Senior Regulatory Affairs Associate Job at Parexel

Regulatory Affairs Senior Director - Global Regulatory Leader - Obesity

In this vital role you will support products in the Obesity Therapeutic Area. Gl...

Location

United States

Salary:

220356.00 - 269853.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 5 years of regulatory experience in biotech or science
Master’s degree and 8 years of regulatory experience in biotech or science
Bachelor’s degree and 10 years of regulatory experience in biotech or science

Job Responsibility

To lead GRTs within Amgen’s GRAAS organization
To independently develop a comprehensive regulatory strategy for one or more high complexity programs, typically in late-stage development and/or with multiple indications, that takes into account worldwide regulatory requirements to drive product development, global registration, achievement and maintenance of desired regional labeling, and effective regulatory agency interactions
To provide Regulatory leadership to cross-functional teams for high complexity programs with major Regulatory deliverables such as global original marketing applications
Develop and implement global regulatory product strategies designed to achieve approval and target product labeling for prioritized assets in late development with highly complex development programs
Represent GRA on the product team and other key commercialization governance bodies, guide and influence the organization to achieve Regulatory objectives
Independently develop the Global Regulatory Strategic Plan and provide regulatory input into the product’s Global Strategic Plan. Obtain input from the GRT members to develop a global regulatory strategy which supports product development, registration and lifecycle maintenance. Identify and communicate regulatory risks
Provide regulatory direction in the development of the core data sheet to align commercial objectives in the context of available and expected scientific data, regulatory guidance, and precedent
Independently lead the planning and implementation of global regulatory filings (eg, clinical trial applications, marketing applications, label extensions)
Ensure consistency of evidence-based global product communication (eg, regulatory submission documents)
Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment

What we offer

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 and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Fulltime

Associate Director Regulatory Affairs

The Associate Director is a senior people leader responsible for the operational...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree, 12 years of experience in CMC and/or Device regulatory, and 5 years of leadership experience
Master’s degree and 14 years of experience in CMC and/or Device regulatory, and 6 years of leadership experience
Bachelor’s degree, 15 years of experience in CMC and/or Device regulatory, and 7 years of leadership experience

Job Responsibility

Provide inclusive, inspiring leadership for staff within the CMC & Device Regulatory team in AIN
Attract, hire, develop, and retain top regulatory talent
foster a culture of learning, engagement, inclusion, and high performance
Ensure staff receive appropriate onboarding, development, and ongoing support
Promote behaviors and ways of working consistent with Amgen’s values and leadership attributes
Oversee and be accountable for regulatory work performed by AIN staff, including global change assessments, state and federal licensure, submission execution, periodic reporting and process enhancements
Partner closely with functional and regulatory leadership to drive strategic alignment across Amgen’s products
Ensure high-quality, timely, and compliant regulatory deliverables
Build and maintain strong partnerships with global functional leaders and internal stakeholders
Serve as a trusted and proactive cross-functional partner

What we offer

Reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment

Japan Regulatory Strategy Group Senior Manager

The Japan Regulatory Strategy Group Sr Mgr is developing and executing the regul...

Location

Japan , Tokyo

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s degree and 15 years of directly related experience including 10+ years of experience in Regulatory Affairs
Communication skills in English (TOEIC score ≥860 desirable)
Native level Japanese
Computers: Microsoft Outlook, Word, Excel, Power Point, and communication tools
Ability to develop and lead effective teams
Ability to work in matrix environments including cross-functional and global teams
Ability to work under minimal direction with a medium degree of autonomy
Analytical skills to evaluate and interpret complex situations and problems
Ability to anticipate and prevent potential problems
Ability to independently develop solutions that are thorough, practical, and consistent with functional objectives

Job Responsibility

Develops and implements the Japan regulatory strategy
Provides guidance on local mechanisms to accelerate/optimize product development and regulatory approvals
Proactively influence developing the global regulatory strategy
Consistently look for opportunities to accelerate the developments/approval
Contributes to the filing plan by advising and discussing with the local and global cross-functional teams
Leads or oversees the preparation of regulatory submissions
Ensures that regulatory submissions are made on time and meet requirements
Collaborates with Clinical Study Operations teams to support local planning and execution for clinical studies
Ensures that local labels are developed and maintained
Proactively lead to develop regulatory strategies and/or mitigate regulatory risks

Fulltime

Regulatory Writing Senior Manager

In this key role you will serve as the functional area lead on product teams, le...

Location

United States

Salary:

152684.00 - 193308.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of directly related experience
Master’s degree and 6 years of directly related experience
Bachelor’s degree and 8 years of directly related experience
Associate’s degree and 10 years of directly related experience
High school diploma / GED and 12 years of directly related experience
Experience with regulatory documents in Regulatory Affairs, Research, Development or related area
5+ years of experience in medical writing in the Biotech/Pharmaceutical industry

Job Responsibility

Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, and Pediatric Investigation Plans
Conduct the formal review and approval of authored documents, following applicable standard operating procedures
With limited supervision, lead regulatory writing activities for complex product submissions, including new and supplemental drug applications/biologics license applications
Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group)
Provide functional area input for Global Regulatory Plan and team goals
Supervise the work of contract and freelance writers and mentor junior medical writers as assigned
Lead departmental and cross-departmental initiatives, as appropriate
Generate document timelines

What we offer

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 and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Fulltime

Senior Manager, Global Medical Affairs (Menopause)

This role is pivotal in providing subject matter knowledge and expertise, develo...

Location

United Kingdom , London

Salary:

Not provided

Theramex

Expiration Date

Until further notice

Requirements

Medical degree with GMC registration or equivalent international qualification or Master of Pharmacy with GPhC registration
Previous experience in Medical Affairs, Clinical Research, or Pharmacovigilance within the pharmaceutical industry
Very good understanding of Medical Affairs’ role as scientific enabler and strategic partner in a pharmaceutical company
Strong knowledge and subject matter in women’s health
Ability to cut through scientific complexity and to communicate precisely and clearly with different target audiences
Strong interpersonal and leadership skills and track record of expertise working in a cross-functional environment
Strong analytical and strategic thinking
Strong business acumen
Highest professional work ethics
Proven knowledge of the ABPI Code of Practice and codes of international associations of the pharmaceutical industry, with experience in reviewing and/or certifying materials

Job Responsibility

Develop and implement medical plans aligned with business objectives and manage associated budgets
Provide expert medical input across the product lifecycle, including: Evidence generation
Evidence dissemination (e.g. health care professional education programs)
Medical experts’ engagement programs (e.g. advisory boards)
Build and maintain relationships with international therapy area experts and medical-scientific professional societies
Act as a medical reviewer for promotional and non-promotional materials in line with the ABPI and international associations of the pharmaceutical industry codes as well as internal SOPs
Support regulatory and market access submissions with clinical content
Ensure compliance with all relevant regulations and contribute to continuous process improvement
Ensure operational excellence

What we offer

A fast-paced environment, with broad exposure, where you can develop professionally – even outside your area of expertise
We support you as you grow and learn, and we love to celebrate success and recognize performance
We provide opportunities for driven and talented professionals who want to be part of our exciting journey

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 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

Regulatory Data & Systems Manager

The Regulatory Data & Systems Manager will be responsible for facilitating syste...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Strong interpersonal and teamwork skills, with the ability to interact with business users, technical IT groups, project managers, senior management, outsourced service providers, and vendors
5+ years' experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & agile systems development methodologies
Excellent oral and written communication skills
able to organize and present ideas in a convincing and compelling manner
Ability to operate effectively in a matrix environment
team player yet able to work independently with minimal direction
Familiarity with GxP requirements and systems validation
Life Sciences, Biotech or pharmaceutical industry experience preferred
Proven Veeva Vault knowledge
Bachelor’s degree and 2 years of directly related experience

Job Responsibility

System Administration: Manage and maintain the organization's IT systems, ensuring they are secure, efficient, and compliant with regulatory requirements
Regulatory Business Analysis: Interpret and implement regulatory requirements, ensuring all systems and processes adhere to relevant regulatory requirements and industry best practices
Project Coordination: Assist in planning, tracking, and executing departmental projects and initiatives
Stakeholder Communication: Liaise with internal and external stakeholders to ensure timely and accurate communication regarding regulatory requirements and system updates

What we offer

Reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment

Senior Regulatory Affairs Associate

Parexel

Location:

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
February 18, 2026

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