• Regulatory Affairs Lead Jobs in Jeddah - 1603051

    Pfizer Inc.
  • 6 - 9 Years
  • Jeddah (Jeddah)
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Job Description

Position Purpose

The PCO based Regulatory Lead for a country or a cluster will lead, manage and provide strategic direction and oversight to the Country based regulatory teams or cluster markets that give support to develop and execute regulatory strategies and plans for the country (ies) and region, where applicable The PCO based Regulatory Lead would represent Regulatory on the Country Manager Forum and local Country Medical Council (or equivalent) to ensure collaborative connectivity with these key stakeholders (eg Commercial, Medical, etc), and a more focused regulatory approach to supporting country business objectives

Primary Responsibilities

Lead and manage the RA team (if applicable) under their responsibility in the development of regulatory strategies to support the registration of clinical trial applications, new products, line extensions, major variations and lifecycle management Ensure that RA team under their responsibility provides strategic regulatory input into global regulatory strategies, thus providing optimal support for meeting local business objectives
Develop strong partnerships with in-country or cluster markets that give support (eg Country Managers, Medical, Marketing, Supply Chain), Regulatory regional teams and above country Therapeutic Area and Global Teams to facilitate the development and implementation of registration strategies to expedite the registration of new products, line extensions and life-cycle optimization
Provide strategic contribution to the country (PCO) or cluster markets that give support leadership team anticipate what Regulatory needs to contribute to achieve business objectives
Responsible for the development, leadership and performance management of the RA team to achieve company objectives Develop and enhance the capabilities and capacities of the RA teams through the identification and implementation of training and development needs
Responsible for developing and enhancing relationships with key external agencies (HAsBoH, RKOLs, etc) Manage the HABoH interface throughout the development and lifecycle of a product, developing a long-term and positive relationship characterized by Integrity, Quality, Compliance and Leadership Face before the MOH authorities
Active participation in trade organization of countries of responsibility and effective communication to key stakeholders of key issues that could impact regulatory strategies or the business Understand local regulations and developing trends in the local regulatory environment of the countries that support and provide assessment of the impact to key stakeholders Leverage regulatory intelligence landscape knowledge to support the development and implementation of regulatory and business strategies, and decision making Influence on new sanitary legislation initiatives that could impact the business
Maintain licenses (eg Marketing Authorizations) in compliance with local regulations of the countries that give support by ensuring that corporate regulatory processes, SOPs and systems (eg CMC change control, product labelling, etc) are in place, and is properly trained in these systems and procedures
Oversee and manage the completion of CTA, NDA and Lifecycle (LC) submissions and approvals as per established Regulatory performance metrics
Responsible for assuring GMP Compliance according to current Country regulations, where applicable

Technical Skill Requirements

Knowledge of the Regional and Global regulatory environment and how this impacts regulatory strategy and implementation
Knowledge of drug development practice, rules, regulations and guidelines
Communication skills
Negotiation skills
Problem Solving
Understands Business and Financial Environment
Understands Pharmaceutical Industry
Understanding stakeholder needs
Network and alliance building peer relationships
Team working
Interpersonal acumen
Organizational agility
Strong quality and compliance orientation
Analytical Thinking
Leadership and Management
Talent Development

Qualifications (ie, preferred education, experience, attributes)

Saudi Nationals
BS in Pharmacy
Extensive experience in Regulatory Affairs ( minimum 6 years) Proven ability to manage complex regulatory issues
Management Degree (Diploma or MBA) may be an advantage
Demonstrable experience across the Drug, Discovery, Development and commercialization lifecycle, with proven examples of contribution
Proven ability to consistently deliver to time, cost and quality standards
General management experience and previous line management and leadership experience at senior management level is essential
Demonstrable experience of effective delivery in a complex matrix environment

Organizational Relationship(s) including to whom the position reports

Direct Report to Head of Regulatory Affairs GCC I&I
Member and strategic contributor to the Country Medical Council and other PCO based teams (new product planning teams, etc
Member and strategic contributor to the Regional PEH RA Leadership Team

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates

Profile Summary

Type:Company Job

Role:Regulatory Affairs

Industry:Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial

Salary:As per Industry Standards

Function:Doctors/Nurses/Medical Professional

Deadline:25th Jan 2020

Company Profile

Company:Pfizer Inc.
Website http://www.pfizer.com/home/
Industry Healthcare (Pharmaceuticals, Biopharmaceuticals, Bulk Drugs)
Company Turnover 10000 - 10000+ Crores
Company Size 10001 - 10001+ Employees

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