Senior Consultant - Regulatory Affairs Job at Product Life Group (Firenze)

Senior Regulatory Affairs Consultant - Regulatory Intelligence

As part of Parexel Consulting, you will play a vital role in helping biopharmace...

Location

United States , Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

At least 5-7 years of regulatory affairs experience to include previous regulatory intelligence experience
Knowledge of FDA regulations as well as an understanding of the Summary basis of approval and labeling is helpful
A minimum of a bachelor’s degree in a scientific or technical discipline, advanced degree preferred
Project management / leadership experience
Excellent interpersonal and intercultural communication skills, both written and verbal
Client-focused approach to work (Quality)
Results orientation
Teamwork and collaboration skills
Consulting skills
Critical thinking and problem-solving skills

Job Responsibility

Regularly search the public domain for new and updated regulations and regulatory guidance documents that can impact the client’s development programs, and report the most critical findings
Regularly search the public domain for competitor product regulatory developments and report the most critical findings
Inform client immediately of any changes to the regulatory environment directly affecting client’s business
Search for non-compliance letters or notices for client’s suppliers and provide a regular report
Perform ad hoc research on specific regulatory topics at client’s request, using the internet and various subscription database tools
Identify public commenting opportunities for draft guidances/regulations and coordinate review and comments from client. Lead the client’s internal process to obtain and coordinate SME impact assessments/comments, facilitate comment collection/assimilation, and help develop company messaging to share either with PhRMA working groups or directly with Health Authorities.
Maintain a list of upcoming regulatory meetings/workshops/conferences pertinent to client
Support Regulatory Intelligence activities, including the use of Cortellis, Citeline, WebWatcher. This includes tracking, coordinating and participating in ad hoc searches as well as scheduled activities.

What we offer

Flexible work arrangements
Opportunities for career growth
Supportive and inclusive environment
Diverse and global client exposure
Learn from experts

Senior Regulatory Affairs Consultant

As part of Parexel Consulting, you will play a vital role in helping biopharmace...

Location

Malaysia

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Fluent in local language, English, oral and written
Expert MS Office skills
Excellent organizational, time management and interpersonal skills in a global environment
Ability to work successfully in a complex global matrix organization
Proven ability to work effectively both independently and in a team
The expertise, determination and courage to resolve or escalate issues as appropriate
Subject matter expert in job area typically obtained through advanced education and work experience
Ideally 5+ years of experience in Regulatory Affairs, oversight, governance or compliance roles within pharmaceutical, biotechnology or healthcare industry
Partner management experience: proven experience in managing relationships with third-party vendors
Ability to work in a highly matrixed organization and to establish successful cross-functional working relationships with people in a wide variety of disciplines and backgrounds, be interpersonally aware and culturally sensitive

Job Responsibility

Ensure oversight on key processes and ensure framework is in place to manage third-party activities E2E ensuring compliance with regulations and company standards
monitor partner performance against agreed-upon metrics and standards, addressing any deviations or deficiencies promptly
Conduct periodic assessments of partners to ensure compliance with local requirements and quality standards, implementing corrective actions as necessary
develop risk mitigation strategies and implement controls to minimize risks associated with partner activities
Act as point of contact for escalations and issue resolution related to partner activities
Stay updated on local regulatory requirements, guidelines, and industry trends to ensure compliance with evolving regulations and communicate to GRA and local team
participating in policy activities with industry groups and trade associations
Support regional regulatory TA teams within GRA, for efficient planning and submission preparation according to local requirements and business needs
Keep internal data bases up to date with local activity and ensure compliance KPIs are adequately kept on track
Act as primary interface with local partners representing the company's regulatory interests and fostering positive relationships and ensure that partner, who is acting on CSL behalf, has the appropriate interactions with HAs

What we offer

Flexible work arrangements

Fulltime

Senior Regulatory Affairs Consultant

ProductLife Group (PLG) is a global life sciences consulting and outsourcing par...

Location

United States

Salary:

170000.00 - 210000.00 USD / Year

Product Life Group

Expiration Date

Until further notice

Requirements

Bachelor’s degree (BA/BS) in a relevant scientific discipline
10–15 years of Regulatory Affairs experience, with strong U.S. FDA exposure
Proven experience in independent development and execution of U.S. FDA regulatory strategies
Proven experience in authoring and leading INDs, NDAs, BLAs, amendments, and HA meeting packages
Proven experience in direct Health Authority interactions as Sponsor Representative
Strong working knowledge of FDA regulations and guidance
Strong working knowledge of ICH guidelines
Strong working knowledge of global regulatory frameworks
Demonstrated cross-functional regulatory leadership
Experience across multiple development stages (early development through registration)

Job Responsibility

Provide regulatory strategic and tactical leadership for biotech and pharma programs across development stages
Serve as Regulatory Lead / Advisor and project or program leader for multiple client engagements
Lead cross-functional teams (Clinical, CMC, Nonclinical) across multiple indications and product types
Develop and drive regulatory strategies, integrated development plans, and key regulatory documents
Coordinate, author, review, and manage Health Authority meeting packages
Coordinate, author, review, and manage special designation requests
Coordinate, author, review, and manage regulatory submissions (INDs, NDAs, BLAs, amendments)
Lead and represent clients in formal FDA interactions, including acting as Authorized Sponsor Representative
Lead and represent clients in formal FDA interactions, including preparing and coaching clients for Health Authority meetings
Interpret and apply FDA regulations, ICH guidelines, and global regulatory frameworks

Fulltime

Senior Regulatory Affairs Consultant - Labelling

As part of Parexel Consulting, you will play a vital role in helping biopharmace...

Location

United Kingdom , Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

University degree in a life science discipline
Strong knowledge of EU regulatory requirements for product labelling and promotional materials
Experience with electronic content management systems and regulatory SOPs
Excellent project management and organizational abilities
Outstanding written and verbal communication skills
Proven ability to work effectively in cross-functional teams
Fluent in English, written and spoken

Job Responsibility

Create, update and maintain EU Product Information in line with CCDS, Agency RTQ, and current labelling requirements
Serve as the key point of contact for EU Product Information for both internal and external stakeholders
Lead reviews, round tables, and approvals for EU Product Information in appropriate systems according to SOPs
Deliver competitive labelling searches and contribute to TLP for early development assets
Ensure timely tracking and management of all EU Product Information in appropriate systems
Lead Readability Testing processes including vendor selection, agreement management, questionnaire review, and submission of final reports
Coordinate Linguistic Review processes with LR Coordinator according to SOPs
Communicate proactively with the Artworks team for artwork and mock-up changes, participating in Change Control Processes
Lead the Local Labelling Committee for creation, review and approval of EU Product Information
Serve on the EU Clearance Committee as primary regulatory reviewer for promotional materials

What we offer

Flexible work arrangements
Opportunities for career growth
Supportive and inclusive environment
Diverse and global client exposure
Learn from experts

Senior Regulatory Consultant - Regulatory Project/Program Manager

As part of Parexel Consulting, you will play a vital role in helping biopharmace...

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

BA/BS degree in a scientific, engineering, or healthcare discipline required
advanced degree (MS, PharmD, PhD) and/or PMP certification strongly preferred
Minimum of 7 years of progressive experience in the pharmaceutical, biotechnology, or related life sciences industry, with at least 5 years in regulatory or regulatory program management
Proven ability to partner on regulatory strategy and lead execution across all stages of product development, including IND/BLA/MAA submissions, global registration, and post-marketing activities
Deep understanding of U.S. regulatory requirements with working knowledge of international (ex-U.S.) regulations and agency expectations
Demonstrated success managing complex regulatory deliverables across cross-functional teams within a matrixed organization, while maintaining alignment to strategic priorities
Hands-on experience with eCTD and a strong command of regulatory documentation, formatting, and submission strategy
Exceptional communication and influencing skills, with the ability to synthesize complex regulatory information and translate it into clear recommendations for senior leadership and global stakeholders
Strong judgment and agility in managing competing priorities, resource constraints, and evolving program needs with flexibility and strategic foresight
Demonstrated ability to leverage project management tools and best practices to enhance visibility, efficiency, cross-functional alignment, and meeting effectiveness across GRSTs and project teams

Job Responsibility

Partner strategically with Global Regulatory Leads to shape and execute forward-looking, globally aligned regulatory plans across all stages of development and post-marketing
Translate regulatory strategy into integrated, actionable plans with clear milestones, critical paths, risks, and opportunities to support effective planning and decision-making
Lead the execution of regulatory plans, ensuring alignment between day-to-day operations and broader strategic objectives across global programs
Identify and propose innovative regulatory pathways and planning scenarios that align with global regulatory expectations and business objectives
Collaborate closely with cross-functional teams and senior leadership to drive clarity, alignment, and accountability for regulatory deliverables, timelines, and interdependencies
Facilitate Global Regulatory Subteam (GRST) meetings and other routine and ad hoc project review forums, ensuring meetings are purpose-driven, well-structured, and focused on decision-making, risk mitigation, and regulatory execution
Apply project management best practices for meeting management and hygiene, including developing and distributing agendas in advance, defining objectives and discussion topics, maintaining action logs, documenting key decisions and next steps, tracking follow-up items to closure, and ensuring materials are stored and communicated appropriately
Partner with Global Regulatory Leads and cross-functional stakeholders to maintain effective GRST governance, meeting cadence, stakeholder alignment, and communication flow across global and regional teams
Anticipate and troubleshoot complex regulatory project and operational challenges, implementing scalable solutions that strengthen team effectiveness, process efficiency, and submission readiness
Prepare and deliver strategic dashboards, reports, and scenario plans to senior stakeholders, translating regulatory progress and risks into actionable business insights

What we offer

Flexibility of working remotely
Supportive and dynamic team
Challenging assignments
Mentorship from experienced regulatory professionals
Opportunities for career growth
Diverse and global client exposure
Learn from experts
Flexible work arrangements

Fulltime

Senior Regulatory Affairs Associate

As part of Parexel Consulting, you will play a vital role in helping biopharmace...

Location

Peru

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Minimum 5+ years of professional experience in clinical trial regulatory affairs
Proven experience preparing and submitting clinical trial dossiers to the Ministry of Health (MOH) in Peru, including review of Annex 05 and completion of Annex 33
Demonstrated experience preparing and submitting clinical trial dossiers in other LATAM countries
Proficiency with Veeva Vault or similar document management system
Advanced written and spoken English proficiency
Strong regulatory strategy expertise in Peru and LATAM countries
Excellent verbal communication skills for presenting complex regulatory strategies to international clients
Client-focused approach with ability to understand and anticipate sponsor needs
Strong critical thinking and problem-solving abilities
Exceptional interpersonal and intercultural communication skills

Job Responsibility

Act as Local Regulatory Contact (LRC) and prepare and submit clinical trials through the REPEC Platform in Peru
Allocate 50% of daily time as Global Regulatory Lead for assigned global projects, providing strategic oversight and coordination
Prepare country-specific labels and review LATAM labels for regulatory compliance and consistency
Deliver verbal and written regulatory strategy communications to global sponsors, tailoring recommendations to country-specific requirements
Maintain and update the Trial Master File (TMF) in Veeva Vault with study documents and critical milestone dates
Keep project management tools current, including budget tracking and quality issue (QI) tools

Fulltime

Senior Regulatory Affairs Specialist

Are you interested in the future of digital health and medical device innovation...

Location

Denmark , Copenhagen

Salary:

Not provided

3Shape

Expiration Date

Until further notice

Requirements

Master’s degree within natural sciences, computer science, engineering or similar
5-10+ years in regulatory affairs (preferably both software and hardware medical devices)
Global regulatory market experience (e.g. EU, UK, Switzerland and MDSAP)
Demonstrated experience applying and interpreting relevant guidance and standards across software and hardware medical devices, including: IEC 60601 series, ISO 14971, IEC 62304, IEC 82304
Strong knowledge of cybersecurity and the evolving regulations for digital health and AI/ML devices
Adaptable and open to change and adjustments in agile work environments
Global mindset and experience with work relations in different cultures

Job Responsibility

Ensuring that regulatory requirements are in place for our innovative medical device software solutions and intraoral scanner portfolio incl. AI devices
Involved in development projects from the start, where your regulatory expertise will be needed as crucial input for the development and market release planning and registration of our devices
Ensuring global device registrations
Working closely with many stakeholders across R&D, Marketing, Product Management and sales offices around the globe as well as local external advisors and regulatory consultants
Active within advocacy and are involved externally in industry organizations and relevant forums influencing policy work and regulatory frameworks

What we offer

An attractive healthcare package to keep you fit and well
Breakfast every day, and a delicious and healthy lunch cooked by our private chefs
Good work/life balance e.g., work from home policy for up to 2 days per week
Amazing location – our office is located in the heart of Copenhagen, right next to Kongens Nytorv
Social clubs, monthly Friday social activities, as well as various in-team activities

Fulltime

Senior Regulatory Affairs and Quality Assurance Professional

In this role, you'll dive into a dynamic industry that actively collaborates acr...

Location

Denmark , København

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

You are driven by the same purpose as us and want to contribute to improving the lives of patients around the world
You have a positive and curious mindset
You understand how to balance quality and pragmatism to ensure the best possible outcome for a given project
You are looking for a fun, friendly, and tolerant working environment in a purpose-driven company where your opinion matters
You have +5 years of experience working with quality assurance in the life science industry
You are interested in learning and have some knowledge within regulatory affairs
You pose a strong understanding and experience with design control, qualification and classification of medical devices, technical documentation and supporting project members in the principles of quality assurance
Strong knowledge or working experience with standards and regulations such as ISO 13485, ISO 9001, IEC 62304, GxP and/or CSV
Strong knowledge or working experience with quality principles such as testing, bug management, and risk-based approach in quality
You have a relevant educational background, e.g. biomedical engineering, software engineering or other relevant areas of science or engineering

Job Responsibility

Drive the regulatory strategy for digital health projects to enable global market launch
Support the development team in quality deliverables and activities according to our internal procedures based on IEC 62304 and ISO 27001
Ensure the quality of health software by adherence to the quality management system
Support and review safety risk management & cybersecurity deliverables
Provide regulatory and quality consultancy within development projects
Communicate with pharma-clients to align on issue resolution and deliverables
Participate in client audits
Using and shaping how to use AI tools in daily work

What we offer

A portfolio of meaningful products that impact patient lives at scale
Autonomy, trust, and support to do the best work of your career
An open, collaborative environment with talented peers across engineering, design, clinical, and regulatory
Career growth in one of the leading digital health scale-ups, alongside world-class pharma partners
The opportunity to leave your mark on the future of digital health
Copenhagen’s best view and best office espresso machine

Fulltime

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Senior Consultant - Regulatory Affairs

Job Description

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