Drug Regulatory Affairs Partner

PURPOSE:
The Drug Regulatory Affairs Partner’s responsibilities are typically for regulatory activities across the product lifecycle, from early development through post-marketing activities. Develops and manages execution of regulatory strategies, regulatory projects, regulatory submissions and associated activities to ensure rapid and optimal registration for new products and indications, as well as line extensions and ensuring the effective and compliant regulatory maintenance of existing products. With teams, have interactions with local health authorities. With teams, develops and cultivates external relationships, such as with health authorities and other stakeholders or influencers. Ensures regulatory activities result in the timely approval and broadest use of products. Ensures regulatory activities are appropriately aligned with regional and global regulatory direction and guidance. Ensures timely, accurate and compliant regulatory documentation, standards, systems and procedures for regulatory activities. Helps ensure affiliate inspection-readiness at all times, as this relates to regulatory documentation and other regulatory activities. May participate in internal and external audits and post-auditing activities to address audit findings. Selects, develops and evaluates employees ensuring the efficient operation of the function.
DUTIES & RESPONSIBILITIES:
Strategy/planning:
Shape the regulatory environment by taking leadership roles in industry associations on regulatory policy and regulations.
Contribute to and influence global regulation and business needs. 
Own regulatory intelligence gathering and dissemination across the Affiliate; involving regional and global organizations when appropriate. 
Lead regulatory affairs input into cross functional Affiliate business strategies (e.g. market access, medical affairs, promotional activities, public policy, technical assessments, technical agreements, local manufacturing/packaging activities, legal issues, etc...) 
Lead and develop innovative, risk-based regulatory strategies and work plans for all products across the Affiliate to accelerate access in alignment with global. 
Fillings:
 Lead and provide strategic oversight of execution of all regulatory filling activities across product lifecycles, which may involve performing some of the work of DRA staff. 
Lead contact and negotiation with local Has and internal stakeholders to build and cultivate trusted partnerships.
Ensure regulatory filings are aligned with commercial and supply needs to ensure business continuity significantly influence internal and external stakeholders for successful regulatory outcomes.
Regulatory compliance:
Develop and maintain current knowledge of international and local regulations and other governing regulatory practices, policies, procedures, systems and standards.
Ensure regulatory inspection-readiness for the Affiliate, including leading or participating in internal/external regulatory audits. 
Ensure all Affiliate regulatory activities comply with Roche global standards and local regulations.
Other:
Oversee and guide end-to-end local product packaging and labelling from a regulatory perspective. 
Where applicable, oversee review and approvals of promotional materials to provide regulatory input and guidance across the Affiliate.
As applicable, provide oversight of shipment clearance/QA release of Affiliate materials/products.
Support local access market activities from a regulatory perspective.
Oversee the preparation of regulatory documentation for submission of tender and importation programs. 
Oversee the submission of events to health authorities and timely submission of product specialities dossiers for working authorization.
KEY WORK RELATIONSHIPS:
Internal:
Collaborate with all related departments to reach the affiliate objectives.
External:
Establish and maintain a good relationship with local health authorities. 
ROLE-SPECIFIC REQUIREMENTS:
Qualifications & Experience:
Pharmacy graduation diploma
Written and spoken French.
Able to communicate in English
.
Skills & Abilities:
Several years of working experience in Pharmaceutical company and has a proven ability to work in an international environment. 
Has dealt with internal and external customers
Used to working in a high volume environment handling multiple tasks 
Strong knowledge of software applications (Excel, Word, PowerPoint…)
Mindset and Competencies
Strong organization skills
Good communication skills
Good time and priority management
Strong team player
Open-minded and flexible
Customer service orientated
Entrepreneurial spirit with strong partnership skills 
Growth mindset, coaching, active listening
Ability to learn and self-challenge quickly, take risks and experiment, and contribute to the learning cycle by sharing knowledge with others inside and outside 
Autonomous and altruistic in supporting the global network
High sense of integrity in everything he/she does (ie open, honest, ethical and authentic)
Facilitator leveraging internal and external networks to create value, share and scale.