Regulatory Submissions Manager Job at iconplc (Yerevan)

Regulatory Submissions Manager

Regulatory Affairs Manager (FSP Global Pharma), Home-based in Australia. ICON pl...

Location

Australia , Sydney

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a scientific or healthcare-related field
advanced degree preferred
Minimum of 6 years of experience in regulatory affairs within the pharmaceutical or Biotechnology industry
Prior experience with various regulatory submissions, including CTA/IND/MAA
Ability to lead internal teams and carry out regulatory activities independently
Strong understanding of global regulatory requirements and guidelines

Job Responsibility

Lead regulatory activities and submissions independently, with prior experience in areas such as CTA/IND/MAA
Provide regulatory guidance and efforts to internal teams
Participate in agency interactions and regulatory submissions
Contribute to developing best practices within ICON Regulatory Affairs through your insight of regulatory processes and guidelines
Work collaboratively as part of a regulatory or cross-functional team, depending on project size and nature

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

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

Manager, Regulatory Affairs

Location

South Korea , Seoul

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s in Pharmacy or equivalent in a health-related field plus 6-7 years of clinical trials experience
within the total years of experience, at least 3-4 years of regulatory submissions experience is required
Strong technical knowledge and 3-4 years of experience in executing Clinical Trial Applications in Korea
(preferred) Experience in preparing, attending and responding to GCP Inspection
Good written and verbal communication skills in English
Degree and in-depth regulatory experience and/or related to the country
Depth knowledge of country legislation and regulations relating to medicinal products
Ability to conceptualize, develop and manage timelines, including its updates
Ability to delegate and make decisions, including risk-based ones
Ability to manage multiple projects and priorities

Job Responsibility

Efficiently end-to-end manages Clinical Trials Regulatory submission in Korea for new and ongoing project(s) or programs, including and not limited to initial applications, clinical protocol amendments, ICF amendments, quality (CMC) amendments, study periodic reporting, until the project is officially closed
Develops, with the input of importer of record, study specific import licenses approvals and keeps it updated
Monitors efficiency, quality and adherence to project timelines, SOPs and local regulations
Attends to regulatory inspections and corporate audits, representing the RA function
Communicates overall regulatory status to internal teams and service providers
Attends to project meetings with cross functional department leads to provide strategy, timelines and requirements for regulatory submissions and approvals
Works with internal team members to establish and clarify regulatory requirements
Responsible for clinical trial regulatory intelligence, including regular updates to databases
Coordinate with local and global team CTA pre-submission meetings with Agency, if needed
Where applicable, provides work instructions to related team members in preparation of regulatory submissions, timeline estimations, issues resolution, etc

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 Manager, Regulatory Affairs (Ad Promo)

As a Senior Manager, Regulatory Affairs at ICON, you will design and analyse cli...

Location

United States , Raleigh

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a relevant scientific discipline or healthcare-related field
EU/APAC: In-depth proven regulatory affairs expertise. Minimum of 7 years' experience, supervisory experience, and pharmaceutical/CRO industry experience
US/LATAM/CAN: A minimum of 7 years regulatory affairs experience including supervisory experience and a minimum of 6 years pharmaceutical/CRO industry
Demonstrable experience within regulatory affairs, including development of regulatory strategies, document writing, marketing authorization applications, clinical trials, post-licensing activities, and direct regulatory agency interaction
Strong organizational skills, ability to manage multiple tasks, and meticulous attention to detail
Excellent written, verbal, and management skills, as well as demonstrated presentation skills, problem-solving ability, strong interpersonal skills, and the ability to plan/organize

Job Responsibility

Participate in provision of regulatory expertise in strategic drug development across multiple areas
Take part in preparation of strategic development and submission plans
Be involved in the regulatory affairs activities across the ICON portfolio and be an expert and advisor to ICON clients (externally and internally)
Be a trusted partner - represent the Regulatory Affairs Department in business development activities and generate new business opportunities
Contribute to at least two of the following areas: interactions with regulatory agencies, early phase consulting, development planning (PDP/RDP/CDP), scientific/agency advice, orphan drugs/pediatric development, medical devices

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

Program Manager, Regulatory Remediation and Transformation

This role is of Assistant Vice President in Regulatory Remediation Task Force: T...

Location

India , Mumbai

Salary:

Not provided

Citi

Expiration Date

Until further notice

Requirements

~5-7 years’ experience in banking or financial services, with demonstrated involvement in regulatory reporting, remediation projects, or project management
Proven analytical skills and problem-solving capabilities, with a detail-oriented approach to execution
Experience working collaboratively within cross-functional teams in complex regulatory environments
Foundational knowledge of data governance principles, regulatory standards, and RBI reporting requirements
Solid project management and coordination support experience, with an ability to manage multiple tasks and deliverables effectively

Job Responsibility

Drive day-to-day execution of assigned reporting and remediation deliverables, ensuring accuracy, timeliness, and audit readiness of submissions
Coordinate across functions including business units, data analytics teams, and technology partners, to identify and close data and process gaps
Provide project management support to automation initiatives, such as Advances Indent automation in RegInsight and other similar efforts, ensuring systematic and efficient delivery
Maintain comprehensive documentation, controls, and evidence for internal and external (regulator and audit) reviews
Provide PM support to Advances Indent automation in RegInsight and other similar automation initiative
Provide support for stakeholder engagement, regulatory interactions, and executive briefings as directed by senior leadership
Maintain a working understanding of business-level specifics, including key RBI reports, their relevance, and relationships within the regulatory landscape

Fulltime

(Senior) Manager, Regulatory Affairs

We are working with a leading pharmaceutical company who are seeking an experien...

Location

United Kingdom , Maidenhead

Salary:

70.00 - 85.00 GBP / Hour

SRG

Expiration Date

Until further notice

Requirements

Degree in pharmacy, biology, chemistry, pharmacology, or related life sciences discipline
Strong experience in European Regulatory Affairs, including centralised, MRP/DCP and national procedures
Proven track record leading regulatory activities for development products (e.g., scientific advice, PIP)
Effective communicator able to work across complex international and matrixed environments
Strong leadership, organisational skills and ability to work independently with minimal supervision

Job Responsibility

Lead the development and implementation of regulatory strategies and risk assessments for assigned products across the Europe Area
Represent regional regulatory requirements within global regulatory project teams to ensure appropriate consideration in global strategy
Collaborate with affiliate Regulatory Affairs teams to guide submissions, health authority interactions and life-cycle management activities
Assess scientific data for regulatory submissions, identify gaps, and develop mitigation strategies to support approvals
Monitor evolving European legislation and lead the development of regulatory responses and policy implementation

Parttime

Manager, Regulatory Affairs & Quality Assurance

NYES is seeking an accountable and specialized Manager of Regulatory Affairs & Q...

Location

United States , Brooklyn

Salary:

Not provided

New York Embroidery Studio

Expiration Date

Until further notice

Requirements

5–10 years of specific experience in Regulatory Affairs for PPE manufacturing, with a proven track record of successful FDA clearances
Comprehensive knowledge of FDA Class I and II medical device classifications, ASTM testing methods, and NIOSH approval standards
Strong background in implementing and maintaining Quality Management Systems (QMS) compliant with federal standards (21 CFR 820) and international standards (ISO 13485)
RAPS (Regulatory Affairs Certification) and Six Sigma Black Belt (preferred)
A professional who seeks full accountability and can coordinate complex, cross-functional teams to achieve compliance goals

Job Responsibility

Serve as the primary lead for the development, implementation, and continuous improvement of the ISO 13485 Quality Management System, ensuring all manufacturing and quality processes maintain international certification
Lead the preparation and submission of FDA 510(k) premarket notifications for medical-grade PPE (e.g., surgical masks, isolation gowns, etc.) to ensure products are “FDA-cleared.”
Oversee adherence to 21 CFR Part 820 (Quality System Regulation) for all PPE manufacturing processes and controls
Manage the certification and approval process with NIOSH for respiratory protective devices, such as N95 respirators
Ensure materials meet rigorous ASTM International standards for barrier performance, including fluid resistance (ASTM F903) and viral penetration (ASTM F1671)
Act as the primary point of contact for government agencies, ensuring manufacturing and marketing practices align with OSHA requirements
Direct the development of labeling and packaging to ensure accurate regulatory claims and prevent the marketing of unverified equipment
Partner with product development and commercial teams to navigate registration processes and ensure timely product launches

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Regulatory Submissions Manager

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