Rare Diseases/Immunology Regulatory Lead

ABOUT THE JOB:

JOB PURPOSE:

• Accountable to ensure that regulatory activity is submitted and approved in due time.
• Develop relations with key regulatory authorities at a country level; discuss issues and find solutions in the best interests of company.
• In alignment with Country Head and other BU/TA heads in the country, analyses and communicates any changes in the regulatory area and liases with pertinent Sanofi functions to ensure implementation of new ways of working as per need.
• Works to ensure “one Sanofi” position in front of country HA, aligning priorities between the different GBUs and the regulatory country head/lead.
• As per need and upon delegation of the country head/lead be Sanofi´s representative in pharma chambers / associations and ensure representation of company in HA working groups / public consultations.
• Participates and contributes to the definition and implementation of strategies to prepare external regulatory environment to accommodate innovation.
• Provide regulatory expertise within the specific GBU / TA commercial teams, ensuring total compliance with legal requirements and ethical norms.
• Focal point for Regional / global regulatory product, COE or CMC leaders to discuss strategies for registration, submission and approval of new MA´s and variations in the country.
• Ensures, in alignment with country/MCO head, execution at local level of regulatory strategy to maximize attendance of commercial strategies (GRA Blue Print principle).
• Collaborates with other GRA function to ensure dossiers submitted to HA are maintained and updated in line with current regulatory standards and legal requirements.
• Manages portfolio rationalization activities, aligning GRA objectives with affiliate objectives.
• Works to assure Sanofi teams globally are well knowledgeable on country HA requirements (trainings and database updates).
• Manages team to support business needs within the different GBUs: Promo and non-promo material approval, product strategies (new products and LCM) discussion and implementation, regulatory input – trends and competitors intelligence – in Brand teams.
• Be responsible for regulatory risk assessment and management.
• Ensure Regulatory support for product crisis (shortages, discontinuation, counterfeit, recalls).
• Controls all activities of the team reporting to him, ensuring that staff is qualified and competent, properly coached, given the opportunity to develop in the company and enable them to handle the demands of their jobs and achieve their objectives.
• Manage BU/TA budged following companies processes and in alignment with country / MCO Head
• Ensure team acts in compliance with company's directives and policies

KEY ACCOUNTABILITIES:

• Accountable for all Sanofi regulatory activities related to products assigned to a specific Business Unit and/or Therapeutic Area in a country or multi-country / Zone organization.
• Ensures the implementation of regulatory strategies and projects to obtain marketing authorization for new products and existing portfolio, having as ultimate goal regulatory compliant products to be commercialized according to business strategy.
• Responsible to interact with all the appropriate stakeholders to ensure compliance of the products according to regulatory requirements and Sanofi policies.
• In alignment with the regulatory country / MCO/ Zone Head represents the Business Unit at the Regulatory Health Agency of the countries under his responsibility.
• Ensures regulatory environment and requirements are well understood and considered in product business strategies.
• Is the Qualified Person registered at the HA level, if applicable.
• Leads and develops the Regulatory Associates team reporting to him in alignment with Country/MCO/Zone Regulatory Head directions.

ABOUT YOU:

• Education: Pharmacy Degree
• Excellent understanding of the pharmaceutical industry, drug development environment, and company processes and objectives.
• Expert knowledge of country/MCO pharmaceutical 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 authorisations, 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 organisational 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 multifunctional and multicultural teams.
• Fluent English.
• Awareness and adherence to company internal SOPs & compliance standards.
• Promptness in response to authority's requirements and prompt in deliverables.
• Analytical skills.
• Problem solving skills.
• An understanding and appreciation of relevant legal, scientific and manufacturing area.

PLAY TO WIN BEHAVIORS
- Push to go beyond the level we have operated until now:
Constantly challenge the status quo focusing on the priorities that will deliver the best outcomes and letting go what won’t: be intolerant to mediocracy, believe we can and must do better and aim at higher but never at the expenses of our values and judgment.
- Put the interest of the organization ahead of own of those of his/her team:
Consider both short- and long-term impact of decisions; puts collective and global goals above individual or local goals; share resources and capabilities with those with the greatest need and impact; enable decision making at appropriate level.
- Act in the interest of our patients and customers:
Actively engage with customers to know their current and future needs; brings an external perspective into decisions.
- Take action and don’t wait to be told what to do:
Take smart and informed best bets with the information at hand and anticipate the consequences of her/his actions; use personal judgement and others’ advice to make bold and impactful decisions which move us forward.

Pursue progress, Discover Extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and inclusion actions at sanofi.com!

Sanofi IS AN EQUAL OPPORTUNITY EMPLOYER If you are interested in applying for this vacancy and you are confident that you meet the criteria set out in the advertisement kindly click on the link below.
https://sanofi.wd3.myworkdayjobs.com/SanofiCareers
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