Senior Regulatory Affairs Associate Job at Parexel

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 Associate

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

Location

India

Salary:

Not provided

Parexel

Expiration Date

Until further notice

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

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

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

Senior Regulatory Affairs Associate

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

Location

India

Salary:

Not provided

Parexel

Expiration Date

Until further notice

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

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

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

Senior Regulatory Affairs Associate

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

Location

Salary:

Not provided

Parexel

Expiration Date

Until further notice

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)

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.

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.

Senior Regulatory Affairs Associate

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

Location

Spain

Salary:

Not provided

Parexel

Expiration Date

Until further notice

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

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

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

Senior Regulatory Affairs Associate - France Local Regulatory Responsible Person

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

Location

France , Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

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

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

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

Senior Regulatory Affairs Associate - Spain Local Regulatory Responsible Person

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

Location

Spain , Madrid

Salary:

Not provided

Parexel

Expiration Date

Until further notice

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

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

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

Senior Associate Regulatory Affairs

In this vital role you will support and, where appropriate, lead in the local co...

Location

United Kingdom , Cambridge

Salary:

Not provided

Amgen

Expiration Date

Until further notice

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

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

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

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Senior Regulatory Affairs Associate

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