Regulatory Affairs Lead & Scientific Office Manager KSA

Job Description

JOB PURPOSERole Requirement: Saudi National - Role will be based in RiyadhWithin the framework of Sanofi?s global business strategy, implement an operating plan as fixed by the Head of Scientific Affairs (SA), that contributes to maximize the benefit of our products for patients, in compliance with local regulations and company standards.

• Embedding best-in-class capabilities which will put regulatory at the heart of our success
• Driving transformation focused on excellence in execution, adopting innovative approaches, simplification, including optimization of processes, and embracing digital as part of the strategic roadmap
• The Country Regulatory Affairs Lead will be responsible for leading a CHC portfolio of development and marketed products in one or several therapeutic area(s). In this capacity, he/she will be accountable for overall regulatory strategy for the products in the assigned portfolio.
• The Lead will also be the Scientific Office Manager for Sanofi CHC legal entity & run the SO efficiently ensuring compliance to local regulations.

To achieve success, it is critical that the Regulatory Lead ensures:

• Registration KPIs
• Compliance: Maintaining an up to date database (VEEVA)
• Health Authority Contact Reports
• Follow up with maximum efficiency the registration approval process in line with the local business strategic plan; provide clear, accurate and on-time information to authorities, in order to ensure rapid and successful registration.
• Develop and provide detailed understanding of regulatory processes of key agencies in KSA
• Improve strong partnerships with cross functional teams ensuring regulatory input is provided to internal stakeholders.
• Communicate and analyze current pricing practices/trends and impact on new product registration. Working on price certificates and appeal letters.
• Track, review/analyse and circulate latest regulatory information and publications on Sanofi and competitor products
• Anticipate risks and actively seek alternatives and be proactive in proposing solutions to stakeholders. Plan & execute mitigation plans to ensure all risks captured in risk register are timely updated & steps are taken to ensure business continuity
• Confirms regulatory compliance and all promotional materials addressed to market for local legislation.
• Contribute to RA strategies by providing proactive RA support taking into account local RA requirements and local business needs.
• Help network & develop plans with Corporate Affairs Lead & Transversal Teams along with Local Regulatory Authorities to keep the priority of shaping the external environment on track

KEY RESULTS / ACCOUNTABILITIESTo achieve success it is critical that the Regulatory Affairs Lead:

• Ensure compliance of the product portfolio to the legal requirements of the markets
• Maintains knowledge of regulatory requirements and environment up to date
• Work closely with Internal and external stakeholders
• Support the submission preparation and approval execution for all Regulatory activities as aligned with Business needs
• Working closely with Pharmacovigilance & Medical to ensure timely submissions & follow up on products alerts & periodic reports
• Carrying the planned Activities and reflecting the approvals on the internal systems
• Work closely with supply chain to ensure labelling implementation
• Plan for preparation / review and submission of all the maintenance activities, new applications based on company plans and the agency guidelines, this includes working with COE.
• Timely implementation of all plans with strict follow up with both internal & external stakeholders for timely achievement of the plan.
• Maintain the products labelling up to date, implementing global and local labelling decisions, through labelling preparation, review and approval
• Updating the internal Sanofi Systems regularly
• Carrying the planned life cycle management (LCM) activities and reflecting the approvals on the internal systems
• Revision and approval of promotional materials.
• Following and complying with all the defined internal policies and procedures of working.
• Following strictly all the Authority Regulations, decisions & decrees.
• Carry out all the required communication and follow up required with local affiliate, zone, region & corporate as appropriate.
• Working with SC & Quality to report shortage alert to HA.
• Grant HA approval to import certain quantity of product to avoid possible shortage if needed.
• Working with brand team to set product strategies.
• Provides leadership to and along with New Product Development, including Rx-to-OTC switches, and Commercial in identifying new product and claims opportunities, regulatory enabling opportunities, generate product evaluation summaries and novel regulatory development pathways that will ultimately drive business growth
• Responsible for the overall registration strategies, coordination, implementation, execution, control and completion of product registrations in KSA which is achieved by ensuring timely submission and driving approval through compliance of all Regulatory Activities in KSA.
• Primary Regulatory partner for Industrial affairs and Supply team
• Maintains knowledge of regulatory requirements up to date and provides regulatory intelligence and guidance on the changes (on going and future) to local Regulatory on regulations and guidelines including assessment of their impact on Sanofi?s portfolio and business.
• Support the submission preparation in providing updated requirements and reviewing local documents
• Support communication with our local agents and distributors to achieve successfully submission, follow-up and approval of all regulatory activities managed by the Health Authorities in KSA
• Maintain the regulatory tracking and planning tools in line with Sanofi?s Standard Operation Procedure.
• Ensure compliance to company policies, Health Authorities and Pharma Industry Codes.
• Monitor and set timelines for licence variations and renewals submissions and approvals, through ensuring maintenance of registered products in coordination with Global Regulatory Affairs, Supply, Customer Service, Commercial and Distributors to secure business continuity.
• Review and approves promotional material and activities in accordance with national legalisation and Codes of Practice and company policies and procedures.
• Active Core member of cross-functional project teams within the organization.
• Scientific office (SO) Manager
• SO manager for Sanofi CHC legal entity will represent & ensure efficient management of SO in line with local regulations
• Ensure the information used in marketing for registered products is as per the approvals provided by SFDA
• Support Scientific activities as required by SFDA
• Ensure used information is accurate in marketing of registered medical products for represented company and confirm it matches with approved information from SFDA
• Support scientific activities in related fields of registered medical products of represented company and participate in scientific meetings and workshops of continuous medical education
• Follow up on import & export related issues for medical products of represented company
• Follow up on medical products of represented company after registration and marketing and inform SFDA about any observation regarding product quality, efficacy and safety of its products as per regulation of pharmacovigilance in country
• Maintain Compliance
• Abide by the requirements of the internal Code of Ethics including but not restricted to maintaining high professional standards of conduct in line with the Company procedure with a duty of care to the reputation of the Company

• Ethical Leadership
• Takes personal accountability to use personal experience and knowledge, as well as the training and tools provided by Sanofi, to maintain a good knowledge and understanding of all ethics and governance relevant to the role and demonstrate personal leadership in applying these to all work undertaken.
• Escalates any decisions, or seek the support of colleagues or management if personal knowledge and understanding is not at the level required to carry out any part of the role

• Environmental and Safety Leadership
• To care for his/her own safety and wellbeing and the safety of others, and to co-operate with the company to ensure a safe place of work. Employees are therefore expected to:
• Support and conform to Company safety rules and procedures to ensure a safe and healthy working environment
• Thoroughly read all safety documentation issues by the Company and comply with its requirements. Escalate any doubts or uncertainties to their supervisor and / or manager.

KEY WORKING RELATIONSHIPSINTERNALCross Functional Collaboration with:

• CMC & Global / regional Regulatory
• Regulatory Excellence teams
• Zone, Regional Science teams
• Market Access and Pricing
• Medical Affairs
• Pharmacovigilance
• Quality
• Growth Hub
• IA & Supply Chain
• Business Operations

Occasional Contact with:

• Legal
• Compliance
• Supply chain
• Business units

EXTERNAL

• SFDA
• Vendors/service provider
• Manufacturer associations
• Agents / Distributors

SKILLS, EXPERIENCE & KNOWLEDGE REQUIREMENTS

• We are looking for a Saudi National
• Bachelor?s Degree in Medical or Scientific field of study (e.g. Pharmacy, Chemistry or Biology)
• Valid License to operate in KSA Mandatory
• Minimum of 3-4 years of related experience in Regulatory Affairs, Quality assurance, Scientific office in KSA
• Expert knowledge of SFDA/GCC regulations and requirements, Health related regulations (i.e. ICH, FDA, EU, WHO, ANSM, MHRA, Emergent Markets, etc.).
• Ability to evaluate the impact of the regulations on drug development and the regulatory maintenance of Marketing Authorizations.
• Ability to communicate effectively and efficiently with other functional departments in the business and with Health Authorities.
• Knowledge of applicable regulations and laws which regulates Pharmaceutical Products and manufacturers.
• Fluency in both Arabic and English
• Independent, proactive and optimistic personality with strong problem solving skills
• Action orientation and strong ability and willingness to learn new things quickly
• Excellent organization skills and ability to work on a number of projects with tight timelines is required.
• Excellent verbal and written communication and interpersonal skills
• Excellent teamwork skills
• Influencing & Lobbying Skills
• Project management

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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