Senior Regulatory Affairs Consultant Job at Parexel

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

New

Senior Regulatory Affairs Consultant - Regulatory Labeling Strategist

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

5-7 years in biotech/pharmaceutical industry
2+ years in global labeling/regulatory with global strategic leadership responsibilities
Proven ability to lead cross-functional teams and influence stakeholders across diverse cultural and geographic settings
Strong knowledge of US, EU, DE, CH, AU regulatory labeling lifecycle management
Experience with direct-to-consumer advertising, social media review, and Health Authority negotiations
Must be familiar and able to work with RIMS (e.g., Veeva RIMS), eDMS (e.g., Veeva), Apollo, Docubridge, and Change Management systems (e.g., Trackwise)
Experience with Microsoft Office applications, SharePoint, Adobe Acrobat, TVT, Promomats, and GLAMS
Knowledge of regulatory requirements relevant to drug development, global labeling, and post-marketing (US, EU, AU, DE preferred)
Demonstrated problem-solving ability with risk analysis and sound decision-making
Strong collaboration skills, with experience working in global, cross-cultural, matrix environments

Job Responsibility

Define and drive global labeling strategy across foundational and non-foundational markets (US, EU, AU, CH, DE)
Lead creation, revision, and management of core labeling documents, including Core Data Sheet (CDS), USPI, EU SmPC, Global Patient Leaflet, and Target Label Profile
Align labeling content and strategy across U.S., EU, and global regulatory teams
facilitate timely endorsement of labeling decisions by senior leadership
Interpret clinical and scientific data to inform labeling content and product claims
identify strategic risks and opportunities
Remain current with global labeling regulations and provide training to internal stakeholders
Chair and manage Labeling Review Committee (LRC), Global Labeling Committee (GLC), and CCDS Working Team—set agendas, drive decisions, and ensure timely implementation
Develop and maintain governance frameworks for company positions (DLS, CCDS, USPI, EU SmPC) and foundational markets
Influence external labeling landscape through policy intelligence and strategic engagement

Fulltime

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 Consultant - Regulatory Affairs

LifeBee, is a ProductLife Group Company and leading international strategic and ...

Location

Italy , Firenze; Milano; Rome

Salary:

Not provided

Product Life Group

Expiration Date

Until further notice

Requirements

STEM degree (i.e., computer science, computer engineering, biomedical engineering, statistics, mathematics, physics)
2 or more years’ experience in Consultant role familiarity with Life Science Software solution, regulations and guidelines good knowledge of individual productivity tool (MS Office)
Knowledge of Life Sciences Software solutions, regulations and guidelines
Analytical and problem solving approach
Fluency in Italian and English is required.

Job Responsibility

Advising customers, on the most suitable solutions to their needs
Implementing, customizing, integrating, test and validation of market-leading and cutting-edge software applications for Life Sciences
Planning and executing projects streams, drafting specification, tests and validation technical documentation
Enhancing collaboration with local and global software vendors
Providing qualified technical and functional support and training
Aiding customers in technical validation activities

Fulltime

Senior Regulatory Affairs Consultant - Project Management

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

Location

South Korea , Seoul

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Minimum 7 years of experience in Pharma, Biotech, or CRO required
Regulatory Compliance (GMP) and US NDA/EU MAA experience preferred
ideally native Korean speaker and proficient in English to collaborate with the global team
Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree preferred

Job Responsibility

Project Execution
Consulting Activities and Relationship Management
Business Development
Parexel-related Responsibilities

What we offer

Flexible working arrangements including hybrid work options
opportunities for career growth
supportive and inclusive environment
patient-led culture
global client exposure
learn from experts
Flexible Work Program
Bravo Recognition Program

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

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Senior Regulatory Affairs Consultant

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