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.
- undefined

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.
- undefined

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 integral 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

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📌 Regulatory Affairs Specialist (Insurgentes de Pueblo Yaqui)
🏢 Sandoz México
📍 Insurgentes de Pueblo Yaqui