft Office Suite, document management systems (e.g., Veeva Vault), and electronic publishing tools
Strong project management skills with the ability to prioritize competing demands in a fast-paced, deadline-driven environment
Collaborative mindset with the ability to influence and guide stakeholders across disciplines and levels of seniority

Job Responsibility

Lead the clinical writing function in the development, review, and approval of regulatory documents to support global submissions (e.g., INDs, IMPDs, BLAs, MAAs, Orphan Drug Applications, Investigator Brochures, protocols, clinical study documents, PSPS/POIPs, Prime, RMAT)
Lead cross-functional content planning of regulatory submission modules, including data integration and interpretation, and ensuring consistency in strategic messaging for dossiers, meeting packages and responses to health authorities
Translate complex technical data from clinical and biostatistics teams into scientifically accurate, submission-ready documentation
Manage external consultants and contractors as needed to support Cabaletta submissions reviews, authoring, if needed, and gap analyses
Mentor, train, and manage a team of medical/regulatory/technical writers or cross-functional contributors in document development
Develop and implement strategic plans for medical writing activities, aligning them with clinical development, regulatory affairs, and overall business goals
Drive process improvements and develop standard practices for efficient, compliant and high-quality document delivery
Collaborate with Clinical Operations and external CROs to ensure inspection readiness of clinical trial documentation, including informed consents, study manuals, and IRB/IBC responses

What we offer

health and retirement, PTO, and stock option plans

New

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

New

Director Global Regulatory Affairs

Lead global regulatory strategy and shape the future of cancer innovation. Procl...

Location

Germany , Mainz

Salary:

Not provided

Proclinical

Expiration Date

Until further notice

Requirements

Strong expertise in global reg. affairs, particularly within the oncology field
Proven ability to lead reg. strategies and act as a key contributor on project teams
Comprehensive knowledge of reg. submission processes and requirements
Excellent communication and collaboration skills to work effectively with cross-functional teams
Ability to manage multiple priorities in a fast-paced environment
Flexibility to work remotely within Germany or the UK, with adherence to local contract regulations

Job Responsibility

Lead global reg. strategies for oncology programs, ensuring alignment with organizational goals
Act as the primary reg. representative on project teams, providing expert guidance and input
Develop and execute reg. plans to support product development and approval processes
Collaborate cross-functionally with internal teams and external stakeholders to ensure compliance with reg. requirements
Prepare and review reg. submissions, including clinical trial applications and marketing authorization dossiers
Stay updated on global reg. trends and changes, particularly in oncology, to inform strategic decisions

Fulltime

Senior Director, Drug Substance Development and Manufacturing

Lead and oversee all outsourced drug substance manufacturing operations. Reporti...

Location

United States , Waltham; San Diego

Salary:

210000.00 - 270000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

Minimum of 10+ years of progressive, relevant experience in drug substance development and manufacturing
Deep expertise in both synthetic and recombinant manufacturing approaches
Hands-on experience with the synthesis and manufacturing of peptides is mandatory
Demonstrated track record in managing clinical-scale supply, process characterization and optimization, technical transfers, and process validation activities
Sound technical skills in applying scientific principles to complex process design, implementation, and successful technology transfer
Solid knowledge of current Good Manufacturing Practices (cGMPs), Quality systems, and global regulatory requirements (e.g., FDA, EMA)
Proven experience with the drafting, review, and authoring of CMC sections for major global regulatory submissions (e.g., IND, NDA, MAA)
Exceptional solution-based critical thinking skills and the ability to operate with a keen sense of urgency and an entrepreneurial spirit
Demonstrated ability to ensure accountability of self and others, coupled with strong detail-orientation to proactively identify and mitigate risks and issues
Ability to strategically contribute to and manage multiple concurrent projects

Job Responsibility

Direct and lead all process development, scale-up, technology transfer, and validation activities for peptide drug substance manufacturing across all Contract Development and Manufacturing Organizations (CDMOs)
Establish and drive continuous improvement initiatives focused on enhancing manufacturing efficiency, enabling cost reduction, and establishing strategic redundancies across the CDMO network
Define the long-term vision for manufacturing by maintaining a deep knowledge of industry trends, technological advancements, green manufacturing processes, and emerging regulatory changes
Manage and enforce CDMO performance against key project timelines, deliverables, and costs
Lead the negotiation and execution of complex technical agreements and work orders with CDMO partners
Oversee budget planning and forecasting for all outsourced drug substance manufacturing activities
Serve as the strategic lead for drug substance activities, driving seamless collaboration across Analytical Development, Formulation, Quality Assurance, and Regulatory Affairs
Oversee the preparation and completion of drug substance modules (e.g., Module 3) for all regulatory dossiers (e.g., IND, NDA)
Direct the preparation and final authorship of high-quality technical reports, executive summaries, and presentations to effectively communicate results and progress to internal leadership and external stakeholders

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

New

Shop Foreman - Millwork

Seeking an experienced Millwork Shop Foreman to join our clients team and overse...

Location

United States , Montgomery County

Salary:

65000.00 - 75000.00 USD / Year

Blueprint Staffing

Expiration Date

Until further notice

Requirements

Minimum of 5 years of supervisory shop experience (preferred)
Proficient in operating CNC machinery, including Holzher 7225 five-axis machine center, Holzher edgebander, and Koch Sprint Base Line boring machine
Strong leadership and communication skills
Ability to instruct team members on machinery operation as needed
Excellent organizational and multitasking skills to handle a deadline-oriented environment

Job Responsibility

Maintain high levels of quality and productivity in all aspects of shop operations
Provide direct supervision to the fabrication team, ensuring timely delivery of products in good condition
Ensure cleanliness and organization of the shop, both inside and outside, while maintaining adequate stock levels
Oversee the maintenance and proper functioning of all shop equipment
Foster a safe work environment by maintaining compliance with safety regulations and effectively multitasking in a fast-paced setting

What we offer

Vacation & Holiday Pay
401K
Health Insurance Benefits Available

Fulltime

New

Legal Consultant

We are currently seeking a Legal Consultant with experience in Cryptocurrency / ...

Location

Hong Kong , Hong Kong

Salary:

Not provided

Axiom Law

Expiration Date

Until further notice

Requirements

Circa 5–10 years’ PQE
Minimum of 2 years’ experience in 1) cryptocurrency related business
2) payment regulatory/ financial services regulatory & licensing
Open to both law firm/in-house experience
Fluent in English

Job Responsibility

Work closely with our global client to provide legal support on licensing applications for the payment/ crypto business
Provide legal support relating to payment/crypto products
Liaise with internal stakeholders on new product launches and regulatory strategy
Navigate regional regulatory frameworks and licensing processes, and keep abreast of developments

What we offer

Medical
Dental
Professional development resources
Learning and development programs

New

Superintendent

Cleveland Construction is seeking an experienced Superintendent, with the flexib...

Location

United States , Lafayette, LA or Kansas City, KS

Salary:

Not provided

Cleveland Construction

Expiration Date

Until further notice

Requirements

Have a good working knowledge of all project documents, including specifications, plans, submittals, subcontracts, shop drawings, and any other project specific documents
Must be able to clearly communicate by verbal, written, or electronic means to all members of the project team
Demonstrated leadership skills and strategies for organizing all scopes, people, material, tools and equipment to manage the project successfully
Proficiency in electrical, mechanical, and structural systems
Advanced knowledge of OSHA requirements and how to successfully execute an OSHA site visit
Basic knowledge of Microsoft Office Suite and related construction software
Basic knowledge of uploading and managing web based document storage
Preferred four (4) year degree in a construction-related curriculum or equivalent field experience
Minimum of 5-7 years of field experience in the commercial construction industry
OSHA 30 preferred

Job Responsibility

Assist in planning, scheduling, and directing activities of subcontractors and workers
Ensure work conforms to specifications and adheres to schedules
Coordinate site safety program following company safety manual
Implement and enforce the company's safety policies, site specific safety programs, and promote a safety culture on the jobsite at all times
Plan, direct, manage, oversee, and document all daily activities on the project site
Implement, manage, and maintain a worker orientation program for all new workers on the project
Enforce the company's public safety program ensuring the safety of all non-construction related people
Implement, maintain, update, and communicate the project schedule
Implement, maintain, and enforce the company's quality control plan
Coordinate all required field inspections and maintain the inspection log

What we offer

Medical, dental, vision, 401K, training and development, opportunity for advancement and corporate support for field operations

Fulltime

Director, Global Regulatory Affairs (Submission Project Management)

Kailera Therapeutics

Location:
United States , Waltham

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 03, 2026

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