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Samba ChinnamSC

Samba Chinnam

Senior Regulatory Consultant

550 €/jour
Reading, GB
15 ans et +

Délai de réponse moyen : 1h

À propos de Samba

A regulatory professional with 16 + years of experience gained from different pharmaceutical companies, worked across clinical development to strategies. Also have strong management experience with a skill set of post marketing, lifecycle maintenance, labelling, CMC with EU, Swiss and ROW focused.
Key Skills
Project management, Oncology focused CTA submissions, lifecycle maintenance, new MA submissions, Project Orbis, PIP and orphan drug submissions, EAMs and strategies preparation, Mentoring and training, line management.

  • Anglais

    Bilingue ou natif

Accepte de travailler sur site
Reading (jusqu’à 50 km)

Expériences

  • Gilead UK
    Senior Manager Regulatory Affairs (Consultant)
    INDUSTRIE PHARMACEUTIQUE
    août 2024 - Aujourd'hui (1 an et 10 mois)
    Provide strategic and technical advice from development throughout the whole product lifecycle for all Oncology products. Prepare new strategies for product registrations and subsequent post-approval safety and indication updates. Work cross-functionally with a diverse number of stakeholders both internally and externally.
    • Responsible for supporting regulatory strategies and preparing submissions for designated products in the UK and IE region. These activities range from new product licenses to lifecycle activities and support all regulatory aspects of the application.
    • Prepare and maintain support to new MAAs and other post-licensing activities. Ensure that any updates to the Product Company Core Data Sheet (CCDS) are implemented in a timely manner in the impacted local market.
    • Support post-marketing activities for the preparation of regulatory submissions which may include variations, PSURs/RMPs, responses to questions, renewals, PIPs, and EAMs.
    • Works with Global and EU partners to fulfil the UK specific commitments and obligations for the new MAs and submit commitment applications in timely manner for conditional MAs.
    • Assist in ensuring product packaging and associated information is updated and maintained in accordance with product licenses in designated territories including the co-ordination of labelling translations as required.
    • Participate in RA team meetings, product team meetings and departmental meetings.
    • Use and update regulatory information systems for planning, preparing, tracking and storing submissions to regulatory agencies.

  • celegence
    Senior Regulatory Affairs Consultant
    janvier 2024 - juillet 2024 (6 mois)
    Support and provide guidance for leading the development, review and lifecycle management of international labelling of commercial products, development of CCDS, Target label profile (TLP) for new products. Act as inter phase for labelling submissions, maintain the labelling historical version with in the RIMs and support the labelling implementations as per the agreed timelines.
    • Responsible for preparation of core labelling strategies for the new product development across multiple markets and support product life cycle.
    • accountable for using and updating RA systems like Regulatory Information Management system (RIMS), Document or Content Management System and eCTD submissions
    • Manage activities in RIMS database under product life cycle management including Registration, Variations, Renewals and life cycle supporting submissions.
    • Ensure targets and compliance reporting requirements are achieved in accordance with established timelines for key deliverables
    • Work closely with the internal cross functional teams such as clinical, quality, safety and CMC for the labelling updates and support launch activities.
    • Support implementation of Regulatory Affairs systems as per Client or Partner projects
    • Work with artwork management system and QMS for the labelling implementation as per the agreed approval timelines and maintain the artwork history for tracking.
    • Lead/Contribute to implementation of Regulatory Information Management system / platform and associated data processes & data operations
  • Roche Products Ltd
    Lead Regulatory Consultant
    INDUSTRIE PHARMACEUTIQUE
    janvier 2022 - décembre 2023 (2 ans)
    Welwyn Garden City, Royaume-Uni
    Responsible for GB Oncology portfolio to translate the constantly evolving requirements of the UK Regulatory environment into Roche policies, procedures, solutions and strategies that ensure compliance and maximise the value for patients.
    • Maintaining of product lifecycle by submitting the EU approved variations to PLGB license including the CMC changes, CDS updates, HA recommendations, PRAC updates, etc. • Post marketing and life cycle management for CAP converted PLGB license and National license including ILAP application submissions and interaction with MHRA for submission strategy. • Preparation of new CTAs and amendments (substantial and non-substantial) submissions and co-ordination with EU partner for GB specific requirements. • Preparation of variations for the National licenses via European Commission Reliance Procedure for MA’s approved via centralised procedures. • Working on the new MA applications, orphan designations applications, PIP applications along with PIP modification and compliance checks as per the business needs. • Mentor and guide the new starters within the team and train them in line with the business requirements. • Preparation and submission of Early Access to Medicines Applications. • Closely work with EU partner to fulfil the GB specific commitments and obligations for the new MAs and submitting the renewal applications in timely manner for conditional MAs. • Submission of PSURs/PBRERS and updating of prescribing information for the promoted products as per the approvals and co-ordinate with medical, safety and commercial teams for promotional actives.
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Formations

  • Master of Science
    University of Hertfordshire
    2009
    M.Sc Molecular Biology Modules: Molecular biology, genes proteins & development and bioinformatics techniques.

Compétences (40)

Regulatory Strategy
CTA
MHRA co-ordination
RAMA XL
Lifecycle management
Post marketing
New MAAs
Onoclogy
Affiliate
Project Management
line management
CMC
Labelling
UK and EU
Orphan Designation Drug
PIP
PRAC
CCDS
PSUR/PBRER
Scientific meetings
EAMS (early access medicines)
UK/IE
import applications
Project Orbis
ILAP
Variations
Renewals
Obligations
commitments
artworks
country specific requirements
PIQ & BROMI
Article 61.3
line extensions
intralinks
Neuro Science
Gastro Interstine
• Maintaining of product lifecycle by submitting the EU approved variations to PLGB license including the CMC changes, CDS updates, HA recommendations, PRAC updates, etc. • Post marketing and life cycle management for CAP converted PLGB license and National license including ILAP application submissions and interaction with MHRA for submission strategy. • Preparation of new CTAs and amendments (substantial and non-substantial) submissions and co-ordination with EU partner for GB specific requirements. • Preparation of variations for the National licenses via European Commission Reliance Procedure for MA’s approved via centralised procedures. • Working on the new MA applications, orphan designations applications, PIP applications along with PIP modification and compliance checks as per the business needs. • Mentor and guide the new starters within the team and train them in line with the business requirements. • Preparation and submission of Early Access to Medicines Applications. • Closely work with EU partner to fulfil the GB specific commitments and obligations for the new MAs and submitting the renewal applications in timely manner for conditional MAs. • Submission of PSURs/PBRERS and updating of prescribing information for the promoted products as per the approvals and co-ordinate with medical, safety and commercial teams for promotional actives.
• Interact with the Health Authorities for Brexit related activities and provide strategic advice to the internal stakeholders. • Support the Brexit related activities, life cycle management for the CAP conversions for centrally authorised products and co-ordinate with the sub teams for product information updates for variations and renewal submissions. • Commitments, ensuring these are in alignment with regulatory requirements and agreed strategy and timelines. • Responsible for new MA submissions of marketing authorisation of oncology products, to register though Project Orbis route application including the ILAP applications. • Preparation and submission of new PIP applications and PIP modifications as per the business needs for the CAP converted products. • Work closely with the internal stakeholders and global team for the initial MA submissions, CMC and safety changes and proactively manage artwork, RMMs and pre-vetting of advertising and promotional materials. • Co-ordinate meetings with the Health authorities for the pre-submission and ILAP submission activities for new MA’s via project orbis. • Preparation of drug product information, in line with CCDS (PIL/SPC, labelling text documents and fragments) as per the health authority requirements. • Submission of urgent safety related submission in line with the outcome of PSUR or PBRER related assessments.
• Contribute to European effort, by participation in DRA Sub teams (UK, IE & MT), Centralized, DCP, MRP and National procedures, providing assistance to the GRA and CMC team. • Work closely with head of regulatory and local brand teams to ensure launch readiness plans are in place in order to successfully launch products. Proactive management of artwork, RMP commitments and pre-vetting of advertising and promotional materials. • Creation, submission and maintenance of official local drug information, including Patient Information Leaflets (PIL), SmPC, labelling and packaging texts documents • Work with global and local stakeholders to ensure optimization of MA submissions and their compliance with regulations and any other local requirements. Communication of any regulatory changes to the business units as necessary. • Provision of regulatory support for new strategic commercial opportunities. • Provide regulatory advice and support for divestment and in-licensing opportunities • Managing and submitting regulatory Clinical Trial Applications (CTA) activities for assigned clinical trials projects for Oncology for phase 1-III including the CR checks. • Where applicable, organize and participate in health authority scientific advice meetings with global teams to support product development programs. • Work closely with global and local colleagues to advise and agree on regulatory strategy, clinical development plans and data requirements for oncology products.

Catégories

  • Autre