Regulatory Affairs & Scientific Office Manager Saudi Arabia

With a unique legacy in dermatology as well as decades of cutting-edge
innovation, Galderma is the leading company solely dedicated to skin and
advancing the future of dermatology.
We look for people who focus on getting results, embrace learning and bring a
positive energy. They must combine initiative with a sense of teamwork and
collaboration. Above all, they must be passionate about doing something
meaningful for consumers, patients and the healthcare professionals we serve
every day. We aim to empower each employee and to promote their personal
growth all the while ensuring business needs are met now and into the future.
Across our company, we embrace diversity and respect the dignity, privacy and
personal rights of every employee.
At Galderma, we actively give our teams reasons to believe in our ambition to
become the leading dermatology company in the world. With us, you have the
ultimate opportunity to gain new and challenging work experiences and create
unparalleled, direct impact.
Job Description
REGULATORY AFFAIRS & SCIENTIFIC OFFICE MANAGER - SAUDI ARABIA
Location: Riyadh, Saudi Arabia (Galderma Technical Scientific Office)
Direct Reporting to: Head of Regulatory Affairs Middle East (based in Dubai)
Education & training: Pharmacist Degree / Bachelor's degree in pharmaceutical
science. Saudi Arabia MoH licensed pharmacist.
Experience: At least ‎8-‎10 years in a similar Regulatory Affairs role in field
of prescription medicinal products. In-depth understanding of the
pharmaceutical industry within Saudi Arabia, and strong connections with SFDA.
Quality experience, and experience with medical devices and/or cosmetics
preferred.
Core Mission:
The role focuses on leading, shaping, driving, and executing all Regulatory
Affairs and Pharmacovigilance priorities for all product classes (medicinal
products, medical devices, cosmetics) across Saudi Arabia, managed through
promotional distributors:
* Lead and manage the entire registration process in ensuring approvals of new products, manufacturing permits, import permits, and amendments to products:
* Lead regulatory strategy development to enhance speed to market for new product development, and lead execution. Ensure new license applications are submitted within agreed project timelines, and approvals are obtained as planned.
* Ensure compliance with, and maintenance of, existing licenses.
* Provide strategic directions to the business, accountable for delivering project goals and aligning functional strategies with business needs.
* Lead interactions and negotiations with Saudi FDA
* Shape the regulatory environment in Saudi Arabia, driving an agenda to create an external environment in which our portfolio can thrive. Build a network with external experts.
* Active partnership with distributors. Develop effective relationships with distributors
* Ensure scientific office responsibilities are fulfilled. Act as the point of contact of the company in front of the authorities. Ensure all company's pharmaceutical products are manufactured, distributed, and registered in compliance with the local regulations.

Key Duties & Responsibilities:
Lead Regulatory Affairs:
* Lead the regulatory strategy and execution efforts, ensuring regulatory advice and input is proactively provided to local business strategies with regards to feasibility, requirements, and timelines, taking into account local requirements and local business needs.
* Act as liaison between Regulatory Affairs and other functional areas; represent Regulatory Affairs in cross-functional team meetings. Coordinate with Corporate, Regional Regulatory Affairs and the management of Galderma, registration priorities, strategies, and preparation of dossiers for new and old products. Support global new product & life cycle management-projects, in co-operation with Corporate Regulatory Affairs, R&D, QA and external experts (if applicable) as well as participation in the concerning working groups.
* Ensure high quality and timely submissions, coordinating with distributors or third parties where applicable.
* Prepare and submit regulatory affairs applications such as new product registrations (including geographical extensions and variations (e.g. extension of indication) across regulatory product classes (prescription drugs, OTC drugs, cosmetics, and medical devices) to meet country's business objectives and timelines. Facilitation of all aspects of these applications including submission, responses to questions and negotiations with the Health Authority
* Perform regulatory maintenance of registered products or ingredients (including review of product inserts, submissions of variations and permits) to ensure products remain compliant with all relevant government, industry and corporate requirements throughout their marketed life. To this end, ensure product packaging and associated information are updated, timely implemented, and maintained in accordance with the current product licenses, as well as ensure that Marketing Authorizations are updated in line with Company Core Safety Information according to corporate requirements
* Review proposed product labels for regulatory assessment and submit to register label changes to the relevant health authority with the aim of attaining the most competitive product labels (whilst maintaining ethical standards) and the earliest possible commercial launch
* Ensure that progress of applications and changes to registered details are communicated to local and global stakeholders, as appropriate, with minimum delay. Support & facilitate launch of new products by collaboration with Marketing, Supply Chain / Production, Finance, Corporate and General Management.
* Manage in-house regulatory files, documentation and Corporate electronic databases ensuring that all files are up-to-date and compliant.
* Keep abreast of relevant regulatory, industry, legislative, political and competitor activities to define business impact and to develop appropriate regulatory strategies accordingly for Galderma's product portfolio.
* Ensure review and approval of promotional and non-promotional materials ensuring their compliance with local regulations (such as Saudi Code of Pharmaceutical Promotional Practices in the Kingdom of Saudi Arabia), code of conduct and internal guidelines. Coordinate review with the responsible functions in the country. Ensures consistency and conformity to the various published guidelines and codes of practice.
* Revision of officially approved texts for packaging materials, package inserts and SmPCs and Co-ordinate artwork amendments and tracking of packaging modifications by liaising directly with marketing, regulatory affairs, packaging, manufacturing and/or third parties as appropriate.
* Develop and manage effective working relationships with Health Authorities. Organise and prepare for meetings with Regulatory Authorities. Represent the Company with the competent authorities, standardization bodies and professional associations (if applicable). Build a network with external regulatory experts.
* Initiate and/or contribute to local process improvements. Manage a team of regulatory affairs officers.
* Ensure local implementation of GRA mandatory SOPs and training.
* Review from a functional perspective, service provider contracts, distribution agreement, as well as Trademark registration across the zone.
* Undertake any further duties from time to time as may be reasonably required by the company.
* Negotiation with the SFDA about the pricing and keep the stakeholders informed about any changes/updates in pricing regulation, support price appeals review and submissions to SFDA.
* Ensure compliance with SFDA regulation as part of responsible pharmacist duties in front of Saudi Arabia authorities
* Lead health authority inspections
Lead Pharmacovigilance:
* Act as the Local Safety Officer (LSO) for Saudi Arabia
* Maintain the local PV Quality Management System and monitor its compliance status
* Manage the creation/update of local PV SOPs to reflect local practices in accordance with Corporate Policies and SOPs
* Coordinate with Partners in KSA for preparation and maintenance of Safety Data Exchange Agreements, Regulatory Intelligence for PV requirements and effective management of adverse events and aggregate reports
* Support of Pharmacovigilance activities managed by the Partners' Local Safety Officer (LSO) to ensure compliance with regulations and Company's guidances; coordinate and exchange key information with the Middle East PV team
* Perform Pharmacovigilance specific tasks including but not limited to processing spontaneous reports of adverse events, Literature monitoring, aggregate reports administrations and submission according to KSA regulations and other PV activities as required e.g., data reconciliation, signal alerts and archiving, update on the safety agreements and preparation for internal audits or Health authority inspections
* Receive spontaneous reports of adverse events, follow-up adverse events as comprehensively as possible, communicate adverse event information to the Galderma Corporate pharmacovigilance department, and report adverse event information to relevant regulatory authorities
* Coordinate with global PV team updates in the local requirements related to periodic reporting and required format and covered period to support preparation of the global PV calendar
* Manage and submit Periodic Safety Update Reports (PSURs), according to national standards for products in scope, in co-operation with Corporate Pharmacovigilance
* Ensure compliance with local regulations and internal processes; coordinate PV audits of partners with Corporate PV
* Ensure relevant PV training of Partners' LSOs
Scientific office responsibilities:
* Obtain and maintain a valid license for the scientific office
* Providing technical information and assistance regarding the products to the distributor and to end users
* Respond timely and effectively to authorities' inquiries
* Support in issuing official letters to Governmental bodies
* Governmental representations
* Maintain good relations with distributors and business partners
* Train staff, if applicable
Others:
* Adhere to related laws, regulations, Galderma Code of Ethics, and any other applicable Codes and SOPs.
* Ensure compliance to Galderma policies and procedures
Galderma is the world's largest independent dermatology company, present in
approximately ‎100 countries. Since our inception in ‎1981, we have been driven
by a complete dedication to dermatology. We deliver an innovative, science-
based portfolio of sophisticated brands and services across Aesthetics,
Consumer Care and Prescription Medicine. Focused on the needs of consumers and
patients, we work in partnership with healthcare professionals to ensure
superior outcomes. Because we understand that the skin we're in shapes our
life stories, we are advancing dermatology for every skin story. For more
information, please visit our website: https://www.galderma.com/careers