Manager, Regulatory Lead Job at Alfasigma (Morristown)

Manager, Regulatory Lead

This position represents one or more Regions / Countries on the Regulatory Sub t...

Location

Italy , Bologna

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Bachelor’s degree (minimum 5 years relevant experience) or advanced scientific degree (MS, PhD, Pharm D
minimum 3 years relevant experience) in regulatory affairs or pharmaceutical industry and/or clinical research
Experience supporting and/or leading IND/CTA submissions
Understanding of the cross functional drug development processes (Clinical Operations, Data Management, Biostats, and Regulatory)
Strong verbal and written communications skills
Excellent project and/or program management skills
Detail-oriented and ability to achieve results across functions and levels
Ability to work effectively across a highly complex, fast paced, matrix organization
Proficiency in MS Office Suite
Learning agility and 'scalability' to take on increasing responsibility as Intercept grows

Job Responsibility

Contribute to development and local/regional implementation of regulatory strategies for a low complexity program/single asset
Support planning, coordination, and preparation for meetings, including teleconferences with locoregional regulatory agencies
Contribute to regulatory review of study documents such as protocols, protocol amendments, ICFs, CSRs, IMPDs, IBs, and annual reports to ensure content and format meet all regulatory requirements
Contribute to development of regulatory submission plans
Assist with coordination and submission of locoregional IND/CTA submissions and maintenance activities
Support product development and lifecycle management activities
Support assessment of regulatory pathways for submissions to the FDA and other regulatory agencies
Manage multiple tasks in a fast-paced environment while keeping on task and to the company's quality standards
Drive the spirit of "ONE Team" across all functions by supporting a team approach to focus on our patients and customers as our top priorities

What we offer

competitive salary
comprehensive benefits
extensive opportunities for professional growth and development

Manager- International Regulatory Lead

The International Regulatory Lead (IRL) Manager will provide regulatory leadersh...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 6 years of directly related experience
OR Master's degree and 8 years of directly related experience
OR Bachelor's degree and 10 years of directly related experience

Job Responsibility

Provide regulatory leadership & expertise for International countries for one or more Amgen products
Collaborate with various functions and local regulatory teams to optimize product development and regulatory approvals in International countries
Develop international regulatory strategy and provide regulatory support for in-country product registrations and life cycle management
Provide Guidance and Leadership on mechanisms to optimize product development and regulatory approvals
Develop the international regulatory strategy and contribute to Global regulatory plans
Support regulatory product compliance (e.g. RIM, PMCs, ESC levels, and agency commitments)
Support and advise on the local label strategy and alignment to cCDS/reference label
Build effective relationships and communication paths across global, regional, local and functional organizations
Enable efficiencies and seamless execution across the international countries
Contribute to process improvement projects, as assigned

Fulltime

Manager - International Regulatory Lead

The International Regulatory Lead (IRL) Manager will provide regulatory leadersh...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree OR 8 or more years of relevant regional regulatory experience
Master's degree and 9 or more years of relevant regional regulatory experience
Bachelor's degree and 10 or more years of relevant regional regulatory experience
Knowledge and experience in the international regulatory environment of clinical trial applications, non-clinical and/or clinical variations to marketing authorizations and product labelling relevant for biotechnology and/or oncology products
Comprehensive knowledge of regulatory principles and understanding of regulatory activities, and how they impact other projects and/or processes
General awareness of the registration procedures/challenges in International countries for Clinical Trial Applications, Marketing Applications and lifecycle management activities.

Job Responsibility

Advises Global teams on regulatory implications and requirements relevant to the global clinical development, Marketing Applications plans and objectives
Provides regulatory direction/expertise on the international regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, expedited regulatory designations, regulatory reliance mechanisms, compassionate use and pediatric plans)
Under general supervision, plans regulatory submissions (e.g. clinical trial, marketing authorization applications and lifecycle management) for products within Amgen's portfolio
Under general supervision, contributes to the development of international regulatory strategy documents (regulatory product filing plan, strategies, risks associated with the potential Agency outcomes and contingency planning, estimate likelihood of success) and communicates to others, as appropriate
Provides and maintains clinical trial and/or marketing application documentation (excluding Chemistry, Manufacturing & Controls documentation). May author documents/redact such documents to support a regulatory filing
Directs development of and manages the international label submission strategy, leads the negotiation activities with cross-functional teams and is accountable for the label deviation requests and outcomes
Supports local regulatory teams in triaging queries from health authorities, and where appropriate, helps identify existing responses to same or similar questions, leveraging knowledge management
Participates as a member of the Global Regulatory Team (GRT), and various global clinical and labelling focused teams
Shares regulatory information and implications with the GRT and other global teams on an ongoing basis and provides advice on international considerations
Partners with peers to agree on product strategy including projected submission and approval time

Information Systems Sr. Manager – Technology Regulatory Compliance Lead

Join Amgen's Mission of Serving Patients. At Amgen, if you feel like you're part...

Location

United States , Holly Springs

Salary:

135441.55 - 183244.45 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of Information Systems/Technology and/or Engineering experience OR Master's degree and 4 years of Information Systems/Technology and/or Engineering experience OR Bachelor's degree and 6 years of Information Systems/Technology and/or Engineering experience OR Associate's degree and 10 years of Information Systems/Technology and/or Engineering experience OR High school diploma / GED and 12 years of Information Systems/Technology and/or Engineering experience

Job Responsibility

Lead the development and execution of the strategy for computer system validation, regulatory compliance, and sustained inspection readiness for the Technology organization
Serve as the Technology Regulatory Inspection Lead, ensuring alignment with global quality and compliance strategies
Drive inspection readiness efforts, including playbooks, SME coaching, system documentation, and readiness dashboards
Oversee digital platform implementations, ensuring strong planning, resource management, risk mitigation, and financial oversight
Manage digital technology services, including validation, compliance, data integrity, and system reliability
Design and implement effective support models, including vendor and third-party management with clear accountability
Lead cross-functional teams, run key meetings, and present updates to senior leadership
Deliver technology solutions that improve efficiency, quality, and business alignment
Proactively manage complex, simultaneous projects and resolve challenges effectively
Establish performance metrics to drive continuous improvement

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
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

Manager, Early Development Regulatory Lead

This position represents one or more Regions / Countries on the Regulatory Sub t...

Location

Italy , Bologna

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Bachelor’s degree (minimum 5 years relevant experience) or advanced scientific degree (MS, PhD, Pharm D
minimum 3 years relevant experience) in regulatory affairs or pharmaceutical industry and/or clinical research
Experience supporting and/or leading IND/CTA submissions
Understanding of the cross functional drug development processes (Clinical Operations, Data Management, Biostats, and Regulatory)
Strong verbal and written communications skills
Excellent project and/or program management skills
Detail-oriented and ability to achieve results across functions and levels
Ability to work effectively across a highly complex, fast paced, matrix organization
Proficiency in MS Office Suite
Learning agility and 'scalability' to take on increasing responsibility as Intercept grows

Job Responsibility

Contribute to development and local/regional implementation of regulatory strategies for a low complexity program/single asset
Support planning, coordination, and preparation for meetings, including teleconferences with locoregional regulatory agencies
Contribute to regulatory review of study documents such as protocols, protocol amendments, ICFs, CSRs, IMPDs, IBs, and annual reports to ensure content and format meet all regulatory requirements
Contribute to development of regulatory submission plans
Assist with coordination and submission of locoregional IND/CTA submissions and maintenance activities
Support product development and lifecycle management activities
Support assessment of regulatory pathways for submissions to the FDA and other regulatory agencies
Manage multiple tasks in a fast-paced environment while keeping on task and to the company's quality standards
Drive the spirit of "ONE Team" across all functions by supporting a team approach to focus on our patients and customers as our top priorities

What we offer

competitive salary
comprehensive benefits
extensive opportunities for professional growth and development

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 Advertising & Promotion

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

7+ years of experience in Regulatory Affairs within the pharmaceutical, biotech, or medical device industry, with a strong emphasis on Advertising & Promotion
Deep and demonstrated knowledge of FDA regulations, guidance documents, and enforcement trends related to promotional activities
Proven ability to act as a strategic advisor and trusted partner to senior stakeholders
Extensive experience collaborating with Medical Affairs, Legal, and Commercial teams
Demonstrated ability to independently review promotional materials and make sound regulatory decisions
Strong experience in interpreting and applying FDA guidance to real-world scenarios, including the ability to adapt strategies accordingly
Excellent communication, influence, and stakeholder management skills
Strong critical thinking and problem-solving abilities, with a proactive and solutions-oriented mindset

Job Responsibility

Serve as a strategic regulatory partner to cross-functional stakeholders including Medical Affairs, Legal, Commercial, Marketing, and Clinical teams
Act as a trusted subject matter expert (SME) in FDA Advertising & Promotion regulations, providing high-level guidance on complex regulatory scenarios
Independently review and approve promotional and non-promotional materials, ensuring compliance with applicable FDA regulations, guidance, and industry standards (e.g., OPDP requirements)
Proactively interpret and apply FDA guidance, identifying risks and opportunities to inform sound regulatory strategy
Demonstrate the ability to pivot regulatory strategy based on evolving FDA expectations, enforcement trends, and business needs
Provide strategic input early in the development lifecycle, influencing messaging, claims, and communication strategy
Partner with Legal and Medical Affairs to ensure balanced, compliant, and scientifically accurate communications
Lead discussions on risk assessment and mitigation strategies, offering solutions-oriented recommendations
Support and, where needed, lead regulatory review committees (e.g., PRC/MLR), driving efficient and compliant review processes
Stay current with regulatory trends, FDA warning letters, and industry best practices, proactively sharing insights with internal stakeholders

What we offer

Flexibility of remote work

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

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Manager, Regulatory Lead

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