Regulatory Affairs Officer Job at SRG (Edinburgh)

Regulatory Affairs Officer

As a Regulatory Affairs Officer, you will be responsible for developing regulato...

Location

United Kingdom , Edinburgh

Salary:

Not provided

SRG

Expiration Date

Until further notice

Requirements

A relevant degree or equivalent experience in regulatory affairs
Previous experience in regulatory submissions and compliance within medical devices or related industries
Strong knowledge of CE and FDA regulations, including PMA, BLA, and 510(k) submissions
Excellent technical writing skills and proficiency in MS Office
Ability to work independently and collaboratively in a fast-paced environment
Exceptional attention to detail, time management, and problem-solving skills

Job Responsibility

Prepare and compile regulatory documentation and coordinate submissions for global markets, including US, EU, Canada, and others
Advise internal teams on data requirements for successful license applications
Develop and maintain product labelling requirements and liaise with stakeholders
Monitor regulatory changes and maintain compliance with ISO13485, IVD Directive 98/79/EC, IVD Regulation 2017/746, FDA CFRs, and other global standards
Maintain technical files and regulatory documents for multiple territories
Communicate effectively with regulatory authorities and external bodies
Support process improvements and provide guidance and training to team members

Fulltime

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

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

Intern, regulatory information management and technology

The BioMarin Summer Internship Program will enable students to gain valuable exp...

Location

United States

Salary:

24.00 - 27.00 USD / Hour

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

Knowledge of the Regulatory Affairs submission process
Proficient computer skills and working knowledge of Microsoft Office (Word, Excel, PowerPoint and Outlook)
Excellent interpersonal, written and verbal communication skills
Strong organizational skills with ability to prioritize and manage tasks in a fast-paced environment
Ability to work independently and collaboratively
Student pursuing a Bachelor’s degree in computerized systems or life sciences (or in related fields of study)
Student must be returning to school in the Fall Term OR has graduated within the 1 year of the start of the program
Must be available to work 40 hours a week
Must be authorized to work in the United States without visa sponsorship

Job Responsibility

Provide Regulatory Data Management and Regulatory Systems Usage/Implementation assistance for Global Regulatory Affairs RIMT group
Utilizing Information Management skills, provide Business Analysis to assist in enhancing existing Regulatory Information management data quality
Assess and reconcile regulatory details associated with Regulatory Health Authority Applications to support both Marketing and Investigational Drug Product authorizations
Providing support for Operational Change Management activities relating to technology improvements related to the Veeva RIM platform

What we offer

Paid hourly wage
Paid company holidays
Sick time
Apply skills and knowledge learned in the classroom to on-the-job experiences
Comprehensive, value-added project(s)
Develop skills specific to your major
Opportunities for professional development by building relationships and learning about other parts of the business
Participate in company all hands meetings, monthly community lunches
Corporate office amenities such as: 24/7 on-site gym, coffee truck, snacks
Access to Employee Resource Groups

Fulltime

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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