Portfolio Strategy & Optimization Director

Job Overview

Planning Area
QUEENSTOWN
Job Type
Permanent
Salary
$10,001 - $20,000 Per Month
Date Posted
14 days ago
Expiry Date
14-Oct-2022

Additional Details

Job ID
413252
Job Views
53

Job Description

Roles & Responsibilities

Job Description

Job Purpose

As the Portfolio Strategy & Optimization Director, you will be reporting to the VP Regional Regulatory Head, Greater China & Intercontinental. You will have the overall responsibilities below:

  • Development (regional input) and implementation of business-focused, high-quality, timely regulatory strategy to support market regulatory approval of medicines and vaccines, line extensions, new indications and post-approval activities across Region in alignment with GRA objectives, regional commercial strategies and priorities
  • Prioritisation of regulatory post-approval activities across Region based on commercial expectations and priorities, aiming to achieve an efficient and effective license maintenance process that could help to optimise the portfolio for the whole region, and committed to ensure compliance for authorised licences with their actual manufacturing specifications and label updates
  • Close collaboration and alignment with GRA and regional cross-functional leads to support business development opportunities
  • Support to Local Operating Company Regulatory Affairs (LOC RA) in Region with the ultimate goal to achieve the cross-regional alignment and regional objectives

Responsibilities

  • Represent Regulatory function in collaboration with regional stakeholders, fostering total alignment with the regional team on regional strategies and priorities and emerging business opportunities and contributing to the decision-making process
  • Collaborate with GRA and LOC RA in development of regulatory strategies to advise on specific local regulatory requirements and their implementation in the global strategy for effective planning (e.g. submission prioritisation based on regulatory requirements and commercial opportunities etc)
  • Act as the regional liaison in interactions between GRA and LOC RA to:Ensure that LOC RA input for portfolio strategy planning is provided on a timely basis
    Contribute to development and implementation of regional regulatory strategies to support successful launch excellence, including collaboration with GRA in setting the strategy, following up with the global regulatory milestones to ensure alignment with business priorities and embed specific regulatory needs (such as GMP inspections, clinical trials etc)
    Support and monitor timely execution of regulatory submission plans, timely responses to questions to achieve launch excellence in collaboration with GRA and LOCs
    Support successful implementation of post-approval regulatory strategies, including collaboration with global oversight teams to ensure regional business priorities are incorporated into the global regulatory strategies
  • Anticipate and escalate risks and issues related to global portfolio regulatory strategy, supply disruption and post-approval activities in Region
  • Engage in timely manner with GRA, LOC RA and regional cross-functional teams to support risk mitigation and issue resolution
  • Represent Regional Regulatory function in global forums and cross-functional collaboration to advocate regional commercial position and address region-specific issues. Provide regional support to GRA in global initiatives
  • Interpret new regulations and liaises with Regulatory Policy and Intelligence team to raise awareness for impact evaluation of emerging and/or changing regulations. Identify possible risks and develop regional mitigation strategies at early stage based on available experience and expertise. Understand, interpret and advise on processes & guidelines and their implementation / use at local level
  • Act as an advisor in business development opportunities providing regulatory input at earliest stages of the deals and supporting Due Diligence as appropriate
  • Lead regional initiatives
  • Maintain oversight and provide guidance on E2E Portfolio Strategy and Portfolio Optimisation activities. Oversee performance and compliance of applicable KPIs and engage with GRA and LOC RA as required
  • Act as an SME in established processes. Provide regional view and input on development / revision of global and regional processes. Identify possible opportunities of process improvement / simplification / harmonisation cross-regionally. Develop the appropriate solutions for unmet needs or region-specific requirements and discuss them with global / regional teams

Why you?

Basic Qualifications

We are looking for professionals with these required skills to achieve our goals:

  • Degree in scientific discipline (Life Sciences / Pharmacy or equivalent)
  • Relevant Pharma industry experience in Regulatory Affairs of which a considerable part has been in a senior role in multinational companies
  • Experience in managing large market / above country regulatory functions
  • Experience of leading diverse multi-cultural teams
  • Experience of working effectively in a matrix across functions

Preferred Qualifications
If you have the following characteristics, it would be a plus:

  • Master or PhD in scientific discipline (Life Sciences / Pharmacy or equivalent)
  • Local ground operations background is an added advantage

Location

23 ROCHESTER PARK 139234 SINGAPORE

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