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Regulatory Affairs / QA Director

Brazil · Full-time

About The Position

The Regulatory Affairs Director will be responsible for all regulatory activities in Brazil and Colombia, covering RA, PV and QA areas. He/she will take an active part of building the QMS and procedures to cover the relevant GxP activities in the territory. Will be in charge of developing, leading and managing all regulatory activities. S/He will also oversee all discussions and negotiations with local vendors and the health care authorities. The successful candidate will have the ability to thrive in an environment of rapid change; work effectively within cross-functional teams; will have a passion for highly innovative therapies that can dramatically improve patients' lives. Regulatory Affairs Director will be responsible to prepare/execute the development of comprehensive plans for preparation and submission of regulatory submissions. Provides independent tactical/scientifically related guidance cross functionally on aspects of regulatory affairs. Uses knowledge and experience in the regulatory field to influence functional objectives. Regulatory Affairs Director will be responsible to develop and implement SOPs in Brazil and Colombia, review, approve and monitor all GxP related activities and ensure proper training for the local employees. Serve as the Technical Officer to ANVISA and take regulatory responsibility for the products within the territory. Maintain a compliant and efficient Quality Management System, in accordance with local regulations and guidelines.

Oversee pharmacovigilance activities in the territory in accordance with applicable regulations.

Responsibilities

  • Create procedures (SOPs) for QA, RA and PV activities in the territory in compliance with Medison policies and the local regulations
  • Serve as the Technical officer (Responsible pharmacist) for products within Medison responsibility in the territory
  • Maintain the relevant expertise and knowledge of local regulations and requirement to ensure compliance of Medison regulatory affairs in the territory
  • Lead development and implementation of regulatory strategic plans, submission process and negotiations with ANVISA to deliver regulatory approvals in support of Business Unit objectives
  • Provide regulatory information/collaborate for development of the market access to align with products value proposition.
  • Train the staff in regulatory policies or procedures. · Establish regulatory priorities or budgets and allocate resources and workloads.
  • Maintain current knowledge of relevant regulations/policies/guidelines/initiatives.
  • Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
  • Routinely communicate with the Country Manager to directly ensure the regulatory requirements and planning is executed and adapt to align with the new business development targets and lifecycle phase of the product.
  • Represent the organization with senior level internal & external stakeholders
  • Maintain regulatory compliance of approved products.
  • Adhere to Good Regulatory Practice, ensure all regulatory submissions are compliance with local regulations.
  • Ensure Health Professional communications, public communications, promotional materials and press releases are aligned to corporate positions and policies, and compliant with regulatory requirements.
  • Develop and implement quality management policies and SOPs
  • Support global quality management in auditing and monitoring activities to ensure an effective quality management system
  • Develop and deliver training and education programs for all employees on quality management policies.
  • Create/conduct PV training programs to Medison employees (including new employees) and vendors and ensure maintenance of awareness of drug safety reporting in general.
  • Provide advice and guidance to local management and employees on regulatory related issues
  • Work with all relevant business areas to develop and implement corrective actions plans identified through quality management monitoring and auditing activities
  • Manage the QC laboratory and establish, maintain and execute batch release procedures
  • Establish and maintain local pharmacovigilance system and procedures covering all activities required by regulations and safety agreements with partners.
  • Hold responsibility for the pharmacovigilance knowledge and expertise in the territory
  • Serve as a local pharmacovigilance contact to the Partners and local Regulatory Authorities
  • Ensure compliance with the applicable Pharmacovigilance regulations and Medison corporate policies in the region
  • Oversight/Collect, review, perform quality check and forward of Adverse Events and other safety information obtained through various sources to MAHs; tracking and archiving AEs; performing reconciliation activities and documentation.
  • Perform local translations of ICRS, PSUR, RA correspondence, regulatory intelligence as required, and oversight the activity where translation service is outsourced.
  • Manage AEs related to Quality Complaints and Medical Information Queries.
  • Submit safety data to the local Regulatory Authority according to local regulations.
  • Oversight of data generating activities within the territory to ensure any solicitation of information includes an appropriate review and reporting process for reporting potential AEs (e.g., Patient support programs, market research surveys, internet sites etc.).
  • Safety oversight of clinical projects and pre-authorization access conducted in the territory.
  • Support in compilation of aggregate reports by providing requested data to partner.
  • Plan and ensure timely submission of Aggregate Reports according to local Regulations.
  • Perform/oversight local literature search.
  • Support and implement Business Continuity Plans (e.g., inspection readiness, AE reporting coverage). Ensure an effective system is in place for 24-h coverage and ensure that day-to-day PV functions are performed satisfactorily, and that optimal regulatory compliance is maintained.
  • Ensure and implement an appropriate PV and Risk Management in place in order to assure appropriate oversight for the implementation of Risk Management Activities for products within responsibility.
  • Oversight/be actively involved in localization and implementation of RMP and additional Risk Minimization Measures in collaboration with other departments, partners, vendors.
  • Ensure that new safety information is available to HCPs in a timely manner (Direct Healthcare Professional Communication) in compliance with local requirements and in cooperation with partner.
  • Stay up to date regarding the PV regulatory requirements in the territory and evaluate their impact on PV activities and responsibilities and take appropriate actions.
  • Perform review of SDEAs/PVAs with partners and vendors, maintain oversight to ensure safety reporting obligations are defined as necessary. Ensure implementation of the relevant activities in the country cluster under responsibility.
  • Ensure PV inspection readiness at all times, perform and undergo partners’ audits and regulatory inspections, address follow up actions from findings to non-PV staff and monitor corrective actions.
  • Participate in global meetings with partners if requested, provide technical and strategic input.
  • Create/conduct PV training programs to Medison employees (including new employees) and vendors and ensure maintenance of awareness of drug safety reporting in general.
  • Manage deviations and CAPAs.
  • Select, qualify, manage and oversight local vendors performing regulatory activities, including QA, RA and PV
  • Demonstrate effective communication, collaboration and leadership with all necessary stakeholders within and outside Medison to maximize ability to execute objectives in timely manner and with efficiency

Requirements

  • Minimum requirement: Bachelor’s Degree in Pharmacy
  • Additional requirements: strong background in Regulatory Affairs, Pharmacovigilance and Quality Assurance
  • A minimum of 6+ years pharmaceutical industry experience with at least 4-years in a PV responsibility role
  • A minimum of 4+ years pharmaceutical industry experience as a Technical Officer (responsible pharmacist)
  • A minimum of 2+ years pharmaceutical industry experience in Regulatory Affairs area
  • Experience in a large innovative healthcare organization preferred
  • Experience working with multinational staff organizations
  • Experience in managing and interfacing effectively with CEO Staff level stakeholders, negotiating and synthesizing messages
  • Experience in hands-on batch release activities
  • Excellent local and English language and overall communication skills
  • Strong problem solving and analytical skills
  • Ability to work in a highly dynamic and fast-growing organization with demonstrated capability to be at ease in a matrix structure with ability to influence