Associate Director

At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through science. In oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
We are hiring Associate Director, Regulatory Lead, Saudi Arabia at BMS & Scientific office manager for BMS scientific office in Saudi.

Position Summary and objectives:

• Accountable for all HA interactions at local level.
• Provide country input in Global Regulatory Plan and Global Submissions Plan.
• Execute local country submissions for clinical trials, new registrations, product renewals, and variations.
• Ensure regulatory compliance at a local level (eg. Advertising & Promotion, CCDS)
• Maintain established brands in line with strategy.
• Interface with local commercial, medical, ClinOps, legal, GPS

Position responsibilities:

• Responsible for driving regulatory processes in line with business/R&D;objectives to ensure timely registration of new products/line extensions and variation applications of BMS products.
• Responsible for assuring that approved labelling (PIL, PI, pack) is implemented in production in accordance with local legislation.
• Responsible for Regulatory translations for country and coordination of translations in country (if applicable).
• Acts as Local Health Authority Liaison with the Regulatory Agencies in country for assigned products and topics.
• Responsible for filing clinical trial applications to the competent regulatory authorities in country, and all following interactions, in line with BMS company policies and practices where applicable.
• Responsible for interactions with Country Regulatory Authorities and provide feedback to BMS regarding product registrations,
• Drives and support local projects and department related assignments.
• Responsible for identification of opportunities to improve departmental functions/processes.
• Responsible to keep up to date with the regulatory environment within the industry.
• Responsible for archiving of regulatory files and documentation, and maintenance of regulatory databases,
• Act as a key partner with the country Business function, Medical function, Clinical Operations function, Market Access function and Logistics function.
• Develop the necessary external contacts with e.g. Regulatory Agencies, Trade Associations and Wholesale distributors.
• Responsible for the review and approval of Advertising & Promotional materials in country as per the approved local label (PI, PIL) the Ethical Rules issued by local authorities and BMS s procedural documents.
• Responsible for overall regulatory related topics for country.
• Support reimbursement processes to ensure timely negotiations and approvals in accordance with business objectives where applicable.
• Promptly report knowledge (initial or follow-up) of any adverse event or quality product complaints associated with a BMS product
Technical & Scientific Office tasks:
• Maintain all legal documents updated and making sure our business is conducted in accordance with license we have. This includes but not limited to SFDA, MLSD, MISA, GAZT, etc.
• Support in all finance and banking processes related to BMS in Saudi Arabia in terms of communication with the bank or approving/uploading payments
• Handling all third-party contracts related to BMS in Saudi Arabia as the legal representative of BMS in Saudi Arabia
• Support in GAZT communications as legal representative BMS GM in Saudi Arabia. This includes sorting out any pending issues related to submissions and any other related matters.
• Support in HR processes related to BMS employees and monitor implementation of any MLSD regulations with direct or indirect impact on the company in Saudi Arabia
• Leading all government relations in Saudi Arabia as the legal representative of BMS in Saudi Arabia. This includes MLSD, GOSI, Mudad, GAZT, MOT, MOI, etc.

Requirements :

• Saudi National
• Bachelor degree in pharmacy (pharmacist)
• Professional experience with 5-7 years of relevant regulatory experience
• Up-to-date regulatory knowledge required, and experience with new drug development work
• Excellent communication skills
• Good presentation skills, excellent strategic thinking ability, good negotiation skills, excellent leadership skills, excellent problem-solving ability, excellent coaching skills, and good facilitation skills

https://www.naukrigulf.com/associate-director-jobs-in-riyadh-saudi-arabia-in-bristol-myers-squibb-5-to-7-years-n-cd-10005623-jid-310821500666