CrawlJobs Logo
Parexel Logo Parexel · Research and Development

Senior Regulatory Affairs Associate

· Job Posted February 18, 2026
Apply Position
Job Link Share

Job Description

As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.

Job Responsibility

  • Lead Local Regulatory Responsible (LRR) oversees LRRs to ensure effective decision making and smooth operations and acts as the first escalation point for LRR challenges
  • Local Regulatory Responsible focuses on local regulatory requirements and Health Authority national engagements.

Requirements

  • 5+ years of (local) regulatory knowledge and experience in a regulatory authority facing role
  • comprehensive understanding of regional and global regulatory requirements, guidelines and processes
  • Leadership experience
  • In-depth expertise on local health authority management
  • Project management skills and leadership skills
  • proven experience in managing e.g., regulatory submissions, timelines and cross-functional teams to ensure timely and successful product registrations and compliance
  • Experience in managing ComOps Stakeholders: matching influencing style to stakeholders to maximise impact and effectiveness of GRA expertise, proactively identifying opportunities to influence stakeholders on business critical decisions and employing a systematic approach to influence key internal stakeholders based on business needs and objectives
  • Experience in successfully dealing with rapid change
  • Fluent in local language and English, oral and written
  • Relevant bachelor’s degree or equivalent secondary education e.g. natural sciences (biology, chemistry with pharmacological focus)
  • 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.

What we offer

  • Flexibility of working remotely
  • Part of a supportive and dynamic team
  • Supportive and inclusive environment
  • Opportunities for career growth
  • Flexible work arrangements
  • Diverse and global client exposure
  • Learn from experts.
Parexel - All Job Offers

Looking for more opportunities?

Search for other job offers that match your skills and interests.

Suggested Tags: Frontend Developer Secretary Talent Manager Salesforce Administrator Data Analyst
Similar Jobs for

Senior Regulatory Affairs Associate

8 matching positions

Senior Regulatory Affairs Associate

As part of Parexel Consulting, you will play a vital role in helping biopharmace...
Location
Location
Peru
Salary
Salary:
Not provided
parexel.com Logo
Parexel
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
Read More
Arrow Right

Senior Regulatory Affairs Associate

As part of Parexel Consulting, you will play a vital role in helping biopharmace...
Location
Location
India
Salary
Salary:
Not provided
parexel.com Logo
Parexel
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High level of expertise in the lifecycle management of radiopharmaceutical products, including CMC authoring, safety labelling experience, artworks annotations
  • Assess change controls, author and prepare submission documentation, respond to Health Authority queries
  • Review published outputs of regulatory packages, management of data submissions to authorities (XEVMPD, PMS, etc.) as requested
  • Effective communication and collaboration skills, and the ability to work independently.
Job Responsibility
Job Responsibility
  • Assess change controls, author and prepare submission documentation, respond to Health Authority queries
  • Review published outputs of regulatory packages, management of data submissions to authorities (XEVMPD, PMS, etc.) as requested
What we offer
What we offer
  • Flexible work arrangements
  • Opportunities for career growth
  • Supportive and inclusive environment
  • Diverse and global client exposure
  • Learn from experts
Read More
Arrow Right

Senior Regulatory Affairs Associate

As part of Parexel Consulting, you will play a vital role in helping biopharmace...
Location
Location
India
Salary
Salary:
Not provided
parexel.com Logo
Parexel
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Submitting labelling / safety variations in EU countries including UK and Ireland
  • Preparation and review of M1 documents – Cover letter, eAF , Mock-ups, Clinical Overview, Literature References
  • Handled MRP and National procedures in EU
  • Updating the labelling impacted documents - SmPC, PIL and/or Label
  • Artwork update coordination
  • Veeva experience with tracking submissions, updating status, creating HAQ’s
  • Excellent communication and CFT coordination
  • HA correspondence and checking agency websites for approved information
Job Responsibility
Job Responsibility
  • Play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape
  • Work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there
  • Partner with a diverse group of clients, and be exposed to various product types and therapeutic areas
  • Develop your skills through challenging assignments and mentorship from experienced regulatory professionals
What we offer
What we offer
  • Flexibility of working remotely
  • Supportive and dynamic team
  • Supportive and inclusive environment
  • Opportunities for career growth
  • Flexible work arrangements
  • Diverse and global client exposure
  • Learn from experts
Read More
Arrow Right

Senior Regulatory Affairs Associate

As part of Parexel Consulting, you will play a vital role in helping biopharmace...
Location
Location
Spain
Salary
Salary:
Not provided
parexel.com Logo
Parexel
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • University degree in a life science discipline
  • Minimum 5 years' experience in Portuguese Regulatory Affairs, with strong understanding of Portuguese and EU regulatory requirements
  • Proven experience with multiple submission types: CP, MRP, DCP, and National procedures
  • Comprehensive lifecycle management expertise for Portuguese submissions
  • Experience with INFARMED submission processes and requirements
  • Competence in labelling management (updates, mock-up review, and print release processes)
  • Medical device knowledge advantageous, but not essential
  • Familiarity with systems such as Veeva Vault
  • Excellent organizational, time management, and interpersonal skills in a global environment
  • Proven ability to work effectively both independently and in teams
Job Responsibility
Job Responsibility
  • Provide local inputs to develop and execute innovative regulatory strategies for new product registrations and lifecycle management activities
  • Ensure strict compliance with local regulations and actively participate in policy activities with industry groups and trade associations
  • Act as RA representative in audits/inspections, ensuring readiness and timely CAPA closure
  • Monitor regulatory landscape changes and communicate requirements to Global Regulatory Affairs (GRA) and local teams
  • Serve as primary interface with INFARMED (Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.), industry groups, and trade associations
  • Lead in-country regulatory processes for licenses, partner regulatory licenses, and market access collaborations
  • Prepare and coordinate local-specific documentation (e.g., Module 1) to meet national submission requirements
  • Monitor status of submitted regulatory activities and ensure timely completion
  • Manage comprehensive lifecycle activities including variations, renewals, PSURs, and PIP submissions
  • Ensure timely submission of renewals and mandated post-approval applications
What we offer
What we offer
  • Flexible work arrangements
  • Opportunities for career growth
  • Supportive and inclusive environment
  • Diverse and global client exposure
  • Learn from experts
Read More
Arrow Right

Senior Regulatory Affairs Associate - France Local Regulatory Responsible Person

As part of Parexel Consulting, you will play a vital role in helping biopharmace...
Location
Location
France , Remote
Salary
Salary:
Not provided
parexel.com Logo
Parexel
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • University degree in a life science discipline
  • Minimum 5 years' experience in French Regulatory Affairs, with strong understanding of French and EU regulatory requirements
  • Proven experience with multiple submission types: CP, MRP, DCP, and National procedures
  • Comprehensive lifecycle management expertise for French submissions
  • Experience with ANSM submission processes and requirements
  • Competence in labelling management (updates, mock-up review, and print release processes)
  • Medical device knowledge advantageous, but not essential
  • Familiarity with systems such as Veeva Vault
  • Excellent organizational, time management, and interpersonal skills in a global environment
  • Proven ability to work effectively both independently and in teams
Job Responsibility
Job Responsibility
  • Provide local inputs to develop and execute innovative regulatory strategies for new product registrations and lifecycle management activities
  • Ensure strict compliance with local regulations and actively participate in policy activities with industry groups and trade associations
  • Act as RA representative in audits/inspections, ensuring readiness and timely CAPA closure
  • Monitor regulatory landscape changes and communicate requirements to Global Regulatory Affairs (GRA) and local teams
  • Serve as primary interface with ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé), industry groups, and trade associations
  • Lead in-country regulatory processes for licenses, partner regulatory licenses, and market access collaborations
  • Prepare and coordinate local-specific documentation (e.g., Module 1) to meet national submission requirements
  • Monitor status of submitted regulatory activities and ensure timely completion
  • Manage comprehensive lifecycle activities including variations, renewals, PSURs, and PIP submissions
  • Ensure timely submission of renewals and mandated post-approval applications
What we offer
What we offer
  • Flexible work arrangements
  • Opportunities for career growth
  • Supportive and inclusive environment
  • Diverse and global client exposure
  • Learn from experts
Read More
Arrow Right

Senior Regulatory Affairs Associate - Spain Local Regulatory Responsible Person

As part of Parexel Consulting, you will play a vital role in helping biopharmace...
Location
Location
Spain , Madrid
Salary
Salary:
Not provided
parexel.com Logo
Parexel
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • University degree in a life science discipline
  • Minimum 5 years' experience in Spanish Regulatory Affairs, with strong understanding of Spanish and EU regulatory requirements
  • Proven experience with multiple submission types: CP, MRP, DCP, and National procedures
  • Comprehensive lifecycle management expertise for Spanish submissions
  • Experience with AEMPS submission processes and requirements
  • Competence in labelling management (updates, mock-up review, and print release processes)
  • Medical device knowledge advantageous, but not essential
  • Familiarity with systems such as Veeva Vault
  • Excellent organizational, time management, and interpersonal skills in a global environment
  • Proven ability to work effectively both independently and in teams
Job Responsibility
Job Responsibility
  • Provide local inputs to develop and execute innovative regulatory strategies for new product registrations and lifecycle management activities
  • Ensure strict compliance with local regulations and actively participate in policy activities with industry groups and trade associations
  • Act as RA representative in audits/inspections, ensuring readiness and timely CAPA closure
  • Monitor regulatory landscape changes and communicate requirements to Global Regulatory Affairs (GRA) and local teams
  • Serve as primary interface with AEMPS (Agencia Española de Medicamentos y Productos Sanitarios), industry groups, and trade associations
  • Lead in-country regulatory processes for licenses, partner regulatory licenses, and market access collaborations
  • Prepare and coordinate local-specific documentation (e.g., Module 1) to meet national submission requirements
  • Monitor status of submitted regulatory activities and ensure timely completion
  • Manage comprehensive lifecycle activities including variations, renewals, PSURs, and PIP submissions
  • Ensure timely submission of renewals and mandated post-approval applications
What we offer
What we offer
  • Flexible work arrangements
  • Opportunities for career growth
  • Supportive and inclusive environment
  • Diverse and global client exposure
  • Learn from experts
Read More
Arrow Right

Senior Associate Regulatory Affairs

In this vital role you will support and, where appropriate, lead in the local co...
Location
Location
United Kingdom , Cambridge
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Degree educated
  • Experience in the management of marketing authorisations in the UK and the EU
  • Experience in/knowledge of developing and maintaining clinical trial documentation in UK and the EU (e.g. IMPDs, IMPD amendments) and ability to work with increasing autonomy
  • Knowledge and awareness of the relevant regulatory guidelines and legislation
  • Strong communication skills both oral and written
  • Organisational skills & developing or demonstrated regulatory project management skills
  • Experience with Veeva Vault
Job Responsibility
Job Responsibility
  • Support and, where appropriate, lead in the local coordination and execution of regulatory submissions in compliance with Amgen corporate standards and national regulatory requirements, as well as Regulatory Affairs processes and deliverables for the UK and Ireland
  • Ensure regulatory submissions are made on time and meet Amgen's corporate and local regulatory requirements and support licence and clinical trials activities
  • Contribute to and execute local filing plans
  • Act as a key contact for agency interactions for an assigned portfolio of products
  • Collate, distribute, exchange and archive regulatory information with colleagues across the business
  • Participate in regulatory and affiliate process improvements initiatives
  • Review promotion and non-promotion materials to ensure compliance with local licence, company procedures and Code of Practice
What we offer
What we offer
  • Vast opportunities to learn and move up and across our global organization
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
  • Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace
  • Fulltime
Read More
Arrow Right

Senior Associate - Regulatory Affairs

Let’s do this. Let’s change the world. In this vital role you will assist the US...
Location
Location
United States
Salary
Salary:
83974.90 - 113613.10 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Master’s degree
  • Bachelor’s degree and 2 years of Regulatory Affairs experience
  • Associate’s degree and 6 years of Regulatory Affairs experience
  • High school diploma / GED and 8 years of Regulatory Affairs experience
Job Responsibility
Job Responsibility
  • Assist US Regulatory Lead to support local regulatory activities (e.g. IND submissions and agency meetings)
  • Provide and maintain CTA/MA documentation support (e.g. initial filings, amendments, and periodic reports) in collaboration with US Regulatory Lead
  • Create and maintain product regulatory information and history documents through Amgen systems
  • Appropriately archive regulatory documents and agency communications
  • Collaborate with CRO’s / partners to support site initiation
  • Complete regulatory forms to support agency communications
  • Participate in GRT to support execution of regulatory strategy
  • Coordinate QC of regulatory documentation (e.g. briefing materials)
  • Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages)
  • Assist in template development and maintenance
What we offer
What we offer
  • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models where possible
  • Fulltime
Read More
Arrow Right