Regulatory Affairs Officer Jobs

EU Affairs Officer

EU Affairs Officer position at METLEN Energy & Metals, responsible for monitorin...

Location

Belgium , Brussels

Salary:

Not provided

Metlen Group

Expiration Date

Until further notice

Requirements

Bachelor's Degree in Law, Finance, Engineering, Political Science or European Studies
Postgraduate Degree
Thorough understanding of the EU's institutions and legislative process
Knowledge of regulatory issues, especially in the fields of energy (electricity and gas), climate, competition and/or defence
1-3 years' experience in a similar position
Excellent knowledge of the English language
Ability to work with tight deadlines according to the organizational needs
High professionalism and great attention to detail are essential
Excellent communication and interpersonal skills
Strong research and analytical skills

Job Responsibility

Actively monitors EU policy and regulatory developments in areas of relevance to METLEN (energy, climate, industrial policy, competition, taxation, environmental matters, trade, funding, defence etc.)
Advises the European Affairs & Regulatory Advocacy Division on all matters relating to EU regulation
Supports the European Affairs & Regulatory Advocacy Division in public affairs activities in Brussels, including drafting contributions to public consultations, attending debates, workshops and conferences, and interacting with EU policymakers and other relevant stakeholders
Actively contributes to activities organized by trade associations in which METLEN is a member, including attending meetings and contributing to the drafting of position papers
Prepares policy briefs, email updates and presentations related to the latest EU policy developments

Fulltime

Pharmacovigilance and regulatory affairs manager BeNeLux

Responsible for overseeing Regulatory affairs and Pharmacovigilance activities a...

Location

Netherlands , Utrecht

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Minimum 5-10 years of experience in regulatory affairs and pharmacovigilance within pharmaceutical company
Knowledge of local pharmaceutical legislation for Regulatory in the BeNeLux region
Knowledge of applicable laws and regulations to ensure full compliance
Knowledge of Regulatory affairs and Pharmacovigilance activities (act as primary contact for regulatory authorities and for external consultants in the regions, ensuring compliance of Product Information, API, approval of artworks for packaging materials and implementation of aRMM)
Proficiency in speaking, comprehending, reading and writing Dutch is required
Proficiency in speaking, comprehending, reading and writing English is required
Ability to think strategically & execute tactically

Job Responsibility

Act as local single point of contact for global functions in Regulatory Affairs and Pharmacovigilance for the BeNeLux
Act as the Local Safety Officer (LSO) for the Netherlands, Belgium and Luxembourg
Act as primary contact for regulatory authorities and for external consultants, ensuring compliance of Product Information, approval of artworks for packaging materials and implementation of aRMM
Responsible for creating and keep the local Regulatory affairs and Pharmacovigilance SOPs up to date
Responsible for training of BeNeLux team in local Regulatory affairs and Pharmacovigilance SOPs
Work closely together with Pharmacovigilance and regulatory affairs managers within the BNS cluster (BeNeLux Nordics and Switzerland) creating a network of knowledge and international cooperation and support
Collaborate with commercial, medical and market access to realize cross-functional objectives

What we offer

Competitive salary and benefits package
Opportunities for professional growth and development

Non-Pharma Global Regulatory Affairs Manager

The Global Regulatory Sciences-Legacy Products-Non-Pharma Manager manages regula...

Location

Italy , Bologna; Milano; Pomezia

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Proven experience in Regulatory Affairs within the pharmaceutical or life sciences industry, preferably within the food supplements, medical devices, and cosmetics sectors
Hands-on experience with regulatory submission processes, especially within EU and/or RoW markets or similar relevant experiences
Demonstrated ability to coordinate projects or deliverables with complexity and limited supervision
Advanced degree in Life Sciences, Pharmacy, Chemistry, or a related field
Good knowledge of global regulatory frameworks including EU regulations for medical devices (MDR, MDD) and relevant legislation for food supplements and cosmetics
Strong organizational skills, attention to detail, and ability to manage priorities
Collaborative mindset and effective communication with team members and stakeholders
Ability to operate independently on clearly defined assignments
Proficiency in Microsoft Office Suite and regulatory submission/document management tools
Fluent in English, both written and spoken

Job Responsibility

Accountable for providing the necessary regulatory inputs in a cross-functional team for the development of new projects
Accountable for the execution and implementation of global regulatory strategies by managing day-to-day activities for assigned products
Manage multiple regulatory workstreams independently, including authoring, reviewing and coordinating documentation for regulatory submissions such as variations, renewals and geo-expansions
Provide and review regulatory assessments for change controls and product updates
Responsible for the preparation, review and collection of documentation for submission and maintenance of Technical File and PTD for the project assigned
Provide critical review of documentation supporting regulatory applications
Coordinate with local affiliates and global stakeholders to ensure submissions are aligned with timelines and business priorities
Contribute to the preparation and presentation of regulatory project updates in internal meetings and governance committees
Execute defined regulatory tasks within scope and deadlines under the guidance of the Head
Support other relevant assignments as directed by supervisor

What we offer

Competitive salary
Comprehensive benefits
Extensive opportunities for professional growth and development

Non-Pharma Global Regulatory Affairs Specialist

The Global Regulatory Non-Pharma Specialist manages regulatory documentation and...

Location

Italy , Bologna

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

At least 5 years’ experience in Regulatory Affairs preferably within the food supplements, medical devices, and cosmetics sectors
Exposure to regulatory operations or documentation in EU and/or RoW markets or similar experiences is preferred
Advance degree in Life Sciences, Pharmacy, Chemistry, or a related field
Relevant certifications in Regulatory Affairs are considered a plus
Good knowledge of EU regulations for medical devices (MDR, MDD) and relevant legislation for food supplements and cosmetics
Strong attention to detail, time management and organizational skills
Willingness to learn and ability to work effectively in a team-based environment
Strong communication and interpersonal skills
Proficiency in Microsoft Office Suite and familiarity with document management systems
Fluent in English, both written and spoken

Job Responsibility

Contributing in a cross-functional team to provide the necessary regulatory input for the development of new projects
Support regulatory strategies by providing impact assessments
Collaborate actively with the Research & Development team to integrate regulatory requirements during the design and development of assigned products
Prepare, organize and submit regulatory documentation for submission and maintenance of dossiers for the projects assigned
Coordinate with local affiliates and global stakeholders to ensure submissions are aligned with timelines and business priorities
Manage multiple tasks in a fast-paced environment while keeping on task and to the company’s quality standards
Contribute to the preparation of regulatory project updates in internal meeting and governance committee providing regulatory input and flagging risks
Assist colleagues with administrative tasks
Execute defined regulatory tasks within scope and deadlines under the guidance of the Head
Review and validate commercial artwork, packaging, and labeling in compliance with EU Regulations, ensuring timely product launches

What we offer

Competitive salary
Comprehensive benefits
Extensive opportunities for professional growth and development

Cmc officer

Are you looking to grow professionally and make the most of your knowledge and s...

Location

Greece , Athens

Salary:

Not provided

Randstad

Expiration Date

December 30, 2025

Requirements

Minimum 2 years of experience in a R&D or CMC position
Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Studies or related sciences
Knowledge of the scientific (chemistry, manufacturing, control) documentation and registration requirements of the generic pharmaceutical products CTD dossier
Superb communication skills
Excellent knowledge and handling of both verbal and written English language

Job Responsibility

Compiling pharmaceutical CTD dossiers in eCTD format, followup until MAs are granted, and life-cycle maintenance of the world-wide registration of pharmaceutical products in regard to chemistry, manufacturing, control related documentation
Assist in the collection and evaluation of data to be included in module 3 of marketing authorization dossiers
Respond to queries (from regulatory authorities or clients) concerning dossiers, manage the process to respond to the CMC questions by involving all stakeholders both within and outside the company and following up agreed actions to respond as rapidly and completely as possible
Assist in keeping the dossier core files (Module 3 and corresponding QoS) fully up to date during registration procedures and because of variations
Participate in meetings related to registration procedures or when the CMC expertise is needed. Tightly collaborate with the RA and R&D Departments for assigned products
Prepare the variation and post-approval change packages and other necessary documents as required by the variation process
Ensure that all documents and records pertaining to the CMC Department are archived properly. Keep departmental database or other tracking system up to date
Review regulatory compliance protocols and/or reports, as requested
Participate in the change control system and variation process according to the established workflow and contributing to renewal applications

!

Federal Affairs Lead

Archer Aviation is hiring a Federal Affairs Lead to strengthen our efforts in sh...

Location

United States , Washington

Salary:

115000.00 - 154000.00 USD / Year

Archer Aviation

Expiration Date

Until further notice

Requirements

At least 3 years of relevant policy, regulatory, or government affairs experience
Bachelor’s degree in public policy, political science, or related field (Hill experience is preferred)
Familiarity with federal transportation, aerospace, or emerging technology policy
Strong written and verbal communication
being able to explain technical concepts to non-technical audiences
Proven ability to build and maintain relationships with government official’s staff, stakeholders and advocacy organizations
Skilled at analyzing policy documents and making clear, actionable recommendations

Job Responsibility

Support Archer’s federal government affairs strategy to advance policies that enable the growth of the AAM industry
Build and maintain strong relationships with key Congressional offices, federal agencies, and industry associations to advocate for Archer’s priorities
Monitor and analyze policy and regulatory developments
provide timely insights and recommendations to internal teams
Represent Archer at relevant D.C. events, conferences, and member organization meetings, ensuring the company’s voice is influential in shaping the future of AAM
Develop clear and compelling presentations, briefings, and advocacy materials for policymakers and regulators
Collaborate with internal teams to align policy strategy with business objectives and foster a results driven environment

Regulatory Coordinator

We are seeking a meticulous and organized Regulatory Coordinator to ensure that ...

Location

Sweden , Stockholm

Salary:

Not provided

EnglishJobs.se

Expiration Date

Until further notice

Requirements

Proven experience in regulatory affairs, clinical research, or a similar compliance-focused role
Solid understanding of GCP, ICH guidelines, and regulatory requirements for clinical trials
Strong organizational skills with the ability to manage multiple projects and deadlines
Excellent attention to detail and accuracy in documentation
Proficiency in Microsoft Office Suite and familiarity with document management systems
Strong communication and collaboration skills
Fluency in English
Swedish language skills are an advantage

Job Responsibility

Support the preparation, review, and submission of regulatory documents to authorities and ethics committees
Ensure all trial documentation is accurate, complete, and maintained in compliance with Good Clinical Practice (GCP), regulatory requirements, and company policies
Coordinate the collection, organization, and archiving of essential trial documents
Track regulatory submission timelines and ensure deadlines are met
Assist in preparing trial master files and ensuring ongoing inspection readiness
Collaborate with clinical operations, quality assurance, and legal teams to resolve compliance issues
Maintain up-to-date knowledge of relevant regulations, guidelines, and industry standards
Participate in audits and inspections, providing requested documentation and information
Monitor changes in regulatory requirements and communicate updates to relevant stakeholders
Provide administrative and logistical support for regulatory meetings and communications

What we offer

A collaborative and quality-focused work environment
Opportunities for professional growth and training in regulatory affairs
Competitive salary and benefits package
The chance to contribute to clinical research projects with global impact

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 Officer

SRG

Location:
United Kingdom , Edinburgh

Category:
Health and Beauty

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
December 25, 2025

Looking for more opportunities? Search for other job offers that match your skills and interests.

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SRG

Location:United Kingdom , Edinburgh

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Job Description:

Job Responsibility:

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