Regulatory Affairs Associate Director

Responsibilities

• For assigned products, ensure timely preparation, submission, and follow-up of new Marketing Authorization applications to local authorities and, where applicable, to the EMA.
• Ensure maintenance of assigned, authorized products through timely submission of variations, renewal applications, and supplemental marketing authorizations.
• Ensure timely, accurate and compliant labeling translations and artwork preparation for assigned products.
• Support agency interactions to enable seamless submission, assessment, and quick approval of CTAs, in cooperation with RAE Liaison and other internal stakeholders, in line with EU requirements.
• Stay updated on the company's pipeline filings, relevant EU and local regulations and guidelines; develop and maintain positive relationships with key regulatory environment players; design and implement regulatory ad-hoc local action plans as needed.
• Collect relevant publicly available regulatory information (regulatory intelligence) and keep relevant persons informed.
• Work alongside the BD function locally, regionally, and globally to support business initiatives in the sub-region.
• Maintain positive relationships with internal and external regulatory contacts. Identify main contact points within the company and with external authorities and stakeholders.
• Act as substitute for Country Lead Regulatory Affairs as appropriate.

Major Activities

• Perform timely and correct submission and approval of assigned new Marketing Authorization applications in collaboration with managing, medical, finance, customer service, marketing and external affairs teams; coordinate and implement early access programs with the Agency; track process and manage responses to objections; negotiate for favorable conditions.
• Design and implement local action plans for new products, including regulatory training of external experts and ongoing interaction with the Agency and Advisory Committee members.

Maintenance & Compliance

• Maintain licenses for assigned products to ensure compliance with regulatory areas; perform necessary activities including variations and renewals and communicate approvals to stakeholders.
• Maintain local regulatory documents and ensure proper use of artwork management and regulatory databases; contribute to SOPs and updated regulatory documents as required.

Labelling, Artwork & Documentation

• Ensure high quality translations and linguistic checks of Summary of Product Characteristics and Patient Package Leaflets; ensure availability of packaging materials and artwork in a timely, correct manner.

Cross-functional & Policy

• Provide regulatory guidance and support to cross-functional teams and partners; participate in policy-related activities and monitor regulatory changes that may impact the business.

Qualifications, Skills & Experience

• Must hold an MS degree in pharmacy or other life science or equivalent.
• At least 7 years of related experience in a Registration Department within pharmaceutical or government sectors, including direct dealings with regulatory agencies; familiar with local and EU legislation and guidelines.
• At least 1 year of people management experience is preferable.
• Excellent writing and verbal communication skills in English and Arabic; strong organizational and planning abilities.
• Attention to detail; ability to manage conflicting time pressures and a high workload; strong communication, diplomacy, and teamwork skills.
• Experience in registration processes and supervising others; client-oriented approach and alignment with leadership vision.