Job Purpose Statement:
To translate the Pharma (Rx) business objectives into an actionable regulatory affairs strategy so as to ensure that our standards in respect to regulatory conformance and business continuity are maintained.
To add value to business by ensuring timely submissions and approvals for new products in WCA markets as well as maintenance of registered licences in alignment with local regulations and corporate.
Ensure Regulatory compliance by support and compliance to the QMS system
Essential Job Responsibilities:
Development and coordination of regulatory strategies with the support of the Head of Regulatory for regulatory submissions in WCA and collaboration with the HRA to simplify and improve existing regulatory processes, systems and techniques for the markets supported, to achieve the business objectives.
Ensure timely submissions and approvals of applications according to regulatory plan and strategy, ensuring continuity of supply and regulatory compliance.
Management of Regulatory projects to support new initiatives as appropriate to the business.
Ensure alignment of the regulatory registration submission strategy to commercial strategies and work effectively with key stakeholders and 3rd party service providers.to achieve the desired regulatory outcomes.
Liaise with Regulatory Authorities and provide appropriate answers on matters relating to Regulatory approvals/queries for our Products.
Ensure alignment of registered details with original dossiers and corporate databases, maintenance of and compliance with Regulatory Databases (OPAL, REQUIRE, GRACE)
Support the artwork control process to ensure changes and approval are done in time to avoid product stock out or delays in supplies.
Management of tender activities in relevant markets (as applicable)
Monitor and keep in touch with changes in the regulatory environments. Provide intelligence to local stakeholders and central team on changes in regulatory environment in the region.
Working with industry associations to strategically position our values and address any issues that would affect the business.
Support and ensure compliance to the QMS/QRM processes within Regulatory (written standard maintenance/compliance, regulatory issue management, risk management, management monitoring (L1 Audit), deviation handling, CAPA management, training, 3P oversight). Provide regulatory support to GMP inspections as required.
Competencies: (Expertise and Knowledge)
Knowledge & Application
The level of technical knowledge required for the role is applied for assessment of the regulatory files, submission of right first-time dossiers to Regulatory Authorities, communication with global and local stakeholders.
Examples:
Preparation of registration dossier according to local regulations
Preparation of SmPC and PIL and coordination of their drafts with global and local stakeholders
Communication with Authorities (submission of official requests, providing answers for Authorities’ request)
Communication with regulatory third-party service providers to ensure the company objectives are met
Problem Solving and Innovation
Works across multiple markets in complex regulatory environment with high unpredictability of regulatory decisions, not yet fully established regulations (evolving in maturity), lack of transparency and dialogue with Regulatory Authorities, different interpretation and application of regulations/guidelines.
Works in one of the most critical areas in terms of compliance to ensure:
Patients have access to products with minimal possible interruption of supplies because of changing regulatory requirements and
Supplied products are compliant with registered details, so there is no risk for patients’ safety or our reputation;
Risk of mistakes in products information is managed properly to minimize impact of regulatory related mistakes on business.
Works in one of fast-changing areas where changes are caused by external factors (regulatory requirements and practices), business needs to be aligned for each single country and in line with central procedures of compliance and product improvements. Needs to have the ability to make evaluative judgement.
Works through local regulatory service providers to provide the regulatory support required in market (i.e. appointments, submissions, follow up, response to queries, regulatory intelligence & advocacy)
Interaction
The role involves interaction with multiple stakeholders internally and externally and requires excellent communication, collaboration and negotiation skills:
Internally
Country level: LOCs Quality, Medical, Logistics and Distribution, Legal, Commercial
Regional: Regional Regulatory Affairs
Global level: Global Regulatory Affairs, GMS
Externally
Regulatory Authorities
3rd party service providers
Pharmaceutical Trade Associations
The communication needs to be clear, specific and consistent across all stakeholders both internal and external. It needs to be adapted to manage the diversity, harness the commitment & contribution of stakeholders internally and externally and collaborative to deliver the goal for the organization.
Multi-Cultural Awareness
The role involves interacting with multiple countries with racial/ethnic diversity as well as variance in socio-economic environment.
These factors need to be considered while working on regulatory strategy as well as interacting with internal and external stakeholders since alignment with the country’s and state authorities’ vision is essential for regulatory strategy or advocacy initiatives to be successful.
Therefore, the role holder should have the:
Ability to write and speak in English and French: Intermediate/upper-intermediate level;
Ability to work within diverse cultures and differing levels of organizational maturity;
High degree of comfort and positive engagement working as a member of a multifunctional and multicultural team
Constant search for Innovation, contributing with passion, and performance achieved with Integrity
Ability for multitasking, quick adaptation, agility and ability to make decisions/influence outcomes that include assessment of the potential impact, attention to detail.
Impact
Impacts business targets ensuring all new submissions, regulatory variations and renewals are agreed with logistics, commercial teams and in the countries, so they have minimal impact on supplies.
Influences on continuous product supply by ensuring alignment of registered details with original dossiers in multiple countries in WCA (as assigned) and working through third party service providers to achieve desired outcomes as per plan.
Impact on compliance (in complex/dynamic regulatory environment) ensuring that the standards of governance and oversight are applied, and that risks and issues are appropriately managed
Basic Requirements:
Bachelor’s Degree. Pharmacy or appropriate scientific degree
Minimum 3 years Regulatory Experience in the industry. Good working knowledge of regulations, current industry practices, and experience with seeking out, interpretation and application of regulatory guidance.
Excellent communication influencing and negotiation skills
Masters or PhD (would be an added advantage)
Qualification in project management (would be an added advantage)
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