Head of Regulatory Affairs

About the role

As the , you will play a pivotal role in ensuring that our pharmaceutical products meet all regulatory requirements across various markets. Your expertise will guide the development and implementation of regulatory strategies that align with both local and international standards. This position is crucial for maintaining compliance and facilitating the timely approval of our innovative therapies, ultimately contributing to our mission of improving patient outcomes.

Key facts

What you'll do

• Lead the regulatory affairs department, overseeing a team of professionals dedicated to compliance and regulatory submissions.
• Develop and execute regulatory strategies for new product approvals, ensuring alignment with company goals and market needs.
• Collaborate with cross-functional teams, including R&D, quality assurance, and marketing, to ensure regulatory considerations are integrated throughout the product lifecycle.
• Prepare and submit regulatory documents to health authorities, including INDs, NDAs, and variations, ensuring accuracy and compliance with local and international regulations.
• Monitor changes in regulatory requirements and industry standards, advising the organization on necessary adjustments to maintain compliance.
• Establish and maintain relationships with regulatory agencies, facilitating effective communication and negotiation during the approval process.
• Conduct training sessions for internal teams on regulatory requirements and best practices, fostering a culture of compliance within the organization.
• Analyze and interpret complex regulatory guidelines and provide strategic recommendations to senior management.
• Lead the preparation for regulatory inspections and audits, ensuring that all documentation and processes are in order.
• Manage timelines and deliverables for regulatory submissions, ensuring that projects are completed on schedule and within budget.
• Support post-marketing surveillance activities and ensure compliance with pharmacovigilance regulations.
• Contribute to the development of product labeling and promotional materials, ensuring that all claims are substantiated and compliant with regulations.

Requirements

• A minimum of 8 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
• Proven track record of successful regulatory submissions and approvals in multiple markets.
• In-depth knowledge of local and international regulatory requirements, including FDA, EMA, and other relevant authorities.
• Strong leadership skills with experience managing a team and driving cross-functional collaboration.
• Excellent communication skills, both written and verbal, with the ability to convey complex regulatory information clearly.
• Strong analytical and problem-solving skills, with a keen attention to detail.
• Ability to work in a fast-paced environment and manage multiple projects simultaneously.
• A degree in life sciences, pharmacy, or a related field; advanced degrees (Master's or PhD) are preferred.
• Fluency in English; proficiency in Arabic is a plus.

Nice to have

• Experience in emerging markets and knowledge of regulatory pathways in those regions.
• Familiarity with electronic submission systems and regulatory databases.
• Previous experience in a global regulatory role or with multinational companies.
• Certification from a recognized regulatory affairs organization (e.g., RAC) is advantageous.

Skills & tools

• Proficient in regulatory submission software and tools, including eCTD systems.
• Strong project management skills, with experience in using project management software.
• Familiarity with quality management systems and compliance tracking tools.
• Competence in data analysis and interpretation, particularly in relation to regulatory metrics.
• Knowledge of pharmacovigilance processes and safety reporting requirements.

Practical notes

• This position is based in Cairo, Cairo, and may require occasional travel to meet with regulatory agencies or attend industry conferences.
• The salary for this role will be competitive and commensurate with experience, reflecting the importance of this leadership position within the organization.
• Acino is committed to providing a supportive work environment that fosters professional growth and development.

If you are a strategic thinker with a passion for regulatory affairs and a desire to make a meaningful impact in the pharmaceutical industry, we encourage you to apply for the Head of Regulatory Affairs position at Acino. Join us in our mission to enhance patient health through innovative therapies and ensure that our products meet the highest standards of safety and efficacy.