Vaccine Regulatory lead

JOB PURPOSE:

• Report to country Regulatory Affairs Head.
• The Regulatory Lead will be responsible for leading the portfolio of development and marketed products in scope for Egypt and Sudan
• Will act as focal point/ business partner for different interactions with the commercial and medical teams as required.
• Will be accountable to overall regulatory strategy for products in his/her portfolio.

KEY RESPONSIBILITIES AND DUTIES:

• Responsible for managing the regulatory strategy, the on-time delivery of compliant major submissions to Regulatory Agencies and for the delivery of responses to Regulatory Agencies questions.
• Responsible to adhere to and advise others on Regulatory Authority regulations and guidance’s.
• Ensure compliance to all regulatory activities with all applicable laws, regulations, regulatory authorities’ requirements and company internal procedures.
• Provide guidance to various teams and stakeholders across the organization on regulatory requirements/policies for development and marketed products,
• Participate in discussions/meetings with Regulatory Authorities as required.
• Participate in other projects and activities, such as leading implementation of changes to processes.
• Accountable for keeping the databases updated on a timely basis for portfolio in scope.
• Adhere to internal KPIs and avoid deviations in activities in scope.
• Provide support and communicating information on products to other concerned functions (submissions, approval.,…etc)
• Being the main focal point to commercial and other local and global stakeholders to discuss strategic topics related to portfolio in scope.
• Liaise with HA contact person, organizing and preparing HA meeting.
• Follow regulatory changes, competitor’s status and assess potential impact on daily activities and projects strategy.
• Work in compliance with Sanofi Quality Documents (QDs).
• Lead discussions related to complex topics and provide proposed solutions to avoid business impact.
• Develop good relationship with third parties, agents providing regulatory guidance and stakeholders managing in/out license projects, acquisitions (as applicable).
• Responsible for managing divestment projects and all related discussions (as applicable).

Others:

• Perform other duties as assigned.
• Respect company’s values, code of ethics and social charter.
• Respect personal data protection charter.
• Responsible for applying the HSE related requirements for the company in all related working procedures.

Maintain Compliance 

• Abide by the requirements of the 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 (including the Industry Code of Practice, Sanofi Policies and Procedures and any relevant legal requirements) and demonstrate personal leadership in applying these to all work undertaken.

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
• Report any accident, incident or near miss, whether it be of personal injury or property damage
• Thoroughly read all safety documentation issues by the Company and comply with its requirements.

Health, Safety and Environment Responsibilities

• Comply with company procedures and current regulations on hygiene and safety.
• Properly use the work equipment, dangerous substances, and preparations as well as the supplied collective and personal protective equipment according to the instructions received.
• Promote and follow the HSE rules and ‘Act responsibly’ to protect yourself and others from an injury and ill health conditions while at the work locations and/or while using road e.g. traffic rules, emergency evacuation procedure, medical surveillance, healthy lifestyle etc.
• Engage the HSE department in the related activities (where applicable) and be sure that the work performed follows the local HSE regulations, Corporate HSE Policy and key requirements.
• Attend HSE training.
• Promptly report to your superior any dangerous conditions of which you become aware

JOB-HOLDER’s ENTRY REQUIREMENTS:

Education:

• Bachelor of Pharmacy

Related Experience:

• 8 years of experiences in Regulatory Affairs.
• Demonstrated ability to independently lead submission teams and implement regulatory strategies. And Project management experience in regulatory environment.

Special Knowledge/Skills:

• Excellent understanding of the pharmaceutical industry, drug development environment, and company processes and objectives.
• Expert knowledge of country regulations and requirements.
• Ability to evaluate the impact of the regulations on drug development and the regulatory maintenance of Marketing Authorizations, and to propose solutions integrating the mid/long term business strategy.
• Comprehensive knowledge and operational expertise of the international regulations.
• Ability to produce written and oral regulatory or scientific communications with clarity, accuracy and rigor.
• Strong interpersonal skills to motivate his/her team and liaise effectively with internal and external contacts.
• Ability to interact and communicate effectively and efficiently with other functional departments in the business and with Health Authorities.
• Good organizational skills and ability to manage a large workload under pressure and to cope with tight deadlines. Ability to foresee and respond to potential problems and opportunities.
• Ability to quickly gain required therapeutic / product knowledge.
• Ability to act as a Business Partner.
• Ability to work with agility and autonomy.
• Multitasking while being highly focused to deliver with high quality standards.
• Ability to work with multifunctional and multicultural teams.
• Fluent English.
• Awareness and adherence to company internal SOPs & compliance standards.
• Promptness in respond to authorities’ requirements and prompt in deliverables.
• Analytical skills & Problem-solving skills (detailed oriented personality)
• An understanding of relevant legal, scientific and manufacturing area.

PTW Behaviors:

• Stretch to go beyond the level we have operated at up until now.
• Take action instead of waiting to be told what to do.
• Act in the interest of our patients & customers.
• Think one sanofi