Regulatory Affairs Specialist

Job Description Summary

Plan, coordinate, evaluate, follow-up, execute and implement pharmaceutical regulatory and technical activities, to obtain and maintain Marketing Authorizations (MA) of Sandoz products and ensure business continuity, in compliance with the goals set by the company and current local regulation in the markets of Central America and Caribbean (CAC).

Job Description

Main Responsibilities:

Regulatory intelligence and regulatory environment

• Understands the local and international regulatory environment and processes.

• Provides regulatory expertise and knowledge regarding local and international regulations.

• Follows up new legislation discussions with trade associations and Health Authorities (HAs).

• Monitors national changes in regulation by continuous education on regulatory issues and keeping up with – and communicating to other functions – changes and trends within the local and international regulatory environment which are likely to affect Sandoz’ interests.

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Operational excellence

• Works in team to prepare, execute, and define regulatory strategies for the registration of products.

• Provides technical evaluation of legal, technical, scientific, and clinical documents for dossier preparation.

• Compiles and prepares regulatory documentation for regulatory submissions with precision to support portfolio growth, effective launches, and business continuity.

• Responsible for regulatory maintenance activities, such as CMC changes, supply-limiting changes, safety label changes, MA renewals, and other related life-cycle management tasks.

• Prepares bioequivalence dossiers for submission to CAC HAs, as per local requirements, and follows-up the respective approval and maintenance processes.

• Liaises with HAs and analyses and prepares responses to the Letters of Authority Questions (LoAQ) during product registration and lifecycle.

• Tracks and communicates regulatory relevant activities and commitments, approvals, deadlines, events and KPIs for assigned products.

• Submits PSURs/RMPs and monitors compliance of related regulatory commitments.

 

Management of outsourced activities

• Manages and coordinates activities of outsourced regulatory agents, to ensure achievement of company objectives.

• Coordinates the control of expenses and approves/rejects invoices for expenses by dossier, payments to the Government and professional fees.

 

Support to other areas/functions

• Manages the discontinuation of product licenses for products that are to be pruned and actively and continuously engages in the portfolio optimization process.

• Reviews, approves and follows-up promotional and non-promotional materials in OneP3, to assure compliance with internal and external policies and regulations.

• Advises and provides educational input in regulatory affairs matters to the different business departments (i.e., Marketing, Quality, Supply, Finances, Medical) and keeps an assertive communication with them. 

• Coordinates artwork creation and the approval of artwork components.

• Ensures optimal launch preparations for new products in close collaboration with the DRA Lead, product management, launch management, local and global supply chain management (SCM) and quality assurance (QA).

• Provides technical support to tender processes and first batch control prior to launch.

• Provides full regulatory support to all functions and areas that require it, and involves the relevant line functions as appropriate.

 

Compliance

• Maintains country specific information in DRA-relevant databases and archives, in line with internal policies and SOPs.

• Ensures appropriate archiving of regulatory relevant documents, including correspondence.

• Contributes to the improvement of processes and participate in the creation of process descriptions, (i.e., local SOPs, working instructions, etc.) and with the onboarding process for new RA associates.

• Supports QA in ensuring that release of drug products is done in accordance with the registered information, and in accordance with local/international regulations.

• Provides support during audits.

• Ensures proper and timely handling of deviations and CAPA handling regarding RA related compliance issues.

• Attends trainings and meetings regarding the Annual Training Matrix and Compliance.

• Complies with Values & Behaviors and Company Policies.

 

Others

• Other responsibilities that the Lead of the department considers as appropriate for the position.

Main Key Performance Indicators

Achieve operational targets for Service, Cost, Net Working Capital and Collaboration:

• Submissions of new products

• Approvals of new Mas

• Maintenance of current MAs

• Launch Supply Availability

• Portfolio Optimization

• Adherence to SCM processes like S&OP, Planning parameter setting.
• Update of databases according to the established deadlines.
• Monthly reporting.
• Compliance with the deadlines to respond to the requests issued by HAs.
• Completion of all training sessions within the annual training plan, as appropriate.
• General business objectives related to: Sales, Costs, OpInc, Quality and Compliance.
• Comply with Values & Behaviors and Company Policies.

Required profile

• Education: University degree in Pharmacy
• Languages:  English and Spanish mandatory
• Experience:  3+ years in Regulatory Affairs within Pharma Industry

 

 Skills

• Team collaboration spirit

• Strategic and creative thinking 

• Results driven

• Negotiation skills

• Timeline and deadline management and planning

• Focus on internal and external costumers

• Project planning and management

• Occupational Knowledge

• MS Office Suite
• Regulatory Compliance

Skills Desired

Analytical Skill, Clinical Trials, Collaboration, Detail-Oriented, Lifesciences, Project Planning, Regulatory Compliance