Associate Director, Regulatory Affairs at MSD - Saudi Arabia

MSD, a leading global biopharmaceutical company, is seeking a highly experienced professional for the position of Associate Director, Regulatory Affairs in Saudi Arabia. This role presents a remarkable opportunity to join a world-renowned healthcare leader and contribute to its mission of discovering, developing, and delivering innovative medicines and vaccines to save and improve lives worldwide.

Job Description and Key Responsibilities

The Associate Director, Regulatory Affairs will hold a strategic leadership position within the local MSD team in Saudi Arabia. The core focus will be on leading and executing regulatory strategies to ensure full compliance with local regulations and facilitating the timely market access of innovative products. The successful candidate will serve as the primary interface between the company and relevant Saudi regulatory authorities, such as the Saudi Food and Drug Authority (SFDA).

Key responsibilities for this role are expected to include:

• Leading the development and implementation of regulatory registration strategies and plans for new products, renewals, and variations in the Saudi market.
• Preparing, submitting, and reviewing high-quality regulatory registration dossiers and technical documentation to meet strict regulatory deadlines.
• Managing all communications and negotiations with local health authorities to ensure a clear understanding of requirements and expectations.
• Monitoring changes in the Saudi regulatory landscape, assessing their impact on company products and processes, and providing proactive recommendations.
• Ensuring ongoing compliance with all relevant laws, regulations, and ethical standards.
• Providing guidance and support to team members (if applicable) and fostering a culture of excellence and continuous learning.
• Collaborating closely with cross-functional internal teams such as Medical Affairs, Marketing, and Operations to achieve strategic business objectives.

Essential Qualifications and Requirements

MSD is looking for candidates with a proven track record of success in regulatory affairs within the pharmaceutical or healthcare industry. The required qualifications include:

• A Bachelor's degree in Pharmacy, Biomedical Sciences, or a related field. A Master's degree or PhD is a strong advantage.
• Minimum of 8-10 years of hands-on experience in Regulatory Affairs within the pharmaceutical industry, with demonstrated experience interacting with health authorities in the Middle East region, specifically in the Saudi market.
• In-depth and current knowledge of the regulations, guidelines, and procedures of the Saudi Food and Drug Authority (SFDA).
• Proven experience in filing New Drug Applications (NDAs), renewals, and variations.
• Exceptional communication and leadership skills, with the ability to influence and build strong relationships with internal and external stakeholders.
• Ability to thrive in a fast-paced, dynamic environment, managing multiple projects with competing priorities.
• Full professional proficiency in English (written and spoken). Arabic language skills are a significant advantage.

Why Work at MSD?

Joining MSD means becoming part of an organization that puts patient health at the forefront. The company offers a stimulating work environment that supports innovation and professional growth. While specific details were not mentioned in the initial posting, MSD is widely known for offering a competitive benefits package which may include comprehensive healthcare, retirement plans, continuous professional development opportunities, and a supportive work culture.

How to Apply for the Position

Applications for the open "Regulatory Affairs Associate Director" position at MSD are being accepted through the Naukrigulf online platform. Qualified candidates who meet the above criteria are advised to visit the original job posting link (provided in the source information) or search for the vacancy on the official MSD careers website for the region. It is recommended to prepare an updated, targeted resume that highlights relevant experience and achievements in regulatory affairs, particularly those related to the Saudi market, along with a compelling cover letter stating your motivation for applying.

This is an excellent opportunity for an ambitious and seasoned regulatory professional to lead the regulatory efforts of a global corporation in a vital and growing market like Saudi Arabia, directly contributing to bringing advanced therapies to patients.