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 general 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 (Pueblo Yaqui)
🏢 Sandoz México
📍 Pueblo Yaqui