Document Submissions Associate Job at Clipboard Health

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

Associate Director, Regulatory

We are seeking an experienced and highly motivated professional to join our team...

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 8 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
stock option plans

Accounting Compliance & Special Projects Manager

Oversee and coordinate a high volume of time‑sensitive, compliance‑driven accoun...

Location

United States , Washington

Salary:

90000.00 - 120000.00 USD / Year

Beacon Hill

Expiration Date

Until further notice

Requirements

Strong foundation in accounting operations
Solid understanding of the audit and tax process
Ability to lead staff and drive structure, clarity, and accountability
Experience building repeatable processes and maintaining rigorous documentation standards
Experience supporting cross-functional accounting initiatives

Job Responsibility

Coordinate federal, state, and local tax filings for community associations, partnering with auditors and tax preparers
Manage compliance workflows, including gathering documentation, preparing approval packages, tracking deadlines, and ensuring timely submission
Maintain regulatory portals, system access, and association registrations
Coordinate tax-related payments, property tax tracking, allocations, and true‑ups with accounting teams
Support annual budget preparation, template updates, fee validation, and QA reviews
Oversee annual audit timelines, request lists, document submissions, draft coordination, and audit adjustment entries
Assist with association onboarding/offboarding, including GL mapping, banking review, balance imports, and data transfer
Build and maintain trackers, calendars, and checklists to improve process visibility and reduce last‑minute escalations
Document processes, identify workflow bottlenecks, and recommend operational improvements
Lead and support a team of accounting staff to ensure timely execution of compliance deliverables

Fulltime

New

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

Fulltime

New

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

Senior Medical Writer - FSP

As a Medical Writer at Parexel, your strong scientific knowledge, writing skills...

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Bachelor's degree in Life Sciences/Health Related Sciences or equivalent
Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP
Extensive clinical/scientific writing skills
Scientific background essential
writing experience includes multiple clinical documents: study reports, study protocols, or CTD documents or similar
Advanced word processing skills, including MS Office (expertise in Word)
software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel)
Fluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation
Excellent interpersonal, verbal, and written communication skills
Ability to consistently produce documents of high quality

Job Responsibility

Author Clinical Documents: Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, and integrated summaries of safety and efficacy
Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input
Follow required standard operating procedures (SOPs), templates, guidelines, regulations, client instructions and other processes, as applicable
Perform literature searches/reviews as necessary to obtain background information and training for development of documents
Review statistical analysis plans and mock statistical output to determine appropriateness of content/format for clinical writing
Quality Control: Ensure that all work is complete and of high quality prior to team distribution or shipment to client
Confirm data consistency and integrity across the document
Prepare documents for publishing readiness, when applicable
Ensure document structure, content, and style adheres to FDA/EMA or other appropriate regulatory guidelines, and comply with departmental, corporate or client SOPs and style guidelines, as applicable
Provide suggested alternative content when contributors provide content that does not meet document needs

What we offer

Foster a culture of inclusivity, collaboration, and support
Continuous learning from being mentored to job shadowing, job rotation, and stretch assignments, as well as becoming a mentor or leading a team
Development and promotion based on global standards and your personal development plan
Supportive and inclusive environment
Career growth and development
Mentorship
Flexible work
Diverse projects
Culture of excellence
Global exposure

HR & Office Administrator

This part‑time maternity cover position provides standalone HR administrative su...

Location

United Kingdom , Basingstoke

Salary:

13.50 GBP / Hour

Office Angels

Expiration Date

Until further notice

Requirements

Previous experience in a similar HR administrative role
Intermediate proficiency in Microsoft Word and Excel
Highly organised, detail‑oriented and able to manage multiple priorities independently
Strong communication skills, both written and verbal, with the ability to draft professional business correspondence
Professional, credible and able to handle confidential information with integrity
Good general education
Must have the right to work in the UK and provide appropriate documentation
Must undergo a Baseline Personnel Security Standard (BPSS) check
Must be eligible and willing to undergo National Security Vetting, including: A minimum of 5 years continuous UK residency
Meeting nationality restrictions where applicable

Job Responsibility

Maintain the HR electronic filing system and handle all HR correspondence
Administer all employee lifecycle documentation (starters, changes, leavers) in line with company processes
Ensure timely communication with payroll regarding new starters, leavers and monthly salary changes
Coordinate recruitment activity, acting as the first point of contact for applicants and recruitment agencies. Schedule interviews and support onboarding requirements for new starters
Support the coordination and administration of company benefit schemes
Manage employee data in line with GDPR and best data protection practices
Support the Security Officer with vetting applications and associated documentation
Ensure timely submission of vetting applications and chase outstanding information
Arrange internal meetings and company events as required
Maintain consultant time‑recording information in Clockify, including project codes, new starters and leavers

What we offer

Potential for the role to become permanent

Parttime

New

Senior Associate Regulatory Affairs - Clinical Studies

The Local Senior Associate Regulatory Affairs provides high-level regulatory lea...

Location

Mexico , Mexico City

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree in health sciences or related field and experience in Clinical Regulatory Affairs in Mexico in similar positions on a big pharmaceutical company
Bachelor’s degree in health sciences or related field and 2 years of experience in Clinical Regulatory Affairs in Mexico in similar positions on a big pharmaceutical company
Associate’s degree in health sciences or related field and 6 years of experience in Clinical Regulatory Affairs in Mexico in similar positions on a big pharmaceutical company
Proficiency in English, both in oral and written communication

Job Responsibility

Independently handle and maintain complete, accurate, and traceable regulatory documentation supporting clinical protocol approvals for initial and lifecycle management protocols submitted via DIGIPRiS, in compliance with NOM-012-SSA3-2012, applicable COFEPRIS regulations, and Amgen policies
Document and implement local regulatory strategies based on current health legislation, COFEPRIS guidelines, and formal regulatory agreements, ensuring alignment with approved submission pathways
Ensure consistency application of Good Clinical Practice (GCP) requirements across regulatory submissions and Health Authority communications
Systematically assess, document, and mitigate regulatory risks, including communication and escalation within Local Study Teams (LSTs) and relevant governance forums
Maintain detailed collaboration with Global Regulatory, Clinical Operations, Quality, Safety, Medical, and Legal functions to support regulatory compliance and inspection readiness
Define and implement local regulatory strategies based on health legislation expertise and interpretation of COFEPRIS guidelines, agreements, and evolving regulatory criteria
Independently assess regulatory risks and determine appropriate submission pathways and documentation approaches to support timely protocol approvals
Proactively assess, communicate, and mitigate regulatory risks impacting timelines and compliance during the internal LST (Local Study Team)
Collaborating with Global Regulatory, Clinical Operations, Quality, Safety, Medical, and Legal partners
Apply regulatory and ethical requirements, including CONBIOÉTICA guidelines, to support compliance with local Ethics Committee expectations for protocol, Inform Consent Form and other subject material or information

What we offer

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

Fulltime

Document Submissions Associate

Clipboard Health

Location:

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
February 17, 2026

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