Mission & tasks: Will lead the local CHC regulatory strategy and guidance to the local team ensuring compliance of the existing CHC portfolio, effective and timely approval of all marketing authorisations, maintenance, provide appropriate input on the development of new products and shape the regulatory environment. Be a partner for local business to support the delivery of business objectives within the regulatory framework.

Key contributions & activities: Ensure high quality submissions within timelines agreed with GRA, business and/or health authorities. Maintain optimal resource capacity for performing required regulatory activities. Manage the local RA budget.

Management Responsibilities:

Regulatory Compliance

• Ensure product packaging and associated information are updated, timely implemented and maintained in accordance with the current product licenses.
• Ensure that Marketing Authorizations are updated in line with Company Core Safety Information according to Corporate requirements
• Ensure local implementation of mandatory SOPs and training
• Ensure quality and compliance of local regulatory activities in line with corporate regulatory affairs, national regulations. Ensure maintenance of regulatory databases.

Health Authority Interactions

• Build credible relationships with health authorities, making Sanofi CHC a recognized partner with the agencies and providing regulatory thought leadership
• Act as interface between the company and local regulatory authorities, where reasonable.

Portfolio Management

• Review and approve promotional and non-promotional materials ensuring their competitive position and compliance with local regulations, code of conduct and internal guidelines.
• Lead the management of the local maintenance activities and ensure compliance of the marketed product portfolio
• Lead development of the Local Regulatory strategies for geographical extensions
• Manage with other functions the preparation of local dossiers for the products under development and territory extensions
• Lead development of local strategies and preparation of OTC switches
• Ensure that best efforts are provided to get timely approvals of dossiers
• Lead the regulatory due diligence for local BD opportunities, collaborating with other relevant functions and providing strategic recommendations to enable appropriate portfolio decision making
• Provide RA insight and actively identify product portfolio optimization and product pruning opportunities at affiliate level, partnering with IA, Commercial and GRA functions to deliver on product portfolio optimization strategies.

Risk Management

• Co-ordinate the local health authority approval and implementation of risk management plans and DHPCs and educational material.
• Ensure public availability of current approved product information for risk minimization (SmPC, educational material, PIL, compendia)

Latitude of Action:

Partnerships and transversal collaboration

• Develop and maintain a good working relationship with internal and external stakeholders

Role Impact:

Regulatory Environment influence

• Actively follow the development and emergence of new regulatory requirements and regulatory intelligence, ensuring that the appropriate impact assessment and company strategy are delivered to the relevant stakeholders
• Lead Sanofi CHC RA active participation in local trade associations to influence the regulatory environment to drive growth in accordance with company strategy and purpose and global corporate positions

Innovation

• Contribute and provide insight for innovation programs leading to innovative regulatory pathways to drive competitive positioning, maximize chances of approval and identify opportunities, regulatory risks and mitigation strategies
• Lead HA Interactions ensuring that all projects have clearly defined regulatory paths to deliver on the product vision and milestones are met leading to successful filings and approvals.

Scope:

The Regulatory Affairs Lead will lead the local CHC regulatory strategy and guidance to the local team ensuring compliance of the existing CHC portfolio, effective and timely approval of all marketing authorizations, maintenance, provide appropriate input on the development of new products and shape the regulatory environment. Be a partner for local business to support the delivery of business objectives within the regulatory framework.

Qualifications/ Education & work experience

• Minimum MS; Pharm D, MD, PhD or equivalent preferred
• Relevant experience in in Regulatory Affairs of at least 3 or 4 years
• Knowledge of local regulatory affairs regulation

Special Knowledge & Qualifications

• Good understanding of the consumer healthcare and pharmaceutical industry
• Knowledge of CHC regulations and requirement
• Excellent command of English language
• Greek language: native speaker

Additional Skills

• Team collaboration
• Act for change
• Think strategically and strive for results
• Strong interpersonal/communication skills
• Ability to work in a matrix environment
• Business acumen and customer orientation
• High standards of integrity
• Ability to develop strong networks and influence internal and external stakeholders