Manager- International Regulatory Lead Job at Amgen (Hyderabad)

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

International Regulatory Lead

International Regulatory Affairs provides regulatory leadership/ expertise for t...

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
Knowledge of Regulatory principles
Working with policies, procedures and SOP’s
Comprehensive understanding of regulatory activities and how they impact other projects and/or processes
General knowledge of national legislation and regulations relating to medicinal products
General awareness of the registration procedures/challenges in the region for CTAs, MAs and all lifecycle management activities
Knowledge and experience in the international regulatory environment relevant for product area and development stage
Understanding of drug development

Job Responsibility

Provide regulatory leadership & expertise for International countries for one or more Amgen products
Collaborate with various functions and local regulatory teams
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

Senior Manager, International Regulatory Affairs

We are seeking a highly motivated, energetic professional capable of working eff...

Location

Japan , Tokyo

Salary:

Not provided

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

A bachelor of science degree in life science
Minimum of ten years of industry experience with at least six years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries, including good knowledge and understanding of the Japanese regulatory environment
Proven track record for preparing, submitting, and gaining approvals for JNDAs
Thorough understanding of relevant drug development regulations and guidelines
Outstanding interpersonal and communication (written and verbal) skills
Effective task planning and coordination abilities
Proficiency with computer and standard software programs
Fluent in English, both verbal and written (technical)
Strong collaborative skills
Good verbal, written and presentation skills

Job Responsibility

Develop Japanese Regulatory filing strategies and identify risks and potential gating factors
Lead the strategic planning and preparation of complex submissions including JNDA/JsNDA, post-marketing maintenance, re-examinations, JAN applications, expedited pathway applications
Ensure all submissions are prepared in accordance with Japanese regulations
Serve as primary liaison with the regulatory authorities (e.g., MHLW, PMDA) and interface on behalf of BioMarin to negotiate as needed
Lead in preparation for and execution of agency meetings
Actively participate in multi-functional global team environment, and interface closely with U.S. and other global BioMarin offices to align on operational and strategic deliverables
Evaluate new and emerging regulations/guidance to advise BioMarin on the Japanese Regulatory environment and changes that could impact BioMarin’s products or plans

Fulltime

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

Master's degree and atleast 8 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

Senior International Regulatory Affairs Lead

The Regulatory Affairs Lead provides expert telecoms and digital regulatory guid...

Location

United Kingdom , London

Salary:

Not provided

Vodafone

Expiration Date

Until further notice

Requirements

Expert knowledge of global telecoms, IoT, digital and data regulations
Strong understanding of global compliance frameworks
Proven ability to interact with senior stakeholders within the business as well as to lead international teams
Commercial acumen and ability to navigate complex international regulations
Adaptable and working effectively under pressure and in a dynamic environment
Qualified lawyer, economist, MBA or equivalent
Significant exposure to complex environments
Proven experience with leading a multidisciplinary team
>5 years experience in regulation and communications sector

Job Responsibility

Lead expert guidance on communications and adjacent sector-specific regulations impacting IoT and Vodafone Business global networks and connectivity services
Responsible for the delivery of telco regulatory compliance advice to the IoT and Business leadership and operational teams
Responsible for and management of international regulatory relationships: including obtaining and management of relevant licences and associated required reporting
Accountable for Group Regulatory Compliance Policy Framework

What we offer

Yearly bonus: 20%
Company car: company funded car of £580 per month + private fuel or cash alternative of £630 per month
Annual leave: 28 days + bank holidays + the opportunity to buy/sell/carry over 5 days/year
Charity days: 5 days/year
Maternity leave: 52 weeks: the first 13 weeks are fully paid, followed by 26 weeks of half pay
Private pension: You can contribute up to 5% of your basic pay with 2:1 matching from Vodafone up to 10%
Access to: private medical, private dental, free health assessments, share save scheme
Additional discounts: Vodafone retail, gym, cinema, cycle to work, season ticket loan

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- International Regulatory Lead

Job Description

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