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Regulatory Affairs & Scientific Office Manager
Title: Regulatory Affairs & Scientific Office Manager
As a Regulatory Affairs & Scientific Office Manager – Personal Health? You will be responsible for planning and managing regulatory activities on both new and in-line products in accordance with authorities. Manage the Scientific Office for P&G Health in Saudi Arabia.
Manage the Regulatory Affairs in Saudi Arabia particularly to ensure and achieve timely execution of below items to contribute to the profitability and growth of the Personal Health Care Business Unit: registration of all products as per submission plan • maintenance of existing products o provision of internal scientific support • Collaborate and establish a network with business partners • Ensures all allocated products are compliant with internal policies and procedures and relevant external regulatory requirements • Build constructive and positive rapport with regulatory authorities in Saudi Arabia.
PLANNING: Development of registration plan for products under his/her responsibility, Saudi Arabia. REGULATORY PROCESS: Preparation of market-specific file compilation/ documents e.g. application forms, summary sheets and clarification letters. He/she executes the agreed plans by coordinating dossier submission within planned timelines and obtain Regulatory Agencies approvals for new products, line extensions , new indications and/or site registration to meet the launch plans; Act as first point of contact with the health authorities and regulatory personnel at distributors. REGULATORY COMPLIANCE: Ensure that all marketed products in the country are in compliance that meet local and corporate regulatory requirements, i.e. (Product Information and packaging development); label change management; chemistry and manufacturing commitments that were registered with the authorities. Updating the regulatory systems and tracking sheets as applicable. REGULATORY AFFAIRS INFLUENCE: • External: • Drive and maintain regular contact/relationship with key regulatory officials • Maintain contact and liaise with key business partners externally. • Monitor, understand and influence the local regulatory guidelines and requirements• Internal: • Represent the team and participate in cross functional teams with local/regional commercial and regional/global functions related to assigned products • Cooperating with internal customers as necessary to ensure successful strategy implementation.
We are looking for:
• Saudi national
• Must be a licensed pharmacist by the Saudi Council of Health Specialities
• Good professional attitude, willingness to learn, strong collaborative skills.
• Ambitious team player who leads from the front, shows flexibility and is committed to delivering exceptional business results.
• Strong initiative and follow-through with accountability for work quality
• Organization skills and solution-oriented attitude to handle a complex product-country portfolio
• Excellent attention to detail, good communication and presentation skills
• Results oriented and self-motivating with an ability to influence others
• Openness to change and ability to think out of the box
• 3-5 years' experience in Regulatory Affairs withing the industry (preferably within the consumer health division) or a regulatory body.
• Depth of expertise in own specialized discipline or field combined with knowledge of the market and competitors.
Just so you know:
We are an equal opportunity employer and value diversity at our company. Our mission of Diversity and Inclusion is: “Everyone valued. Everyone included. Everyone performing at their peak”.
What P&G will offer?
You will have business responsibilities from Day 1 – You will start of working on key brands from the beginning. Over time, as you expand your impact on the business, your responsibility and ownership will quickly grow.
You'll be recognized state of the art Marketing Research skills – We will constantly help you improve your knowledge and management abilities.
You will receive continuous coaching & mentorship– We are passionate about our work. We will make sure you receive both formal training and as regular mentorship from your manager and others.
You will work in a dynamic and respectful work environment – We live our Purpose, Values, and Principles daily. We value every individual and encourage initiatives promoting agility and work/life balance.
For over 180 years, Procter & Gamble has created some of the world’s most successful brands, including Pampers®, Ariel®, Tide®, Pantene®, Gillette®, Vicks®, Neurobion®. We believe in serving the consumer and ensuring our organization, talent and brand building reflects the diversity and needs of the approximate 5 billion people around the world we serve through our brands. We value leadership as well as mastery and offer fulfilling career opportunities that make us an unbeatable force in our industry.
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