Senior Regulatory Affairs Officer Job at SRG (Edinburgh)

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 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

Hub Labeling Manager

The Manager is responsible for preparation of LPDs, associated LLDs and PLDs for...

Location

United Kingdom , Tadworth, Surrey

Salary:

40000.00 - 45000.00 GBP / Year

SRG

Expiration Date

Until further notice

Requirements

Life sciences or pharmacy graduate, or equivalent relevant professional experience
Ability to develop positive relationships across cultures and locations
Strong attention to detail and problem‑solving skills
Demonstrated technical aptitude and ability to learn new software quickly
Ability to quickly learn regulations and standards
Hands‑on registration experience in development, maintenance, or commercialization within Regulatory Affairs - ideally from a country office or regional regulatory perspective, especially understanding the implications of a CDS on LPDs
Ability to understand and manage regulatory implications of product strategy relating to labelling
Knowledge of global/regional regulatory guidelines, requirements, and clinical variations
Strong project management and analytical skills
Proficient in systems use consistent with business expectations

Job Responsibility

Monitors system data integrity and performs quality checks
Maintains system management for labelling activities including GDMS and approved labelling tracking systems
Produces labelling‑related documentation for submission to HAs such as tracked‑change versions, annotated labels, comparison tables, and annotated supporting documentation
Performs QC checks on work produced by colleagues
Identifies incremental improvements to labelling‑related processes and systems for exploration by senior labelling managers
Meets defined productivity, quality, and compliance targets as set by management
Utilizes regulatory labelling expertise to review, develop and deliver labelling documents for submission to Regulatory Authorities across markets/regions, requesting medical input as appropriate
Supports other deliverables within ILG responsibilities (e.g., readability testing)
Contributes to projects involving current and new global tools, technologies, and processes supporting label development, submission, and approval - with a focus on digital solutions
Participates in research incubator initiatives involving automation, machine learning, BPM, etc.

Fulltime

Regulatory Affairs Specialist

An excellent opportunity to join a leading global food business based in central...

Location

United Kingdom , London

Salary:

45000.00 - 50000.00 GBP / Year

The People Co.

Expiration Date

Until further notice

Requirements

5+ years of technical or regulatory experience in food, feed or ingredients
Highly analytical, and organised with keen attention to
Must be able to identify problems and provide systematic
Be able to multi-task and have excellent communication skills
Real team player – Must be able to work with senior and junior employees in a professional and inclusive manner
A high level of business English is essential
The successful candidate will be self-motivated
Strong administration skills on Microsoft Office Packaging on Windows

Job Responsibility

Ensure regulatory compliance with food and feed safety, quality and defence as it relates to UK, EU and GFSI (BRC) requirements, Organic, Halal, FAMI QS and Kosher
Monitor changes in legislation and regulatory requirements, proactively assessing the impact on business and updating the senior management team's compliance protocols as necessary
Support the development and implementation of regulatory strategies for existing ingredients and new ingredients/products in the UK and EU regions ensuring compliance to but not limited to Allergens, REACH, Novel food, Packaging Food Contact Materials, Food Law and labelling, Feed laws and labelling, Residues and Contaminants, Natural and Botanical ingredients etc
Provide regulatory review of product compliance when an in-depth analysis/review is needed for the quality department. Example of review provided: Novel food status, specific application status, claims, labelling
Coordinate with authorities for all work required, such as authorisation and licenses
Support the design and maintenance of Prinova Specification, ensure all information is correct and meets relevant EU regulation requirements
Provide training for the quality and technical teams in Europe
Actively support QA department tasks according to workload and priorities, as required
Provide support to the commercial and marketing team to verify regulatory compliance
Assisting, as required, in the management of crises and incidents as part of the management team

Senior IT Engineer – Research & Development

The Senior IT Engineer – R&D acts as the interface between the R&D business unit...

Location

Italy , Bologna; Milano

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Bachelor's or Master’s Degree in Information Technology, Statistics, Biotechnology or other relevant field
4–6 years of experience in IT in the Life Sciences/Biotech/Pharma sector
Solid understanding of IT R&D processes and/or application management with a proven track record of delivering results across multiple project settings
Strong understanding of the R&D Pharma environment and experience in one or multiple areas such as e.g. Clinical, Pharmacovigilance, Regulatory, Medical Affairs
Knowledge of R&D software such as electronic Trial Master Files, Clinical Data Management solutions, Pharmacovigilance and Regulatory applications
Experience with GxP and GAMP5 frameworks
Proven experience in managing vendor relationships
Familiarity with Agile, Scrum, and/or Waterfall methodologies and ideally Project Management tools (e.g. SmartSheet, Microsoft Project)
Proficiency in Microsoft Office Suite
Strong communication and stakeholder management skills

Job Responsibility

Collect and analyze business requirements from R&D stakeholders
Translate business needs into functional and technical specifications
Collaborate with IT teams (architecture, development, support) to evaluate feasibility and define solution proposals for R&D use cases
Support the management of software implementations and data migration projects for the R&D solutions’ portfolio
Support the prioritization of initiatives based on business value, urgency, and alignment with strategic objectives
Contribute to the evaluation and development/implementation of AI initiatives for R&D use cases
Monitor the demand pipeline and maintain a clear overview of ongoing and planned IT R&D initiatives
Facilitate workshops and meetings between business and IT to ensure shared understanding and alignment
Contribute to building business cases for new IT R&D initiatives
Support change management activities and user adoption of delivered solutions

What we offer

competitive salary
comprehensive benefits
extensive opportunities for professional growth and development

Fulltime

Senior Quality Engineer

Senior Quality Engineer has responsibility for working independently, with cross...

Location

United States , Sparks

Salary:

92700.00 - 152900.00 USD / Year

BD

Expiration Date

Until further notice

Requirements

Bachelor's Degree in Biological Sciences, Chemistry, and/or Regulatory Affairs or other related field with minimum of 5 years’ experience within the quality function or Master’s Degree with minimum of 3 years' experience in quality
Experience handling multiple projects simultaneously in a fast-paced environment
Proficiency with Microsoft Office (Word, Excel, PowerPoint) required
Pharma/Medical device industry experience preferred
Experience with Minitab or other statistical analysis platforms preferred

Job Responsibility

Initiates and/or supports CAPAs and may lead the investigation/corrective action process
Responsible for the various aspects of ID/AST plant sustaining, validation, & NPD Quality Engineering, including routine Quality Engineering responsibilities for assigned ID/AST products and quality system focus
Directly responsible to the Plant Quality Manager for the continued consistent implementation/application of Quality Systems as it relates to the product line
Uses tools for risk analysis/management, 8D, validation, and project management, sampling plans, Six Sigma, control plans, design control and trending
Drives for continuous improvement in all areas and participates on Continuous Improvement teams and recommends improvements, implements changes, and verifies effectiveness of changes
Develops and maintains efficient methods for regularly reporting status to management the product quality with respect to Quality objectives and goals and provides plant quality metrics as required to generate quality system improvements

Fulltime

Senior Director, Political Affairs

AHLA is seeking a full-time Senior Director, Political Affairs. The Senior Direc...

Location

United States , Washington

Salary:

130000.00 - 150000.00 USD / Year

American Hotel & Lodging Association

Expiration Date

Until further notice

Requirements

Bachelor’s degree in political science, Communications, or related area or equivalent work experience
5-10 years of experience in PAC management, political fundraising, campaign finance compliance, and/or related public affairs roles
Extensive knowledge of FEC compliance, federal and state campaign finance laws, and lobbying disclosure requirements
Demonstrated experience in a senior role managing a corporate, association, or other PAC program with national reach
Proven strategic thinker and collaborator with the ability to lead complex projects and drive a large political program
High-level project management, analytics, and organizational skills
Exceptional oral and written communication and presentation skills, including for executive-level audiences
Strong political acumen and understanding of the political campaign ecosystem
Professionalism and discretion in handling sensitive political and legal matters
Ability to work independently in a fast-paced environment, while also being an excellent collaborator

Job Responsibility

Lead and evolve the long-term vision, growth strategy, and operations of HotelPAC to enhance its influence and fundraising capabilities with a goal of reaching $1.5m per year in donor contributions
Serve as the primary architect of all PAC-related strategic plans, solicitation campaigns, donor engagement, and stakeholder communications
Provide strategic counsel to senior AHLA leadership and the PAC Board, including regular analysis, reporting, and recommendations to advance AHLA’s advocacy objectives
Develop high-level presentations and strategic reports for Executive Leadership, Board Members, and the PAC Advisory Council
Ensure full compliance with all FEC, IRS, and state-level regulatory and reporting requirements for PACs, c4 entities, and lobbying disclosures
Oversee the preparation and timely filing of federal and state lobbying and campaign finance reports in coordination with legal and compliance vendors
Serve as the internal subject matter expert on campaign finance law, corporate PAC governance, lobbying compliance, and ethics
Direct external compliance consultants and legal counsel to maintain audit-ready records and mitigate risk exposure
Design and manage year-round PAC marketing, communications, and fundraising strategies targeting member companies and industry leaders
Drive donor cultivation initiatives, including executive-level engagement, peer-to-peer outreach programs, and customized solicitation campaigns

Fulltime

Legal Counsel, Compliance

This role will report to the Director of Financial Crime and Compliance and MLRO...

Location

Hong Kong

Salary:

Not provided

Sotheby's

Expiration Date

Until further notice

Requirements

Qualified lawyer
3 plus years of post-qualification experience in a regulatory or financial crime practice area at a leading commercial law firm in HK, Europe or the US
Comprehensive understanding of applicable anti-money laundering regulations and sanctions regimes
Experience in advising on anti-money laundering regulations and sanctions regimes
Excellent analytical and written skills
Good communication and presenting skills
Ability to assess and balance commercial and regulatory risks
Ability to think strategically
Ability to provide clear guidance and workable, commercial solutions on complex and sensitive issues
Excellent relationship management and people skills

Job Responsibility

Supporting and advising on financial crime compliance in Asia, including AML/CTPF, sanctions and ABC and corporate offences
Supporting the MLRO with managing Sotheby’s internal suspicious activity reporting processes and record-keeping in Asia
Acting as the Nominated Officer for Sotheby’s Singapore
Assisting with developing, maintaining and keeping under review, Sotheby’s business wide risk assessments, policies and procedures in relation to financial crime
Supporting the continuous development, improvement and implementation of Sotheby’s systems controls, policies, procedures and tools to mitigate financial crime risk
Equipping existing core operational functions in Asia with adequate anti-financial crime awareness and compliance
Acting as point of escalation to advise on and assist with the onboarding of new clients and review of existing clients and their transactions in Asia
Perform complex enhanced due diligence reports for higher risk clients, counterparties and transactions
Supporting oversight of regulatory affairs in Asia
Maintaining in-depth knowledge of relevant financial crime and corporate offence regulations, laws and regimes in Asia

Senior Regulatory Affairs Officer

SRG

Location:
United Kingdom , Edinburgh

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 21, 2026

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