Senior Regulatory Affairs Officer Job at Randstad (Vapi)

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

Senior Regulatory Affairs Specialist

Reporting to the Senior Manager, Regulatory Affairs within the RA Department, th...

Location

United States , St Louis

Salary:

74000.00 - 90000.00 USD / Year

STERIS

Expiration Date

Until further notice

Requirements

Bachelor's Degree
At least 5 years professional experience including regulatory affairs, quality systems, internal auditing, applicable scientific or technical functions
Self-starter with demonstrated organizational, project management, time management and problem-solving skills
Experience working effectively on cross-functional teams
Demonstrated ability to balance multiple high priority responsibilities on-time and effectively
Excellent PC skills, including Microsoft Office applications including Excel, Word and PowerPoint
Understanding of chemical / scientific industry
Experience with internal audit process and quality systems
Experience with Healthcare regulatory support for product assessments, Safety Data Sheet generation, and Customer inquiries

Job Responsibility

Identify regulatory requirements for new products or product enhancements early in the product development cycle
Assure that product registration and maintenance fees are tracked and paid
Gather information to support regulatory submissions. Use this information to prepare regulatory submissions in a complete, thorough format to support STERIS product claims
Review product revision requests to assure compliance with regulatory requirements
Work on product teams to develop regulatory strategy based on regulatory submission requirements
Review and approve labeling and marketing literature
Support Manager, Regulatory Affairs and other Regulatory Affairs staff with all regulatory matters
Provide Regulatory support for product assessments, Safety Data Sheet generation, and Customer inquiries to the Healthcare team
Work with direct Supervisor and senior internal stakeholders to identify key initiatives, which may be affect by present or emerging policies. As part of this, develop and recommend government affairs policy positions to upper management
Other duties as assigned

What we offer

Market Competitive Pay
Extensive Paid Time Off and (9) added Holidays
Excellent Healthcare, Dental and Vision Benefits
Long/Short Term Disability Coverage
401(k) with a company match
Maternity and Paternity Leave
Additional add-on benefits/discounts for programs such as Pet Insurance
Tuition Reimbursement and continued education programs
Excellent opportunities for advancement in a stable long-term care

Fulltime

Senior Risk and Compliance Manager

Senior Risk and Compliance Manager (m/f/d) to build and unite processes across b...

Location

Germany , Berlin

Salary:

Not provided

Project A Ventures GmbH

Expiration Date

Until further notice

Requirements

Several years of experience working in an asset management company, bank, insurance company, or auditing or auditing firm
Professional background in legal, commercial, or business administration, ideally with tax knowledge (including legal, administrative, or banking or insurance qualifications)
Experience in risk management and compliance including ESG knowledge (required) and experience with DORA (desirable)
Strong affinity for numbers, structures, and processes
Business-level proficiency in both German and English

Job Responsibility

Manage risk and compliance processes in a licensed asset management company with more than ten closed-end “Spezial-AIFs”
Strengthen the Risk Management & Regulatory Affairs Department through enhancing reporting and processes in the areas of risk management, ESG compliance, and outsourcing controlling
Actively communicate with external service providers and outsourcing companies, as well as with internal front- and back-office units
Conduct ESG due diligence on investments in portfolio companies while also supporting the Investment Team with ESG-related documentation
Create and continuously maintain SFDR disclosures and ESG policies
Drive the development of new and ongoing risk and compliance reporting
Continuously enhance risk management and regulatory compliance across multiple front and back office units
Be at the interface between Project A and its regulated UK subsidiary

Fulltime

Regulatory Affairs Senior Specialist

Cencora Pharmalex is one of the leading service providers for the Pharmaceutical...

Location

United States

Salary:

Not provided

Cencora

Expiration Date

Until further notice

Requirements

Bachelor’s Degree and 3-5 years’ experience in Regulatory Affairs
or equivalent combination of education and experience
Experience working in the pharmaceutical industry
Ability to prioritize and drive multiple projects
Ability to train and support junior/new colleagues in daily activities
ability to lead small project with clearly defined scope
Understanding of FDA and Canadian Regulatory Affairs procedures, submission formats as well as industry standards and guidelines
Previous hands-on experience with managing and preparing original applications, amendments, supplements, annual reports, etc. for various application types including IND/CTA, ANDA/NDS/NDA/BLA
Ability to maintain confidentiality and responsive to client needs
Ability to adapt under regularly changing conditions

Job Responsibility

Manages the preparation, assembly, publishing, and submitting of US and Canadian regulatory applications on behalf of PharmaLex clients
Supports key regulatory affairs consultants, by providing expertise and innovative solutions to clients and internal teams on regulatory strategy, process, filing, best practices, etc. for a broad range of product types and indications
Drafts and manages regulatory submissions
Drafts and manages drug listing submissions, establishment registration submissions and preparation of SPL files
Coordinates regulatory fee payments on behalf of client
Maintains knowledge of changing regulatory requirements and advises teams as appropriate (Regulatory Intelligence)
Liaises with regulatory authorities on behalf of clients (e.g., US Agent)
Builds, develops and maintains working relationships with clients
Conducts issue resolution, communicates with the client and their functional areas to ensure that all issues are resolved in a compliant manner
Performs basic document management tasks including file transfer, storage, tracking, and archival

What we offer

medical
dental
vision care
comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness
support for working families
backup dependent care
adoption assistance
infertility coverage
family building support
behavioral health solutions

Fulltime