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 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

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

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

Regulatory Manager

A newly created opportunity for a Chemical Regulatory Professional at a global c...

Location

United Kingdom , Northern UK

Salary:

Not provided

VRS Regulatory

Expiration Date

Until further notice

Requirements

Strong CLP knowledge
Experience with SAP EHS or similar regulatory systems would be advantageous
Team management experience preferred but not essential
desire to manage is essential
Confident and personable communicator
Proactive, solutions-focused mindset
Passion for continuous improvement

Job Responsibility

Leading chemical regulatory compliance across the EMEA region
Monitoring regulatory developments, assessing their impact and translating them into clear business actions
Providing expert regulatory guidance to internal stakeholders and customers
Representing the business within industry groups and external regulatory forums
Managing and developing a team of Product Safety Advisors
Driving improvements to regulatory systems, processes and compliance frameworks

What we offer

Pension contribution of 17%
Excellent benefits (as mentioned)

Fulltime

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Manager - International Regulatory Lead

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