Senior Regulatory Affairs Specialist

Job Title: Regulatory Affairs Lead

Location: 190 BD D'ANFA 1ER ETAGE, CASABLANCA, Maroc

Department: Regulatory Affairs

About Biocon Biologics

Biocon Biologics is a global biopharmaceutical company committed to transforming healthcare and making high-quality biosimilars accessible to patients worldwide. With a strong presence across emerging and developed markets.

Role Overview

We are seeking an experienced and strategic Regulatory Affairs Lead based in Morocco to oversee regulatory activities across a broad and diverse region—including Middle East Asia, CIS, and Africa (including South Africa). This role is pivotal in driving regulatory excellence, ensuring compliance, and enabling market access for our biosimilar portfolio.

Key Responsibilities

* Lead and manage regulatory submissions and approvals across assigned regions
* Develop and implement regional regulatory strategies aligned with global objectives
* Liaise with health authorities, partners, and internal stakeholders to ensure timely approvals
* Monitor and interpret regulatory changes, providing strategic guidance to cross-functional teams
* Support lifecycle management and post-approval regulatory activities

Qualifications & Experience

* 10–15 years of experience in Regulatory Affairs, preferably in biologics or pharmaceutical products
* Proven track record of managing complex regulatory landscapes across multiple geographies
* Strong understanding of regional regulatory frameworks and submission requirements
* Excellent leadership, communication, and cross-functional collaboration skills
* Fluency in French is essential for effective regulatory engagement
* Ability to work independently and influence across cultures and time zones

Additional Information

* Work Location: Casablanca, Morocco