Regional Regulatory Lead - Johannesburg, South Africa - JorDan Human Resources

JorDan Human Resources

Verified Company

Johannesburg, South Africa

2 weeks ago

Posted by:

Thabo Mthembu

beBee Recruiter

Description

Permanent

JHB006835

Medical, Pharmaceutical & Nursing

Gauteng, JHB - Eastern Suburbs
R R Annually Basic Salary

Leading Pharmaceutical Company on East Rand seeking Regional Regulatory Lead to join their team
Provide oversight for assigned countries in Africa for the branded Company portfolio and strategic initiatives to develop and execute regulatory strategies, processes, and plans in support of new registrations and post approval submissions

Minimum Requirements

Bachelor's degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences.
MSc, MBA or PhD may be an advantage
Experience in regulatory affairs, preferably in human medicines minimum 8 years of experience.
Experience in people management will be an advantage

Primary Responsibilities include

Manage post approval strategy (including timelines) and execution in alignment and partnering with key stakeholders (i.e. supply chain, markets, clusters, labelling team, publishing hub, CMC) to ensure a submission ready dossier for the assigned market(s).
Capable of making strategic decision for management of post approval submissions in the cluster she/he manages based on data and/or information from various sources and ensure alignment in understanding within the cluster.
Oversee complex post approval submissions for the region (e.g technical transfers), from submission planning stage up to approval by BOH.
Liaise with CMC Product Strategists. Ensure that the appropriate regulatory requirements systems and database are updated in a timely manner when changes occur in regulations for assigned markets
Ensure a submission planning and forecasting tool is utilized to update timelines, when necessary, communicate changes to relevant partners
Capable of authoring some local submission components in relevant databases
Ensure submission packages are reviewed against local CMC requirements for consistency and completeness
Liaise with the manufacturing sites for obtaining supporting documents as needed
Participate in local and regional regulatory initiatives promoting a culture aligned with Pfizer values and which supports compliance, innovation and talent development and retention.
Assist in ensuring internal regulatory processes and procedures are well documented.
Understand local regulations and trends for assigned markets and/or cluster, as communicated by the local market regulatory team.
Participate in crossregion projects and Limited Duration Team for internal processes improvement and ensure implementation consistency within the team.
Supervise & manage Regional Regulatory Lifecycle Strategists, Managers and/or Contractors when needed.
Overseeing and managing the renewal submissions to ensure timeous submission and updating of systems.

Key Knowledge and Skills Required

Regional Regulatory experience including knowledge of new submission processes and Product lifecycle management processes.
Demonstrate experience of effective delivery in a matrix environment.
Knowledge of Regional Regulatory environment
Technically competent to understand CMC submissions, interpret and communicate requirements, and identify potential risks.
Knowledge of drug development, regulations and guidelines
Leadership and management qualities, including good communication, negotiation, and interpersonal skills
Understanding of pharmaceutical industry, clinical trials and pharmacovigilance
Knowledge and understanding of quality systems, processes, audit and inspection
Capable of making a strategic decision and communicates decision to ensure understanding, alignment and implementation
Ability to influence peers in the organization
Team player
Act independently with less supervision
Analytical thinking
Change agile