International Regulatory Lead Job at Amgen (Hyderabad)

Regulatory Change Management Lead

We are seeking a highly organized and experienced senior change business analyst...

Location

United Kingdom , Belfast

Salary:

Not provided

Citi

Expiration Date

Until further notice

Requirements

Significant financial services experience, with a focus on global markets trading and investment banking operations
Demonstrated knowledge of capital markets products, including cash securities, exchange-traded derivatives, and OTC derivative products
Demonstrated knowledge of one or more non-financial regulatory reporting regulations – CASS, DP, CFTC, SEC, CSA, CAT, EMIR, SFTR, MiFID II/MiFIR, etc.
Demonstrated experience in the successful implementation of projects, operational process change and improvement
Experience in working with cross-functional teams including business management, middle office, compliance, legal and technology
Experience in collecting, defining, and documenting business and technology requirements, test plans and other project management artifacts
Experience in consulting with project stakeholders, including the skills to facilitate compromises and resolve conflicting requirements
Strong consulting and stakeholder management skills and the ability to build and foster internal relationships
Knowledge and a technical understanding of securities processing including product, process and system knowledge
Strong analytical skills and the ability to collate and make sense of large amounts of data

Job Responsibility

Support the Change Management Lead in the direct management of multiple regulatory reporting projects, ensuring alignment with strategic objectives and regulatory requirements
provide guidance and mentorship to junior team members, fostering a collaborative and high-performance culture
work closely with business functions (e.g., Operations, Middle Office, Front Office, Technology, Compliance, Legal and Finance) to execute necessary policy, process, and technology change
liaise with Business Execution and Transformation teams on topics relating to program oversight, risk monitoring, financial and administrative reporting
support the governance of program/projects including facilitation of steering committee and working groups
identify key project risks, whether stated or not, and escalate accordingly
ensure that the delivery from the workstreams/projects meets requirements and is to the appropriate quality, on time and within budget

What we offer

Generous holiday allowance starting at 27 days plus bank holidays
increasing with tenure
a discretional annual performance-related bonus
private medical insurance packages to suit your personal circumstances
employee Assistance Program
Pension Plan
Paid Parental Leave
Special discounts for employees, family, and friends
Access to an array of learning and development resources

Fulltime

Business Performance Senior Manager

The Business Performance Senior Manager is a member of the Transformation Execut...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree (scientific area) and 10 years of directly related experience OR Bachelor’s degree (scientific area) and 12 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
Able to anticipate regulatory Agency questions and potential responses
Demonstrate strong teamwork ability

Job Responsibility

Represent GRAAS at cross-functional MAL and Business Development-related forums, providing strategic input and thought leadership
Form and lead sub-function teams for integration and licensing activities, ensuring alignment with strategic objectives
Drive strategic solutions to complex business problems, leading analyses and negotiations with key decision makers
Lead Regulatory workstreams across all deal phases
Serve as Lead for all product licensing work, including integrations into and transitions out of Amgen
Closely partner with Regulatory Affairs (RA) Therapeutic Area Integration Project Lead and advise/instruct them on end-to-end process and details of planning and execution of acquisition integration
Act as their delegate as needed in cross-functional meetings
Assist with pre-deal close GRAAS due diligence
Develop and manage GRAAS integration workplan
Draft and manage any new controlled documents unique to the integration, such as Quality Integration PLANs and bridging process GDEs

What we offer

Reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment

New

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, Regional Regulatory Strategist

As a Manager, Regional Regulatory Strategist, you will play a critical role in a...

Location

United Kingdom , London

Salary:

Not provided

Moderna

Expiration Date

Until further notice

Requirements

Degree in Life Science or related discipline, advanced degree preferred (PharmD, MSc, PhD)
5+ years of experience in the pharmaceutical industry. 3+ years of experience in Regulatory strategy
Strong experience with CTD format and content of regulatory filings
Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance in the EU and/or relevant International markets
Ability to work independently to manage multiple projects in a fast-paced environment
Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment
Outstanding communication skills (verbal and written)
A desire to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative

Job Responsibility

Supporting the development and execution of regulatory strategy for assigned programs in the EU and international markets in collaboration with Global Regulatory Leads, Regional Regulatory Strategists, and Country Regulatory Leads
Preparing and contributing to regulatory submissions including Scientific Advice meeting requests, briefing documents, clinical trial applications, orphan drug designations, pediatric plans, expedited pathway applications, DSURs, and marketing authorization applications (MAA)
Coordinating aspects of regulatory submissions relevant to the assigned program(s), ensuring alignment with global strategy and timelines
Supporting regulatory interactions with the EMA and other international health authorities
Engaging with cross-functional regulatory teams to ensure consistency, compliance, and strategy execution
Identifying, assessing, and managing regulatory risks associated with assigned program(s)
Tracking, following up, and archiving correspondence, regulatory commitments, and queries from EMA and international agencies
Working independently and collaboratively in matrixed project teams to achieve program goals
Applying critical thinking to anticipate potential regulatory hurdles and proactively address challenges specific to mRNA as a novel modality
Contributing to continuous improvement and innovation within regulatory processes

What we offer

Best-in-class healthcare, plus voluntary benefit programs
A holistic approach to well-being with access to fitness, mindfulness, and mental health support
Family building benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investments
Location-specific perks and extras

Fulltime