Senior International Regulatory Affairs Lead Job at Vodafone (London)

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

Senior Regulatory Affairs Consultant - Regulatory Intelligence

As part of Parexel Consulting, you will play a vital role in helping biopharmace...

Location

United States , Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

At least 5-7 years of regulatory affairs experience to include previous regulatory intelligence experience
Knowledge of FDA regulations as well as an understanding of the Summary basis of approval and labeling is helpful
A minimum of a bachelor’s degree in a scientific or technical discipline, advanced degree preferred
Project management / leadership experience
Excellent interpersonal and intercultural communication skills, both written and verbal
Client-focused approach to work (Quality)
Results orientation
Teamwork and collaboration skills
Consulting skills
Critical thinking and problem-solving skills

Job Responsibility

Regularly search the public domain for new and updated regulations and regulatory guidance documents that can impact the client’s development programs, and report the most critical findings
Regularly search the public domain for competitor product regulatory developments and report the most critical findings
Inform client immediately of any changes to the regulatory environment directly affecting client’s business
Search for non-compliance letters or notices for client’s suppliers and provide a regular report
Perform ad hoc research on specific regulatory topics at client’s request, using the internet and various subscription database tools
Identify public commenting opportunities for draft guidances/regulations and coordinate review and comments from client. Lead the client’s internal process to obtain and coordinate SME impact assessments/comments, facilitate comment collection/assimilation, and help develop company messaging to share either with PhRMA working groups or directly with Health Authorities.
Maintain a list of upcoming regulatory meetings/workshops/conferences pertinent to client
Support Regulatory Intelligence activities, including the use of Cortellis, Citeline, WebWatcher. This includes tracking, coordinating and participating in ad hoc searches as well as scheduled activities.

What we offer

Flexible work arrangements
Opportunities for career growth
Supportive and inclusive environment
Diverse and global client exposure
Learn from experts

Senior Regulatory Affairs Associate

As part of Parexel Consulting, you will play a vital role in helping biopharmace...

Location

Peru

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Minimum 5+ years of professional experience in clinical trial regulatory affairs
Proven experience preparing and submitting clinical trial dossiers to the Ministry of Health (MOH) in Peru, including review of Annex 05 and completion of Annex 33
Demonstrated experience preparing and submitting clinical trial dossiers in other LATAM countries
Proficiency with Veeva Vault or similar document management system
Advanced written and spoken English proficiency
Strong regulatory strategy expertise in Peru and LATAM countries
Excellent verbal communication skills for presenting complex regulatory strategies to international clients
Client-focused approach with ability to understand and anticipate sponsor needs
Strong critical thinking and problem-solving abilities
Exceptional interpersonal and intercultural communication skills

Job Responsibility

Act as Local Regulatory Contact (LRC) and prepare and submit clinical trials through the REPEC Platform in Peru
Allocate 50% of daily time as Global Regulatory Lead for assigned global projects, providing strategic oversight and coordination
Prepare country-specific labels and review LATAM labels for regulatory compliance and consistency
Deliver verbal and written regulatory strategy communications to global sponsors, tailoring recommendations to country-specific requirements
Maintain and update the Trial Master File (TMF) in Veeva Vault with study documents and critical milestone dates
Keep project management tools current, including budget tracking and quality issue (QI) tools

Fulltime

Eu Regulatory Affairs Senior Manager (Biosimilars)

Location

United Kingdom , Uxbridge

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Degree educated in a scientific discipline
Extensive experience of the regional Biosimilars regulatory environment
Proven track record of developing and executing regional Biosimilars regulatory strategy
In-depth understanding of the drug life cycle and development process from a regulatory perspective
In-depth understanding of the registration procedures in region for MA, post approval changes, extensions and renewals
Ability to lead teams and work collaboratively in a dynamic environment
Proactive approach to problem solving
Ability to understand and communicate scientific/clinical information
Ability to anticipate regulatory agency expectations
Strong awareness of the needs of internal and external stakeholders, and the role of Regulatory Affairs in driving successful drug development

Job Responsibility

Plan and manage regulatory submissions for products within Amgen's biosimilar portfolio in compliance with global filing plans and local regulatory requirements
Implement product related regulatory strategies, Regulatory Affairs processes and activity planning
Lead development of regional regulatory documents and meetings in accordance with GRT strategy
Provide regulatory direction on regional regulatory mechanisms to optimize product development
Participate in the development and execution of regional regulatory product strategies, including precedence, risk management and contingency planning
Consistent with GRT strategy, advise on regulatory implications and requirements related to regional development plans and objectives
Lead Health Authority and Agency Interactions and document and communicate outcomes appropriately
Ensure and lead regulatory compliance for biosimilar products (eg, agency commitments)
Ensure all filings are maintained per regulatory requirements and consistent with biosimilar strategy throughout product development and long-term planning

What we offer

Growth opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Senior Regulatory Affairs Product Specialist

The Senior Regulatory Affairs Product Specialist serves as a key regulatory part...

Location

Poland , Warsaw

Salary:

Not provided

Theramex

Expiration Date

Until further notice

Requirements

Advanced experience with practical European Regulatory Affairs, including a good understanding of the following MA lifecycle activities within DCP, MRP and National procedures (preferably also other than URPL): post-authorisation variations impacting CMC, Safety and Product Information
different submission strategies (e.g. single, grouping, SuperGrouping, WorkSharing)
other RA activities such as renewals and PSURs/PSUSAs
CTD/eCTD documentation structure and lifecycle management
Knowledge and understanding of the following areas, European regulations and related guidance documents (e.g. management of documents, submissions, requirements): regulatory submissions across different markets and procedures, including the Centralised Procedure
Product Information authoring, editing and management
CMC documentation requirements
CTD and eCTD authoring, editing and lifecycle management
Able to perform other Regulatory Affairs activities with team support (e.g. PASS, PAMs, Centralised Procedure submissions)
Able to perform accompanying activities such as Artwork reviews/approvals and Prescribing Information preparation

Job Responsibility

Preparation and submission of required regulatory packages for designated products/countries, including variations and lifecycle activities
Authoring/updating of key regulatory documentation including CTD components and Product Information and leading review of other technical documents to ensure regulatory compliance
Development and implementation of regulatory strategy for required changes
Act as the contact within the business for regulatory advice and support related to designated products
Provide support and regulatory advice to key internal stakeholders including MS&T, Quality, Pharmacovigilance, Supply and other teams
Identification of any gaps in the regulatory documentation and conduction of any remediation necessary to achieve compliance
Communication with external stakeholders, including regulatory agencies, CMO's and third party service providers
Creation and maintenance of Regulatory Information Management systems and databases records and entries
Support of creation and maintenance of SOPs, working instructions describing regulatory and labelling processes and best practices to ensure compliance

What we offer

A fast-paced environment with broad exposure, giving you opportunities to develop professionally - even outside your core area of expertise
A culture that supports learning, celebrates success, and recognizes performance
Opportunities for driven and talented professionals to contribute to our exciting journey

Fulltime

Eu Regulatory Affairs Senior Manager - General Medicine

In this vital role you will work to ensure that Amgen acquires and maintains all...

Location

United Kingdom; Portugal , Cambridge; Lisbon

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Degree educated in a scientific discipline
Extensive experience in regional regulatory environment
Proven track record of developing and executing regional regulatory strategy
In-depth understanding of the drug life cycle and development process from a regulatory perspective
In-depth understanding of the registration procedures in region for MA, post approval changes, extensions and renewals
Ability to lead teams and work collaboratively in a dynamic environment
Proactive approach to problem solving
Ability to understand and communicate scientific/clinical information
Ability to anticipate regulatory agency expectations
Strong awareness of the needs of internal and external stakeholders, and the role of Regulatory Affairs in driving successful drug development

Job Responsibility

Plan and manage regulatory submissions (e.g. clinical trial and marketing applications) for products within Amgen's portfolio in compliance with global filing plans and local regulatory requirements
Implement product related regulatory strategies, Regulatory Affairs processes and activity planning
Lead development of regional regulatory documents and meetings in accordance with GRT strategy
Provide regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and paediatric plan)
Participate in the development and execution of regional regulatory product strategies, including precedence, risk management and contingency planning
Consistent with GRT strategy, advise on regulatory implications and requirements related to global clinical development plans and objectives
Lead Health Authority and Agency Interactions and document and communicate outcomes appropriately

What we offer

Growth opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
flexibility to work from home

Fulltime

Senior Regulatory Affairs Consultant

ProductLife Group (PLG) is a global life sciences consulting and outsourcing par...

Location

United States

Salary:

170000.00 - 210000.00 USD / Year

Product Life Group

Expiration Date

Until further notice

Requirements

Bachelor’s degree (BA/BS) in a relevant scientific discipline
10–15 years of Regulatory Affairs experience, with strong U.S. FDA exposure
Proven experience in independent development and execution of U.S. FDA regulatory strategies
Proven experience in authoring and leading INDs, NDAs, BLAs, amendments, and HA meeting packages
Proven experience in direct Health Authority interactions as Sponsor Representative
Strong working knowledge of FDA regulations and guidance
Strong working knowledge of ICH guidelines
Strong working knowledge of global regulatory frameworks
Demonstrated cross-functional regulatory leadership
Experience across multiple development stages (early development through registration)

Job Responsibility

Provide regulatory strategic and tactical leadership for biotech and pharma programs across development stages
Serve as Regulatory Lead / Advisor and project or program leader for multiple client engagements
Lead cross-functional teams (Clinical, CMC, Nonclinical) across multiple indications and product types
Develop and drive regulatory strategies, integrated development plans, and key regulatory documents
Coordinate, author, review, and manage Health Authority meeting packages
Coordinate, author, review, and manage special designation requests
Coordinate, author, review, and manage regulatory submissions (INDs, NDAs, BLAs, amendments)
Lead and represent clients in formal FDA interactions, including acting as Authorized Sponsor Representative
Lead and represent clients in formal FDA interactions, including preparing and coaching clients for Health Authority meetings
Interpret and apply FDA regulations, ICH guidelines, and global regulatory frameworks

Fulltime

Senior Regulatory Affairs Specialist

Cencora Pharmalex is one of the leading service providers for the Pharmaceutical...

Location

Belgium , Mechelen

Salary:

Not provided

Cunesoft

Expiration Date

Until further notice

Requirements

University degree in Life Science
Several years experience, or demonstrable capability, in area of responsibility or similar field
advanced knowledge and insights required to perform processes efficiently and proven potential to take over more complex tasks
Ability to deliver on customer or internal projects / processes within daily work
ability to prioritize parallel tasks, escalate issues where appropriate and to offer solutions for appropriate counter measures
Structured and systematic and independent way of working
limited latitude within established set of procedures, may determine priorities with little supervision
Ability to analyze and solve problems and to offer solutions for a given task or project. Attention to detail. High service orientation
Ability to train and support junior/new colleagues in daily activities
ability to lead small projects with clearly defined scope

Job Responsibility

Develop and maintain client relationships and highlight opportunities for increased service support to the respective lead
Participation in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products (applications, renewals, variations) including medical devices, cosmetics, food supplements and herbal products
Support with preparation, review and compilation of documents within the framework of regulatory affairs projects
Communicate with clients and Health Authorities in close cooperation with the respective lead
Support with the planning and execution of client projects in accordance with KPIs in close cooperation with the respective lead
General guidance (consultancy) of colleagues and clients regarding Regulatory Strategy and Procedure Management
Regulatory intelligence - develop and maintain personal regulatory knowledge, apply to client projects and actively share with colleagues
Support with strategy implementation and optimization
Comply with and support the maintenance of internal procedures
Provide operational insights to support with VDC led commercial, marketing and business development activities including proposal input in close cooperation with the respective lead

Fulltime

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Senior International Regulatory Affairs Lead

Job Description

Job Responsibility

Requirements

What we offer

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