Senior Manager, Central Regulatory Affairs Job at Baxter (Bangalore)

Regulatory Affairs Senior Officer

Reporting to the Head of Regulatory Filings, located in Jersey, you will be resp...

Location

Luxembourg , Luxembourg

Salary:

Not provided

Alter Domus

Expiration Date

Until further notice

Requirements

A minimum of 5 years of experience in Financial Services, with a minimum of 2 years in a Regulatory Compliance or Filings execution role
Solid technical knowledge and practical experience in operational regulatory compliance and filing requirements (not just strategic framework design)
Exceptional organizational skills and unwavering attention to detail are critical for register maintenance and filing accuracy
Proven track record of independently and accurately executing complex, repetitive compliance tasks and meeting strict deadlines
The ideal candidate must demonstrate a passion for continuous learning and professional development
Demonstrate clear, concise, and professional communication skills, especially in articulating data requirements and status updates to stakeholders
Strong practical analytical abilities to identify and resolve data discrepancies or filing issues quickly

Job Responsibility

Ensure the correct discharge of all regulatory processes, including all relevant regulatory notices, applications, and files
Execute the preparation, quality assurance and timely submission of regulatory filings, notices, and applications, ensuring all documentation is complete, accurate, and ready for review by the Head of Regulatory affairs (located in Jersey)
Assist the Head of Regulatory affairs in the maintenance of the centralized regulatory register, accurately tracking all incoming and outgoing regulatory notices, applications, and compliance activities
Ensure strict adherence to the global compliance framework developed by the Regulatory Affairs team, including following all defined processes, timelines, and reporting responsibilities
Maintain comprehensive, audit-ready files and supporting documentation for all regulatory submissions
Support the Regulatory Affairs team in implementing new processes, procedures, and systems related to regulatory filings and data management
Coordinate closely with internal stakeholders (Risk, Compliance, Legal, SMEs) to gather necessary data and sign-offs required for accurate regulatory submissions
Conduct internal checks and controls on submission data before final delivery to applicable sign-off

What we offer

Support for professional accreditations such as ACCA and study leave
Flexible arrangements, generous holidays, plus an additional day off for your birthday
Continuous mentoring along your career progression
Active sports, events and social committees across our offices
24/7 support available from our Employee Assistance Program
The opportunity to invest in our growth and success through our Employee Share Plan
Plus additional local benefits depending on your location

Fulltime

Regulatory Affairs Pharma

The Regulatory Affairs Specialist is responsible for providing procedural, admin...

Location

Belgium , Brussels

Salary:

Not provided

Amaris Consulting

Expiration Date

Until further notice

Requirements

University degree (or equivalent, e.g., A1 in Belgium), preferably in a scientific discipline related to medicine (e.g., Pharmacy, Life Sciences, Medicine, Biology, Chemistry)
4–6 years of experience in the pharmaceutical industry, with solid knowledge of the drug development and/or approval process
Proven experience in EU regulatory submissions (centralized and/or decentralized/MRP) and lifecycle management is a strong asset
Good command of English (written and spoken)

Job Responsibility

Provide administrative regulatory support during the filing and review of new submissions and variations to ensure compliance with EU requirements
Plan and coordinate new submissions, variations, CHMP referrals, and FUM to ensure timely submission
Draft Module 1 components and coordinate the collection and organization of all Module 1 documentation
Collaborate closely with Regulatory Operations to define submission timelines and Module 1 content
Work in close partnership with Country RA Registration Managers to secure timely submissions in all relevant markets
For centralized procedures, supervise and coordinate the translation process to ensure on‑time submission to EMA
Provide additional administrative support related to Marketing Authorization Applications to senior Regulatory Affairs staff (Executive Director, Distinguished Scientist, Senior Principal Scientist, Associate Principal Scientist, Senior Scientist) as needed
Ensure accurate and timely updates to regulatory databases and tracking tools
Stay current with EU procedural requirements, guidelines, and legislation, and apply them in daily activities
Participate as Subject Matter Expert (SME) in relevant workstreams and projects as assigned by Regulatory Affairs Europe senior leadership

What we offer

Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees
Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions
International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe

Fulltime

Regulatory Affairs Specialist

Regulatory Affairs - office based - Bogota. ICON plc is a world-leading healthca...

Location

Colombia , Bogota

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in Pharmaceutical Chemist or next to graduate required
Minimum 1 year of experience in regulatory area within the pharmaceutical or biotechnology industry
Knowledge or awareness of current regional guidelines and regulations is preferred
Technical knowledge in the preparation of a dossier is desirable
Prior experience using computerized information systems required: PC Windows, word processing and electronic spreadsheets
Advanced English level

Job Responsibility

Manage activities associated with obtaining initial, amendment and other central authority approvals i.e. Regulatory Agency (RA), and any other central authorities for the assigned country/ countries
Perform submission and maintenance of new health records, renovations and modifications to keep the products on the market according to the strategic plan established by the company, current Colombian laws and current local health legislation in accordance with the corporate guidelines and policies, procedures and premises
Review of promotional materials for products for human use of their therapeutic line(s) in Veeva Vault or current tool
Perform submission and monitoring of products for human use of their therapeutic line(s) in procedures such as: PSUR, DSUR, RMPs, and safety information according to current Colombian regulations
Back-up to the Head of Regulatory Affairs and analysts of records in the procedures of INVIMA in order to guarantee the operation of the area
Ensure that IP labels are in adherence to country requirements and submitted where applicable
Support the senior level regulatory staff/country consultant in the maintenance of accurate, up-to date Country Knowledge repositor
Contribute to the maintenance and collection of regulatory intelligence by ensuring that tools such as the Country Knowledge Repository and the Country Fact Sheets are up-to-date and communicate new information or changes to the Regulatory Intelligence Consultant team
Preparation of electronic regulatory submission of post-registration requests, HMPs, Labeling notifications, additions, publication corrections and database corrections, among other petitions to be field at MoH
Follow-up on the status of the regulatory submissions (paper dossiers) from dispatch to the receipt of proof of protocol

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

New

Senior Counsel (Regulatory)

Vocalink Limited is looking for a Senior Counsel (Regulatory) who will report to...

Location

United Kingdom , London

Salary:

Not provided

Mastercard

Expiration Date

Until further notice

Requirements

Qualified lawyer with mid-level experience, ideally including experience working in-house within a retail bank, regulated payments business, or central bank/relevant regulator
A strong understanding of Bank of England Financial Market Infrastructures and PSR regulations
Solid understanding of relevant UK payments regulation and the broader regulatory and policy landscape
Demonstrate the ability to influence internal stakeholders, regulators and policy makers
Excellent written and verbal communication skills, combined with an ability to communicate complex regulatory issues clearly and concisely business
Must demonstrate a proactive, time sensitive, results driven approach in carrying out all duties, obligations and responsibilities
Experience of operating within a multi-faceted organisation working closely with a variety of teams – compliance, legal, government affairs, product, etc
Self-starter / motivated to work independently and as an effective team member
A strong commercial awareness, risk-based approach and “yes, if” attitude to providing regulatory advice

Job Responsibility

Providing clear, business-focused advice on all applicable regulatory requirements, in line with the regulatory strategy, including in particular Bank of England Codes of Practice and Supervisory Statements, PSR regulations, and other laws/regulation applicable to Vocalink, its product, and its services
Monitoring and tracking regulatory developments relevant to Vocalink Limited and communicating these to internal stakeholders at all levels of senior management
Assessing the impact of regulatory developments on Vocalink, working with internal stakeholders to develop positioning, and drafting relevant consultation responses
Preparing concise written updates, training, and presentations on regulatory developments and their implications for Vocalink
In partnership with Compliance, supporting regulatory engagement, including the preparation of submissions, briefing materials, and related communications
In partnership with the wider regulatory team and other stakeholders, leading Vocalink’s engagement with the PSR/FCA
Representing Vocalink’s Legal team at governance forums, such as Vocalink’s Operational Resilience Form, Operating Committee, Executive Committee, Board, and their subcommittees
Managing external counsel on relevant regulatory matters
Being a key stakeholder and contributor to Vocalink’s overall regulatory and policy strategy
Providing regulatory support to the broader RTP and Network Products division where needed

Fulltime

Director, Strategic Enablement & Operations

The Director, Strategic Enablement serves as a key operational and thought partn...

Location

United States , Washington

Salary:

171000.00 - 285000.00 USD / Year

GSK

Expiration Date

Until further notice

Requirements

Bachelor's degree required
Minimum of 10 years of total working experience in any combination of pharmaceutical, biotechnology, healthcare, public affairs, communications, government affairs, or related disciplines
Experience supporting senior executives and leadership teams in highly matrixed organizations
Experience leading cross-functional strategic initiatives and operational improvement efforts
Experience managing complex projects with multiple stakeholders and competing priorities
Proven executive communication and presentation development experience
Ability to travel up to 20%

Job Responsibility

Serve as a key operational partner to the VP of U.S. Communications & Government Affairs
Drive alignment and connectivity across US CGA and other relevant USC functions
Lead execution of near, medium, and long-term projects and strategic initiatives across the US CGA function
Partner with functional leaders to translate enterprise and business priorities into coordinated functional strategies and execution plans
Identify opportunities to improve collaboration, decision-making, information flow, and organizational effectiveness
Lead execution of cross-functional strategic initiatives and special projects
Establish and manage core business rhythms, including leadership team meetings, strategic planning processes, annual goal setting, budget coordination, and operating reviews
Build scalable operational processes, governance models, and reporting mechanisms
Oversee tracking of strategic priorities, milestones, risks, and action items
Develop dashboards, metrics, and performance reporting

What we offer

Competitive base salary
Annual bonus based on company performance
Flexible working options available for most roles
Learning and career development
Access to healthcare & wellbeing programmes
Employee recognition programmes
Health care and other insurance benefits (for employee and family)
Retirement benefits
Paid holidays
Vacation

Fulltime

Senior Biocompatibility & Toxicological Expert

At Fresenius Medical Care, we are the global leader in kidney care, committed to...

Location

Germany , Bad Homburg

Salary:

Not provided

FMS USA Fresenius Mgmt Services Inc

Expiration Date

Until further notice

Requirements

Successfully completed master's degree in toxicology, chemistry, physics, life sciences, engineering, or a related field
Related working experience: 2–8 years, depending on level (Expert / Senior Expert)
Solid expertise in biocompatibility evaluation and toxicological risk assessment
Experience in project management or cross-functional coordination
Strong knowledge of medical device regulations and standards (e.g. MDR 2017/745, ISO 13485, ISO 14971, ISO 10993 series, FDA 21 CFR Part 820)
Good understanding of global quality management systems and regulatory environments
Strong analytical skills, structured working style, and experience in scientific writing
knowledge of statistical methods is a plus
Ability to work independently and lead cross-functional topics without direct disciplinary authority
Proactive, solution-oriented mindset with strong organizational and communication skills

Job Responsibility

Lead biocompatibility and toxicology activities for a global medical device platform, including active devices and disposables
Define and drive the overall strategy for biological safety and toxicological evaluation across the product lifecycle
Take end-to-end accountability for key deliverables (e.g. biological evaluation plans/reports, toxicological risk assessments) in alignment with internal experts
Act as the central interface for cross-functional stakeholders, aligning requirements and prioritizing activities
Ensure compliant safety and risk assessments based on materials, extractables & leachables, and biocompatibility studies (ISO 10993)
Provide expert guidance and scientific assessments to support product development and regulatory submissions
Coordinate global biocompatibility activities and collaborate with internal competence centers, EHS, and Quality & Regulatory teams
Contribute to design control, regulatory compliance, and continuous improvement initiatives, including sustainability aspects

What we offer

Individual opportunities for self-determined career planning and professional development
A corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest one
A large number of committed people with a wide range of skills, talents and experience
The benefits of a successful global corporation with the collegial culture of a medium-sized company

Fulltime

Senior Director, Enterprise Stakeholder Engagement

The Senior Director of Enterprise Stakeholder Engagement will lead PepsiCo’s ent...

Location

United States , Purchase, New York; Washington, District of Columbia

Salary:

157200.00 - 312000.00 USD / Year

Pepsico

Expiration Date

Until further notice

Requirements

10+ years of experience in public policy, government affairs, regulatory affairs, external relations, risk management, or a related field
Proficiency with statistical tools and data platforms (e.g., advanced Excel modeling, R, Python, SQL, or similar analytics software)
Strong quantitative, analytical, and statistical capabilities, with demonstrated experience applying data-driven methods to assess and model organizational risk
Demonstrated experience operating in politically sensitive or high-risk external environments
Strong judgment and ability to assess ambiguous or complex stakeholder dynamics
Experience advising and influencing senior executives
Proven ability to work cross-functionally and navigate complex, matrixed organizational structures

Job Responsibility

Own and evolve PepsiCo’s enterprise stakeholder engagement framework, including stakeholder mapping, prioritization, and governance processes
Maintain a centralized, enterprise-wide view of external stakeholders to enable visibility, coordination, and strategic alignment
Apply consistent, enterprise-wide criteria to assess stakeholder relevance, influence, risk exposure, and strategic alignment
Ensure stakeholder engagement and funding decisions reflect enterprise priorities and reinforce PepsiCo’s broader external strategy
Lead structured review and alignment processes for enterprise-level stakeholder engagement decisions, ensuring transparency, consistency, and accountability
Design dashboards, models, and decision support systems that inform enterprise strategy and stakeholder management
Conduct quantitative risk assessment, probability modeling, scenario analysis, forecasting, and development of risk metrics, indices, and scoring frameworks that translate uncertainty into actionable insights
Integrate quantitative findings into governance and stakeholder engagement strategies, linking risk exposure to operational, reputational, regulatory, and social impact considerations
Use data-driven methodologies to help the enterprise anticipate emerging stakeholder trends, external pressures, and evolving expectations
Serve as a trusted advisor to senior leaders on external stakeholder engagement strategy

What we offer

Bonus based on performance and eligibility target payout is 35% of annual salary paid out annually and an additional target payout of 15% of annual salary is paid out over 3 years following the end of the performance period
Long term incentive equity may be awarded based on eligibility and performance
Paid time off subject to eligibility, including paid parental leave, vacation, sick, and bereavement
Medical, Dental, Vision, Disability, Health, and Dependent Care Reimbursement Accounts, Employee Assistance Program (EAP), Insurance (Accident, Group Legal, Life), Defined Contribution Retirement Plan
Car allowance

Fulltime

Head of Public Policy

As Head of Public Policy (UK & Ireland) you will report to the General Manager -...

Location

United Kingdom , London

Salary:

Not provided

Voi Technology

Expiration Date

Until further notice

Requirements

Bachelor degree in Law, Political Science, Public Policy, Business, Economics, Communications or similar
Professional fluency in English
Experience in public affairs within mobility, transport, tech or other policy-driven sectors
Strong understanding of the UK political environment and experience influencing regulatory and political processes
Ability to use data and evidence in policy development and advocacy
Skilled in drafting regulatory positions, consultation responses and policymaker-facing arguments
Experience leading complex cross-functional work with local and central stakeholders
Experience managing direct reports and developing teams
Experience from using AI in a specialised, role specific way, and adapt workflows

Job Responsibility

Developing and implementing the UK policy strategy in collaboration with the UK GM, the local team and other central stakeholders
Leading policy development work by outlining regulatory positions, interpreting new rules and producing clear material to support engagement in the UK and Ireland
Working with Analytics and Product teams to strengthen Voi’s evidence base and advocacy positions
Identifying, monitoring and preparing for tenders across the region, ensuring the right policy positioning
Engage proactively with city and regional authorities to shape upcoming mobility tenders and secure opportunities for participation
Collaborating with Product, Operations, Legal, and Tender team to align regulatory positions and support readiness for upcoming rules
Accountability for our public relations including setting strategic direction with our PR agency
Driving proactive PR to drive media stories to help us achieve our policy and commercial objectives
Owning and developing senior political, technical and administrative relationships across the UK & Ireland, ensuring early insight into regulatory developments
Representing Voi in consultations, conferences and working groups ensuring consistent and professional presentation of Voi’s positions

What we offer

Get “skin in the game” through our employee stock options program

Fulltime

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Senior Manager, Central Regulatory Affairs

Job Description

Job Responsibility

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