International Regulatory Lead Job at Amgen (Hyderabad)

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

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

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 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

Finance Data Products - International Product Lead

The Data Governance Foundation Principal is a senior-level role responsible for ...

Location

Poland , Warsaw

Salary:

510000.00 PLN / Year

Citi

Expiration Date

Until further notice

Requirements

15+ years of experience in Data Governance, Data Management, or Process Engineering within Banking and Financial Services
Strong understanding of banking regulations, supervisory expectations, and differences in US/non-US reporting
Strong knowledge of Data Governance, Data Sources, and Data Insights, with proficiency in tools like glossaries and lineage
Demonstrated track record leading large, strategic, cross-functional data projects and change initiatives
Demonstrated leadership in operational management
Experience creating and executing frameworks to improve data quality and value for regulatory commitments and risk management
Wide knowledge base of financial products including Derivatives, Securities, and Credit Cards
Ability to work across a global organization to deliver on mandated reporting requirements
Excellent communication, influencing, and facilitation skills (oral, written, and presentation)
Balances a big-picture perspective with close attention to detail

Job Responsibility

Liaise with functions, lines of business and regional Federated Chief Data Office to understand and align Data Governance and/or Data Risk and Controls strategy related work
Develop approach and prioritization framework to define and track the prioritized scope for the enterprise data program
Integrate and align functions, lines of business, and regional data roadmaps into an enterprise data roadmap to deliver on the prioritized scope
Provide advisory services to functions, lines of business and regions on prioritization and requirements as needed
Analyze and identify overlapping initiatives to resolve duplication of effort
Partner with ECDO Function Heads to develop capability maturity framework
Develop materials to effectively and concisely articulate progress on the data governance strategy for senior leadership and regulatory updates
Liaise with metrics team to articulate clear requirements for objective measures necessary to support Data Governance storylines with key stakeholders

What we offer

Employer paid Defined Contribution Pension Plan contribution of 6% of employee’s pensionable earnings (PPE Program)
Employer paid Private Medical Care Package for employees and Private Medical Care Packages for certain family members available at preferential rates
Employer paid Life Insurance Program for employees and Life Insurance for certain family members available at preferential rates
Employee Assistance Program financed by Employer
Paid Parental Leave Program (maternity and paternity leave
statutory and 2 weeks additional paid paternity leave)
Sport Card for employees subsidized via Social Benefits Fund and Sport Cards for certain family members available at preferential rates
Additional benefits from Company’s Social Benefit Fund, in particular: Holidays Allowance, support for sport and cultural activities, team building events
Additional day off for volunteering
Cafeteria/ flex benefit – a company benefits system which enables employees to select and purchase benefits offered by a provider and available for employees on the platform

Fulltime

Service Line Lead – NAM Regulatory Development & Sciences

ProductLife Group is a global consulting and outsourcing partner to the life sci...

Location

United States

Salary:

200000.00 - 260000.00 USD / Year

Product Life Group

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a scientific discipline (life sciences, pharmacy, biology, chemistry, or related field)
Advanced scientific degree (PhD, PharmD, MD, or equivalent) preferred
20+ years of experience in regulatory affairs within the biotechnology and/or pharmaceutical industry
Demonstrated experience leading regulatory strategy and execution across early- and late-stage development through marketing authorization
Proven leadership experience in a consulting, professional services, or matrixed delivery environment
Extensive experience interacting with U.S. and ex‑U.S. Health Authorities and interpreting global regulatory frameworks
Deep expertise in global regulatory requirements, guidance, and legislation applicable to drug and biologic development
Ability to translate regulatory requirements into practical, executable development and submission strategies
Advanced understanding of regulatory submission strategy, Health Authority engagement, and regulatory risk management
Strong financial and operational acumen, including KPI management, forecasting, budgets, and utilization within consulting environments.

Job Responsibility

Own end-to-end performance and delivery of the Regulatory Development & Sciences Service Line
Drive service line KPIs including quality, timeliness, utilization, revenue, margin, and client satisfaction
Ensure consistent application of global standards, methodologies, SOPs, and quality requirements across all engagements
Act as senior escalation point for clients, balancing delivery quality, commercial objectives, and client expectations
Lead development and execution of global regulatory strategies across all stages of development, from pre‑IND to post‑marketing
Act as senior regulatory SME for complex and high‑impact programs
Serve as on‑demand Head / VP / Director of Regulatory Affairs for client organizations
Lead Health Authority interactions, including acting as Authorized Sponsor Representative when required
Provide strategic oversight and hands-on input into Health Authority meeting packages, special designation requests, and major regulatory submissions
Own financial and commercial management of the Service Line, including forecasting, budgeting, revenue planning, margin protection, and utilization

Fulltime

Regulatory Reporting Lead Analyst

The Regulatory Reporting role is an intermediate level position within the Contr...

Location

Hungary , Budapest

Salary:

14768850.00 - 24762350.00 HUF / Year

Citi

Expiration Date

Until further notice

Requirements

6-10+ years of extensive experience within the financial services industry and regulatory reporting
Good command of spoken and written English
Bachelor's/University degree in Finance, Accounting or related field
CPA or MBA preferred
Intermediate knowledge of U.S. regulatory reports such as FR Y-9C, FR Y-14, Call Report, FFIEC 009, FR Y-15 and others along with exposure to Basel III capital regulations, GAAP/SEC Reporting and stress testing frameworks like CCAR
Able to navigate through a large organization to streamline and summarize multiple information points and create repeatable processes to build consistency in presenting information
Exceptional oral and written communication skills, with ability to synthesize complex concepts, and influence change
Strong technical problem-solving skills and an ability to identify conflicts, discrepancies and other issues and bring together the right team to solution them
Ability to manage competing priorities and tasks in a complex and dynamic environment and work well as part of a team

Job Responsibility

Support the production, review and timely submission of regulatory filings and reports to U.S. regulators including reports such as FR Y-9C, FR Y-14, Call Report, FFIEC 009, FR Y-15 and others
Monitor and manage key metrics associated with reports to identify challenges and issues
Support implementation of processes and controls to mitigate the risk of inaccurate reporting
Collaborate with teams to resolve discrepancies
Support the team to drive process improvements to enhance the accuracy, efficiency, and transparency of the regulatory reporting process
Provide support for the team during regulatory inquiries and examinations, providing accurate information and analysis to support regulatory reviews
Partner with senior stakeholders across the firm, including Risk, Finance, Audit to provide updates on regulatory developments and impact assessments
Work with peers and program leaders on the implementation of U.S. regulatory changes within the reporting framework
Partner with Risk & Controls team to maintain and enhance an effective internal controls structure

What we offer

Cafeteria Program
Home Office Allowance (for colleagues working in hybrid work model)
Paid Parental Leave Program (maternity and paternity leave)
Private Medical Care Program and onsite medical rooms at our offices
Pension Plan Contribution to voluntary pension fund
Group Life Insurance
Employee Assistance Program
Access to a wide variety of learning and development programs, online course libraries and upskilling platforms, such as Udemy and Degreed
Flexible work arrangements to support you in managing work - life balance
Career progression opportunities across geographies and business lines

Fulltime

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International Regulatory Lead

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