Regulatory Affairs Consultant Job at Amaris Consulting (Latina)

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 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

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

Head of Regulatory Affairs Americas

We're making the world of digital assets accessible and secure for everyone. Joi...

Location

United States , Miami, Florida

Salary:

Not provided

Ledger

Expiration Date

Until further notice

Requirements

Minimum 8 years experience at a financial regulatory agency or policymaking body, or covering regulatory topics in the legal, fintech, or financial services sectors
Prior crypto industry experience a plus
Knowledgeable about blockchain technology and the US and Latin America crypto-asset regulatory landscape
Knowledgeable about US and Latin American financial regulations, such as those applicable to crypto-asset service providers, payment services providers, E-money institutions, banks and custodians, securities and financial instrument issuers, and trading platforms
Specific knowledge of AML/CFT and financial sanctions law and international standards is desirable
Ability to quickly learn and adapt to new regulatory subject matters and jurisdictions
Proven relationships with key stakeholders, such as those at regulatory agencies and international bodies, legislatures, and central banks
Fluency in English required
fluency in Spanish is strongly desired
Exceptional communication skills, both written and verbal

Job Responsibility

Build and maintain subject matter expertise of the changing regulatory landscape in the areas of digital assets, financial services and capital markets
Advise business units and senior leadership on the development and adaptation of products, business lines and business models in light of existing or anticipated regulatory requirements
Define and execute strategies to proactively influence the development of favorable digital asset regulation in North and South America
Coordinate with the Global Head of Policy on identifying and reacting to significant public policy challenges and opportunities with respect to Ledger’s business priorities
Build strong relationships with other regulatory professionals in the digital asset and traditional finance ecosystems, as well as with relevant governmental authorities and multinational bodies
Lead the development of Ledger’s responses to regulatory proposals, solicitations and consultations
Lead the response of Ledger to regulatory inquiries, examinations or investigations, and contribute to crisis response teams as assigned
Represent Ledger’s perspective on regulatory policy through public speaking and written thought leadership
Assist the Global Head of Policy in managing outside consultants and membership organisations

What we offer

Training: Get trained and gain experience in one of today's most exciting and growing industries
Equity: Employees are the foundation of our success, and we award stock options so you can share in that success as we grow
Medical: Comprehensive health insurance policy offering extensive medical, dental and vision care coverage
Well-being: Personal development, coaching & fitness with our dedicated partners
Vacation: 20 days of paid leave per year
Retirement: 401k with employer match
High tech: Access to high performance office equipment and gadgets, including Apple products
Transport: Ledger reimburses part of your preferred means of transportation
Discounts: Employee discount on all our products

Fulltime

Head of Regulatory Affairs Americas

As Head of Regulatory Affairs for the Americas, you will report to the Global He...

Location

United States , Washington, District of Columbia

Salary:

Not provided

Ledger

Expiration Date

Until further notice

Requirements

Minimum 8 years experience at a financial regulatory agency or policymaking body, or covering regulatory topics in the legal, fintech, or financial services sectors. Prior crypto industry experience a plus
Knowledgeable about blockchain technology and the US and Latin America crypto-asset regulatory landscape
Knowledgeable about US and Latin American financial regulations, such as those applicable to crypto-asset service providers, payment services providers, E-money institutions, banks and custodians, securities and financial instrument issuers, and trading platforms
Specific knowledge of AML/CFT and financial sanctions law and international standards is desirable
Ability to quickly learn and adapt to new regulatory subject matters and jurisdictions
Proven relationships with key stakeholders, such as those at regulatory agencies and international bodies, legislatures, and central banks
Fluency in English required
fluency in Spanish is strongly desired
Exceptional communication skills, both written and verbal
comfort with public speaking

Job Responsibility

Build and maintain subject matter expertise of the changing regulatory landscape in the areas of digital assets, financial services and capital markets
Advise business units and senior leadership on the development and adaptation of products, business lines and business models in light of existing or anticipated regulatory requirements
Define and execute strategies to proactively influence the development of favorable digital asset regulation in North and South America
Coordinate with the Global Head of Policy on identifying and reacting to significant public policy challenges and opportunities with respect to Ledger’s business priorities
Build strong relationships with other regulatory professionals in the digital asset and traditional finance ecosystems, as well as with relevant governmental authorities and multinational bodies
Lead the development of Ledger’s responses to regulatory proposals, solicitations and consultations
Lead the response of Ledger to regulatory inquiries, examinations or investigations, and contribute to crisis response teams as assigned
Represent Ledger’s perspective on regulatory policy through public speaking and written thought leadership
Assist the Global Head of Policy in managing outside consultants and membership organisations

What we offer

Training: Get trained and gain experience in one of today's most exciting and growing industries
Equity: Employees are the foundation of our success, and we award stock options so you can share in that success as we grow
Medical: Comprehensive health insurance policy offering extensive medical, dental and vision care coverage
Well-being: Personal development, coaching & fitness with our dedicated partners
Vacation: 20 days of paid leave per year
Retirement: 401k with employer match
High tech: Access to high performance office equipment and gadgets, including Apple products
Transport: Ledger reimburses part of your preferred means of transportation
Discounts: Employee discount on all our products

Fulltime

Director, Regulatory Labeling

Beam is seeking a Director of Regulatory Affairs – Advertising, Labeling, and Pr...

Location

United States , Cambridge

Salary:

210000.00 - 260000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

BS required
an advanced degree (i.e. MS, PharmD, PhD, MD) is a plus
A minimum of 6 years of experience working in Regulatory Affairs Advertising, Labeling, and Promotion
ideally 15 plus years in the biotech industry with at least 8 years in regulatory affairs
Record of success with interactions with Regulatory Agencies and Health Authorities as part of label negotiations and label updates
Comprehensive knowledge of US and global regulatory procedures and practices
Extensive experience with regulatory documents and filings (IND, CTA/IMPD, BLA, MAA, PIP)
Strong strategic thinking and problem-solving skills
Experience in representing programs to internal and external stakeholders
Ability to develop collaborative working relationships internally as well as externally with physicians, expert consultants, and contracted vendors

Job Responsibility

Lead the creation, review, and approval of critical regulatory labeling documents including Core Data Sheet and Regional Labels for Beam hematology programs in alignment with Target Product Profiles
Lead labeling negotiations between Beam and health authorities as part of marketing authorization applications
Create regulatory labeling processes and associated SOPs, Work Instructions, and any other required documentation
Represent Regulatory Affairs as part of the Promotional Review Process
Incorporate the evolving global regulatory requirements and guidance's with respect to gene editing and gene therapy, rare disease, and prescription drug labeling
Provide innovative regulatory approaches, solutions and guidance to cross-functional teams while mitigating regulatory risks
Guide and assist on the planning, preparation, writing and submission of regulatory documentation
Manage project plans and timelines to ensure all projects are prioritized appropriately and milestones and goals are met on time
Provide regulatory due diligence as required
Supervise and mentor direct reports

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

Senior Director, Regulatory Affairs

Senior Director role in Regulatory Affairs at Beam Therapeutics, a biotechnology...

Location

United States , Cambridge

Salary:

260000.00 - 320000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor’s Degree or foreign equivalent, in regulatory affairs
or a closely related field
Five (5) years of progressive, post-baccalaureate experience including: Working in regulatory affairs
Developing regulatory documents and submissions
and Presenting corporate development programs to regulatory agencies
The required five years must also include at least one year of experience (which may have been gained concurrently) involving: Regulatory affairs work within biotechnology specifically, including application of U.S. and global regulatory procedures and practices
Developing regulatory documents and submissions such as IND, CTA/IMPD, BLA, MAA and PIP
and Managing projects in biotechnology regulatory affairs

Job Responsibility

Supporting development and implementation of global regulatory strategy for innovative genetic medicine programs within a fast-paced biotechnology environment
Ensuring integration of regulatory tactics with broader corporate strategy across non-clinical, clinical and commercial development stages
Incorporating evolving United States and global regulatory requirements related to gene editing, gene therapy, rare disease, orphan indications, breakthrough therapies and expedited regulatory pathways
Representing the Regulatory Affairs function on cross-functional and project teams to provide regulatory input throughout development
Developing innovative regulatory approaches, solutions and guidance while mitigating regulatory risks
Collaborating with external stakeholders, including experts, consultants and contracted vendors
Guiding planning, preparation, construction and submission of regulatory documentation
Managing project plans, timelines and prioritization to ensure milestones and goals are achieved
Providing regulatory due diligence support

Fulltime

Regulatory Affairs Consultant

Amaris Consulting

Location:
Italy , Latina

Category:
-

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
March 21, 2026

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