Ra Strategy Expert Job at Product Life Group

Japan Regulatory Strategy Manager

Japan Regulatory Affairs provides leadership, expertise, and execution for the r...

Location

Japan , Tokyo

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s degree and 10+ years of directly related experience including 5+ years of experience in Regulatory Affairs
In-depth regulatory experience
Knowledge of Japan legislation and regulations relating to medicinal products
Knowledge of drug development Scientific/Technical Excellence
Teamwork
Communication skills both oral and written
Ability to understand and communicate scientific/clinical information
Ability to 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

Job Responsibility

Develops and implements the Japan regulatory strategy, aligned with global regulatory strategy as much as possible
Provides guidance on local mechanisms to accelerate/optimize product development and regulatory approvals
Proactively influence developing the global regulatory strategy so that Japan developments are aligned
Consistently look for opportunities to accelerate the developments/approval and/or increase the value of the program to serve for more patients
As a representative of the Japan Regulatory Strategy Group, contributes to the filing plan by advising and discussing with the local and global cross-functional teams
Leads the preparation of regulatory submissions, which may include New Drug Applications (NDAs), briefing documents for various types of PMDA consultations, Clinical Trial Notifications (CTNs), and Orphan Drug Applications in Japan according to the filing plan
Ensures that regulatory submissions are made on time and meet Amgen’s corporate and local regulatory requirements
Collaborates with Clinical Study Operations teams to support local planning and execution for clinical studies in accordance with national legal and regulatory requirements
Ensures that local labels are developed and maintained in line with local regulations and Amgen standards and procedures
Proactively lead to develop regulatory strategies and/or mitigate regulatory risks across RA Japan and/or across Amgen

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

Fulltime

Senior Director, Global Medical Affairs – Front Line Care

Senior Director, Global Medical Affairs – Front Line Care (FLC) is the senior me...

Location

United States , Skaneateles Falls

Salary:

280000.00 - 385000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

8-10+ years of industry experience, including meaningful experience in MedTech
5+ years of strategic leadership/management experience, including people leadership in a matrixed environment
Demonstrated experience developing and implementing global evidence roadmaps
Leading/partnering on clinical evidence strategy, scientific communications, and cross-functional decision-making
Strong understanding of the U.S. and Global regulatory and healthcare environment including EuMDR and notified bodies requirements
Proven track record to operate with high integrity and in alignment with compliance standards
Demonstrate solid proficiency in study build, clinical trial methodology
Applicants must be authorized to work for any employer in the U.S.
We are unable to sponsor or take over sponsorship of an employment visa at this time

Job Responsibility

Define and implement the FLC Global Medical Affairs strategic plan and critical evidence priorities
Provide senior medical leadership and decision support for business strategy, innovation, and new product development
Translate clinical, scientific, and customer insights into clear strategic recommendations and measurable execution plans
Ensure strong expertise in study build, clinical trial methodology, and evidence-generation guidelines
Develop global clinical evidence roadmap enabling execution of the global business priorities
Lead the evidence-generation strategy across the product lifecycle
Accountable for Baxter-sponsored clinical research for FLC, ensuring scientific integrity and compliance with Good Clinical Practice (GCP)
Create appropriate partnerships internally and externally to develop health economics & outcomes research (HEOR) needs
Develop and lead 3rd party relationships (e.g. CROs) as required to implement study deliverables
Serve as a senior representative for FLC with KOLs, professional societies, advisory boards, and scientific conferences

What we offer

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on length of service
Family and medical leaves of absence
Paid parental leave

Fulltime

Senior Director, Global Medical Affairs – Front Line Care

Senior Director, Global Medical Affairs – Front Line Care (FLC) is the senior me...

Location

United States , Skaneateles Falls

Salary:

280000.00 - 385000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

8-10+ years of industry experience, including meaningful experience in MedTech
5+ years of strategic leadership/management experience, including people leadership in a matrixed environment
Demonstrated experience developing and implementing global evidence roadmaps
Leading/partnering on clinical evidence strategy, scientific communications, and cross-functional decision-making
Strong understanding of the U.S. and Global regulatory and healthcare environment including EuMDR and notified bodies requirements
Proven track record to operate with high integrity and in alignment with compliance standards
Demonstrate solid proficiency in study build, clinical trial methodology
Applicants must be authorized to work for any employer in the U.S.
We are unable to sponsor or take over sponsorship of an employment visa at this time

Job Responsibility

Define and implement the FLC Global Medical Affairs strategic plan and critical evidence priorities in collaboration with business partners
Provide senior medical leadership and decision support for business strategy, innovation, and new product development across the FLC portfolio and regions
Translate clinical, scientific, and customer insights into clear strategic recommendations and measurable execution plans
Ensure strong expertise in study build, clinical trial methodology, and evidence-generation guidelines
Develop global clinical evidence roadmap enabling execution of the global business priorities
Lead the evidence-generation strategy across the product lifecycle (pre-launch through post-market)
Accountable for Baxter-sponsored clinical research for FLC, ensuring scientific integrity and compliance with Good Clinical Practice (GCP)
Create appropriate partnerships internally and externally to develop health economics & outcomes research (HEOR) needs and execution for HEOR evidence
Develop and lead 3rd party relationships (e.g. CROs) as required to implement study deliverables
Serve as a senior representative for FLC with KOLs, professional societies, advisory boards, and scientific conferences

What we offer

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on length of service
Family and medical leaves of absence
Paid parental leave

Fulltime

Senior Manager of Global Regulatory Affairs

A Senior Manager of Global Regulatory Affairs leads the development and executio...

Location

United States , Deerfield

Salary:

136000.00 - 187000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree or country equivalent in a scientific discipline
Minimum of 7-year experience in RA
Expert Regulatory knowledge
Sound basis of Scientific (Training/ Communications) knowledge
Management skills
Ability to oversee multiple projects in a matrix team environment
Excellent oral and written communication and presentation skills
Demonstrated excellent interpersonal and collaboration skills, including diplomacy to negotiate conflicting priorities
Technical and management skills
Ability to lead, coach, and motivate others

Job Responsibility

Serves as the Global Regulatory Lead for Baxter’s hemostat and sealant product(s) registered as biologic/combination products
Provide technical and strategic input for regulatory decisions aligned with business strategy
Identify & prioritize key areas of risk and probability of occurrence as well as ensure implementation of mitigation plans and follow ups
Monitor, evaluate, and interpret all applicable regulatory requirements, assure compliance with Baxter and external standards
Assess impact of new regulations and provide feedback
Evaluate technical and scientific information, identify deficiencies, implement and execute strategies to remediate risks
Act as primary contact for meetings with regulatory authorities including planning and leadership
Maintain appropriate communication within the RA function, with Global Marketing, and with other functions primarily at the project team level
Plan and manage complex projects and prioritize workload
Initiate, manage and maintain operational activities in support of new and existing marketing authorizations

What we offer

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on length of service
Family and medical leaves of absence
Paid parental leave

Fulltime

Senior Manager of Global Regulatory Affairs

A Senior Manager of Global Regulatory Affairs leads the development and executio...

Location

United States , Deerfield

Salary:

136000.00 - 187000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree or country equivalent in a scientific discipline
Minimum of 7-year experience in RA
Expert Regulatory knowledge
Sound basis of Scientific (Training/ Communications) knowledge
Management skills
Ability to oversee multiple projects in a matrix team environment
Excellent oral and written communication and presentation skills
Demonstrated excellent interpersonal and collaboration skills, including diplomacy to negotiate conflicting priorities
Technical and management skills
Ability to lead, coach, and motivate others

Job Responsibility

Serves as the Global Regulatory Lead for Baxter’s hemostat and sealant product(s) registered as biologic/combination products
Provide technical and strategic input for regulatory decisions aligned with business strategy
Identify & prioritize key areas of risk and probability of occurrence as well as ensure implementation of mitigation plans and follow ups
Monitor, evaluate, and interpret all applicable regulatory requirements, assure compliance with Baxter and external standards
Assess impact of new regulations and provide feedback
Evaluate technical and scientific information, identify deficiencies, implement and execute strategies to remediate risks
Act as primary contact for meetings with regulatory authorities including planning and leadership
Maintain appropriate communication within the RA function, with Global Marketing, and with other functions primarily at the project team level
Plan and manage complex projects and prioritize workload
Initiate, manage and maintain operational activities in support of new and existing marketing authorizations

What we offer

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on length of service
Family and medical leaves of absence
Paid parental leave

Fulltime

Clinical Research Associate II

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part t...

Location

India , Bengaluru

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Substantial start up experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology
Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience
Demonstrate strong problem-solving skills
Able to take initiative and work independently, and to proactively seek guidance when necessary
Excellent presentation skills
Client focused approach to work
Ability to interact professionally within a client organization
Flexible attitude with respect to work assignments and new learning
Ability to prioritize multiple tasks and achieve project timelines
utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise

Job Responsibility

Act as Parexel’s direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase
Build relationships with investigators and site staff
Support on request country specific feasibility and/or site pre-qualification and qualification activities
Manage country and site level TMF issues ensuring documents’ First Time Quality (FTQ) as well as providing direct resolution to reported site problems
Develop strategy to configure, distribute, collect, and review and approve, high quality country specific and/or site specific documents or essential regulatory documents
Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF), translations, and customize and negotiate any amendments
Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval
Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy
Forecast, develop, manage, and revise plans and strategies for IRB/IEC and MoH / RA submission/approval and Site activation
Update and maintain appropriate Clinical Trial Management System (CTMS) in a timely manner

What we offer

Patient-focused in everything we do
Supportive and inclusive environment
Career growth and development
Flexible work arrangements
Diverse therapeutic areas and project exposure
Advanced Technology

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

Senior Manager, Central Regulatory Affairs

The Sr. Manager - Central RA is a pivotal senior leadership role based out of Ba...

Location

India , Bangalore

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Advanced degree in Pharmacy, Life Sciences, Biotechnology, Regulatory Affairs, or related discipline
12+ years of progressive experience in global regulatory affairs within the pharmaceutical, biotechnology, or medical device industry, with significant people management and team development
Expert knowledge of global regulatory requirements and guidelines (FDA, EMA, TGA, MHRA, etc.), with a strong track record of successful regulatory submissions and approvals
Proven leadership skills with the ability to influence and collaborate effectively across diverse global teams and stakeholders
Strategic thinker with the ability to navigate complex regulatory challenges and drive regulatory initiatives that support business growth and compliance objectives

Job Responsibility

Develop and implement global regulatory strategies for Baxter products (both Drugs and Devices) aligned with business objectives to support product lifecycle spanning timely Initial /Geo-expansion/ Change controls and Variations registrations enabling speedy commercialization across diverse markets
Drive transformation initiatives to improve regulatory processes and ensure compliance with changing regulatory requirements
Collaborate with cross-functional teams to identify opportunities for innovation and implement solutions
Lead the preparation and submission of regulatory documents, including lifecycle management submissions, to regulatory authorities globally
Ensure that all submissions are accurate, complete, and compliant with regulatory requirements
Engage and collaborate with cross-functional teams, including R&D, Quality, and Manufacturing, to gather necessary information and ensure alignment
Oversee the preparation, review, and submission of both Drug and Device Lifecycle management regulatory filings (e.g., Initial and Geo-expansion registrations, change controls, Variations, Tender support, Acquisition Integration /Divestiture related Legal Entity name changes etc.) to health authorities across global markets
Ensure timely approvals and compliance with regulatory standards and post-market requirements across multiple jurisdictions
Establish and maintain standardized regulatory processes, procedures, and documentation within Central RA to drive operational efficiency and regulatory compliance across GRA
Generate future readiness with implementation of best practices and continuous improvement initiatives to optimize regulatory operations and ensure consistency across regions for registrations, Change Control Management, tender Support, Geo-expansion/Initial registrations

Ra Strategy Expert

Product Life Group

Location:
Netherlands

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
April 16, 2026

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