Offers “Gsk”

Expires soon Gsk

Regulatory Compliance Executive

  • Москва, Россия
  • Accounting / Management control

Job description

Site Name: Russia - Moscow
Posted Date: Dec 3 2021

Regulatory Compliance Executive

Job Purpose

Support Regulatory Compliance Manager activities at Regional Regulatory with focus on Regulatory Compliance, Training, and Regulatory Third party oversight.

Key Responsibilities

Work closely with a matrix of key stakeholders including Central RM team members, Regional Clusters/LOCs, Regional Regulatory and Central teams on supporting implementation of the Internal Control Framework (ICF) in LOCs and in the Regions. Ensure Regulatory oversight for regulatory service providers in the regions as applicable.

- ensure high quality collaboration between GRA, Regional and local Regulatory teams to have alignment of plans and work towards common business objectives;

- focus on Regulatory Compliance & Process Improvement, ensuring that Regional and local Regulatory practices and procedures are in line with global GSK standards, and to continuously examine and identify areas for improvement in the overall registration process to maximize process efficiency and deliver an improved service;

- participates in regional matrix project teams to provide regulatory advice and input into the regional/global regulatory plans or processes in the specified activity;

- contribute in Regional oversight of regulatory compliance process e.g. via participation in Regional Extended LT ICF in focus Meetings and in Area Extended LT ICF in focus meetings, as applicable. Perform regulatory compliance regional country visits and maintain appropriate independent MM tool to ensure regional oversight of regulatory compliance processes;

- provide support through escalation process to ensure that LOCs are able to obtain and provide timely responses to Health Authority questions as well as escalation of issues or risk that could affect the business;

- support the LOCs with readiness to for Independent Business Monitoring (IBM) and Audit and Assurance (AA) processes. Triggering annual MM cycle and ensure management monitoring plans for LOCs and Regional Regulatory teams in place and in use;

- support LOCs with efficient delivery on training and oversight activities including maintenance of regional training curricula (i.e. own LOC Training Curricula Gadget and ensure annual review, update as needed and communication changes for LOC Training Curricula (except ICF curricula), support preparation for LOC New Starter training, identify training needs of the team;

- support regulatory service providers oversight and partnership to LOCs for onsite assessment of regulatory service providers. Develop an oversight of 3P KPIs (creating the regional dashboard of 3P KPIs).

Requirements:

- degree (BSc) or equivalent in an appropriate bioscience (pharmacy, medical or related background);

- pharmaceutical Industry and regulatory affairs;

- job-related experience, preferably in a life science with 3+ years in regulatory affairs or relevant pharmaceutical industry experience;

- ability to coordinate and execute regulatory strategies for a given project/product;

- strategic thinker – ability to provide inputs into regulatory strategies and evaluate potential impact on overall project/product strategy;

- ability to identify and escalate issues and to propose mitigation strategies, maximize opportunities, with proven ability to develop collaborative relationships;

- ability to collaborate with other teams in the delivery of outputs in a timely manner;

- good presentation skills to ensure regulatory voice is clearly articulated and heard in the various cross functional teams;

- good influencing skills;

- experience with involvement in activities/ projects above country level;

- culturally aware;

- enterprise thinking with Quality mindset– needs to understand the constraints and drivers of other functions and the potential impact on RA, including how RA may facilitate in achieving the overall goal;

- analytical in thought; demonstrates attention to detail;

- fluent in English, with excellent writing skills.

Working location:  Flexible, depend on the offered candidate based.
Relocation to Moscow (Russia) is not expected 


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