Senior Regulatory Affairs Associate- Clinical Trial Application Job at Parexel

Senior Regulatory Affairs Associate - Clinical Trial Applications (CTA)

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

Location

South Africa , Bloemfontein

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

University degree in a science discipline
Background in clinical trial management
Innitial years of Regulatory Affairs experience working with Clinical Trail Applications in South Africa - must
Experience with clinical trial submissions in other Southern African Countries - preferred
Good level of knowledge of the CTA business in addition, an expertise/skill in cross-functional project management and planning, process optimization
IT knowledge (Veeva Regulatory and Clinical Vaults - excel – VBA – powerBI)
Solid analysis and synthesis capability
Solution-oriented and problem-solving skills
Customer-oriented and autonomous
Fluency in English is a must along with the local language.

Job Responsibility

Manage the local submissions (as Local Regulatory Contact - LRC) but should also be able to coordinate the regulatory submissions in all participating countries as Regulatory Lead
Regulatory submission of Clinical Trial in South Africa
Participate in Regulatory Operations meetings, project team meetings, and maintain relationships with other departments, clients, and regulatory agencies as necessary
May be involved in local, regional, and/or global projects

Fulltime

Senior Associate Regulatory Affairs

Join our team at AMGEN Capability Center Portugal. Amgen's Regional Regulatory A...

Location

Portugal , Lisbon

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree or Bachelor’s degree (scientific area) and 3 years of directly related experience
Demonstrated experience in clinical trial regulatory affairs
Previous experience in developing and maintaining CTA documentation in Europe (e.g. IMPDs, IMPD amendments) is ideal
Depth knowledge of EU legislation and regulations relating to medicinal products is ideal
Adaptability and strong English communication skills, both oral and written

Job Responsibility

Execute the EU regulatory strategy and EU regulatory plans
Prepare supportive documentation for regulatory deliverables, including the management of clinical trial applications, marketing authorizations, and lifecycle management activities
Use of Amgen systems and document management
Ensure and support regulatory product compliance
Work with policies and SOPs
Build effective relationships and communication paths across local and functional organizations
Enable efficiencies and seamless execution across the region countries

What we offer

Vast opportunities to learn, develop, and move up and across our global organization
Diverse and inclusive community of belonging
Generous AMGEN Total Rewards Plan comprising healthcare, finance, wealth, and career benefits
Flexible work arrangements

Clinical Trials Regulatory Submission Senior Associate

In this vital role you will be responsible for performing Regulatory submissions...

Location

Argentina , Buenos Aires

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree
OR Bachelor’s degree and 5 years of Clinical Trials experience
Minimum 3 years of regulatory submissions and/or study start-up experience is required with strong technical knowledge performing Clinical Trial Applications in Argentina (ANMAT, CCIS)
Excellent written and verbal communication skills in English
Experience and/or technical knowledge in Import License extensions is a strong plus
Ability to plan, develop, and manage timelines, including keeping them up to date
Comfortable managing multiple projects and priorities at the same time
Skilled at building and maintaining positive relationships with health authorities, colleagues, managers, and service providers
Able to work independently and asynchronously across time zones in a collaborative, matrixed team environment

Job Responsibility

Performing Regulatory submissions in Argentina to ANMAT/ CCIS
Compiling submission dossier
Execution of all regulatory activities for clinical trial projects and programs, according to local regulations and Amgen’s policy
Interacting directly with Functional Service Providers for Ethics Committee Services, Clinical Project Management (Local Trial Managers), Global Study Operations, International Regulatory Team, CMC Global Product Leads, Pharmacovigilance, Clinical Supply Chain and vendors acting as Importer of Record
Performing efficiently end-to-end Clinical Trials Regulatory submissions in country for new and ongoing project(s) or programs
Submitting, with the input of importer of record, study specific import licenses extensions until approvals
Communicating overall regulatory status to internal teams and service providers
Attending to project meetings with cross functional department leads to provide regulatory timelines and requirements for regulatory submissions and approvals
Collaborating with internal team members to establish timelines and clarify regulatory requirements
Maintaining clinical trial regulatory requirements' database, including regular updates to checklists

What we offer

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

Fulltime

Regulatory Affairs Senior Manager – Obesity and Related Conditions

Amgen is seeking a United States Regulatory Lead (USRL) supporting products in t...

Location

United States , Remote; Deerfield; Washington D.C.

Salary:

142579.00 - 192901.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of regulatory experience
Master’s degree and 4 years of regulatory experience
Bachelor’s degree and 6 years of regulatory experience
Associate’s degree and 10 years of regulatory experience
High school diploma / GED and 12 years of regulatory experience
Demonstrated experience with U.S. regulatory submissions and direct FDA interaction, with strong knowledge of the U.S. regulatory environment and drug development lifecycle
Experience contributing to regulatory strategy, including risk assessment, scenario planning, and Health Authority engagement in partnership with global leadership.

Job Responsibility

Contribute to the development and refinement of global regulatory strategy in partnership with the GRL, providing U.S.-specific insights on regulatory precedent, risk, and Health Authority expectations in obesity and related metabolic conditions
Apply scientific expertise in obesity and metabolic disease to inform regulatory strategy, including clinical endpoints and long-term safety considerations
Partner with the GRL and key market leads to align on global development timelines, core documents (e.g., protocols, IBs, KDEs), and regulatory positioning
Execute the U.S. regulatory strategy for assigned programs and represent the region on global governance teams
Plan and lead U.S. regulatory submissions (e.g., clinical trial and marketing applications) in alignment with global filing plans and regulatory requirements
Lead development of key regulatory documents, including labels, briefing packages, and submission components aligned with product strategy
Drive U.S. labeling strategy and execution in collaboration with the Labeling Working Group, including negotiation approach, timelines, and deviation/waiver decisions
Provide strategic input on U.S. development pathways (e.g., expedited programs, orphan designation, pediatric strategy), informed by the evolving regulatory landscape
Lead Health Authority interactions for assigned products, including preparing and leading engagements and communicating outcomes to the GRT and senior management
Manage responses to agency questions (RTQs) and feedback by coordinating cross-functional input and ensuring timely, high-quality submissions

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

Senior Manager Regulatory Affairs CZ&SK

Senior Manager Regulatory Affairs CZ&SK. Czech Republic - Prague. SALARY RANGE: ...

Location

Czech Republic , Prague

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of directly related experience OR Master’s degree and 6 years of directly related experience OR Bachelor’s degree and 8 years of directly related experience
Degree and in-depth regulatory experience and/or related to the affiliate
Depth knowledge of affiliate legislation and regulations relating to medicinal products
English and Czech and/or Slovak language working proficiency
Good negotiation and Influencing skills
Ability to anticipate and prevent potential issues
Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
Cultural awareness and sensitivity to achieve results across both regional, affiliate and international borders
Ability to manage multiple activities and set priorities
Ability to lead teams and develop effective teams

Job Responsibility

Provides affiliate regulatory expertise and execution for the development, registration, and lifecycle management of all Amgen molecules
Oversee the affiliate and manage a regulatory team to ensure delivery of assigned local and ELMAC Regulatory initiatives
First point of contact for interactions with local regulatory agency(ies)
Ensure that the local Regulatory staff delivers assigned local and ELMAC Regulatory initiatives across the affiliates
Represent Regulatory on the affiliate leadership team
Provide local regulatory input to support development and execution of assigned Regulatory Affairs initiatives and effective interactions with key regulatory agency(ies)
Supervise and oversight for one or more regulatory staff
Manage and liaising with distributors (if applicable)
Translates assigned global, regional and ELMAC Regulatory initiatives into local regulatory objectives where applicable
Acts as senior point of contact for local regulatory advice on commercial and medical activities within the affiliate

Fulltime

Senior Clinical Research Associate

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

Canada , MONTREAL, TORONTO, VANCOUVER, BURLINGTON, BRITISH COLUMBIA, NEW BRUNSWICK, QUEBEC

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Undergraduate degree or its international equivalent in clinical, science, or health related field from an accredited institution
a licensed healthcare professional (i.e., registered nurse)
or equivalent work experience required
1+ years of clinical monitoring experience or equivalent combination of education and experience is required for the level 2 role
3+ years is required for a level 3
ONCOLOGY MONITORING EXPERIENCE PREFERRED
ABILITY TO TRAVEL 70%
Knowledge of ICH and local regulatory authority regulations regarding drug trials
To qualify, applicants must be legally authorized to work in the United States or Canada, and should not require, now or in the future, sponsorship for employment visa status

Job Responsibility

Monitor the progress of clinical studies, either at investigative sites or remotely
Ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments

Fulltime

Senior Regulatory Sciences Specialist

Senior Regulatory Sciences Specialist is responsible for end-to-end regulatory s...

Location

Taiwan , Taipei

Salary:

Not provided

Pfizer

Expiration Date

Until further notice

Requirements

Bachelor degree or above, major in pharmacy or other science-related background
2-3 years regulatory related experience
TOEIC Score≧650
Professional expertise in local pharmaceutical regulations
Good communication skill
Problem solving
Project Management
Teamwork
Strategic thinking
Negotiation

Job Responsibility

Provide strategic product direction and interact with regulatory agencies to expedite approval of pending registrations
Represent regulatory interests to marketing, research project teams, and government agencies throughout the product lifecycle
Develop and submit product registrations, progress reports, supplements, amendments, and periodic experience reports
Provide input to stakeholders for product development in line with business objectives, ensuring strategies are reflected in country plans and aligned with regulatory activities and commercial goals
Support the development of Regulatory Affairs by maintaining internal databases, tracking systems, and document management, and offering regulatory inputs for promotional material approval
Oversee clinical trial applications, manage queries and commitments with stakeholders, and ensure manufacturing and packaging projects are approved on time, maintaining licenses in compliance with local regulations
Participate the development of the registration plans for NDA, LE and PMF and implement them timely and effectively with the guidance from line manager
Partner with cross-functional teams for readiness of the change implementation
Ensure the assigned products and GMPs are maintained in full compliance with local regulations and company SOPs
Ensure key changes of the assigned products are closely communicated with relevant internal stakeholders to ensure readiness of change implementation

Fulltime

Senior Study Start Up Associate

Study Start Up Associate I- IND Submission-Home based-South Korea- ICON Strategi...

Location

South Korea , Seoul

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in life sciences or a related field
Previous experience in clinical research or regulatory affairs preferred, but not required
Strong attention to detail and organizational skills
Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams
Ability to work independently and manage multiple tasks simultaneously in a fast-paced environment

Job Responsibility

Assisting in the preparation and submission of regulatory documents, such as clinical trial applications and ethics committee submissions
Coordinating with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation
Maintaining accurate and up-to-date records of regulatory submissions and approvals
Supporting study teams in the development of study documents, including protocols, informed consent forms, and investigator brochures
Participating in study start-up meetings and providing input on regulatory requirements and timelines

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

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Senior Regulatory Affairs Associate- Clinical Trial Application

Job Description

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