Head of Regulatory Affairs Strategy, Global RA

With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical force, listed on the Italian stock exchange, with over 4,300 employees.

We are a group of like-minded, passionate individuals who go to extraordinary lengths for our partners, customers, investors and the people across the globe who we serve. We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries.

At Recordati, our mantra is simple. We’ve always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege. Whether that is for common diseases or the rarest – we want to give people the opportunity to be the best version of themselves.

This drive will never stop. Together, we will always be reimagining tomorrow – with new ideas, new technologies and new innovations to fight diseases.

Recordati. Unlocking the full potential of life.

JOB FUNCTION

Leads the RA Strategic Operations function within RRD Global Regulatory Affairs reporting into the Global Head of Regulatory Affairs. Provides strategic and operational leadership to support portfolio of investigational and marketed products for local and global filings. Responsible for assuring development and execution of regulatory strategies for small molecule, biologic and/or combination products in the US, EU and other territories world-wide. Critical to this role are strong organisational and leadership skills.

DUTIES AND RESPONSIBILITIES

• Leads a team of global regulatory professionals for development and marketed products for All RRD products. Accountable for ensuring that corporate goals are met. Manages the preparation and assignment of RA strategies. Key internal leader and driver of regulatory policy and strategy for assigned products.
• Leads preparation of global, US and Canadian regulatory product strategies (Reg Line Plans) for assigned products. Works with GRL in the preparation and maintenance of risk assessment and mitigation strategy development for assigned products.
• Under the direction of a GRL/TA Head. May participate in or lead initiatives. Based on experience and scientific strengths, expands TA knowledge of TA; provides coaching and mentoring for RA team members.
• May have direct report and contributes to the performance management for other RA team members. Influences the development of regulations and guidance. Advises management of the effect of current or proposed laws, regulations, guidelines and standards, etc.
• Advises team and drives company policies and procedures for regulatory record keeping and may develop and implement policies and procedures within the RA department and , if applicable, ensures direct reports follow requirements.
• Ensures alignment of global regulatory strategies with Sr. Management. Proactively informs Franchises Head and management of issues, risks and mitigations. Provides assessment of impact on global, US and Canadian programs. Provides informed regulatory opinion based on experience and expertise.
• Under supervision of a Global Head of RA, communicates to regulatory team and cross-functionally the immediate to long-range plans to carry out objectives established by executive management.
• Supports PM to make decisions regarding work processes or operational plans and schedules in order to achieve the program objectives established by senior management.
• Advances the organization’s goals by participating and taking leadership roles in professional associations, industry and trade groups as appropriate for assigned projects.
• Follows budget allocations and keeps supervisor informed on project resourcing
• Interprets RA intelligence with analysis of complex regulatory guidance documents, regulations, or directives that impact RRD. Advise personnel in other departments regarding their applicability and impact.
• Provides guidance and standardized process on RA templates and submission documents
• Leads team to review all RA submissions to ensure consistency and high-quality dossiers
• Performs other duties as assigned

EDUCATION & EXPERIENCE

Required Education:

• Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject.
• Preferred 10+ years regulatory experience.
• Some portion may include experience related to pharmaceutical regulatory work (e.g., other R&D role or specialized training).
• Requires drug development experience in NA/EMA region.
• High knowledge of industry trends and comprehensive overview of preparing regulatory documents.
• Proven 3-5 years in a leadership role with strong management skills.
• Experience working in a complex and matrix environment with multiple stakeholders and on cross-functional teams.
• Strong understanding of pharmaceutical development, the regulatory environment, project management, and medical terminology.
• Prior supervisory experience.
• Have a solution-oriented approach to problem solving

Required Experience:

• Strong communication and proactive negotiation skills.
• Experience contributing to corporate management of a portfolio of products.
• Experience interfacing with government regulatory agencies.
• Experience developing and implementing successful global regulatory strategies.
• Strong clinical foundation preferred with business acumen.

ABILITIES, TOOLS AND TECHNOLOGIES

• Fluent in English
• Proactive strategic thinker; Operationally minded (know how to prepare a high quality technical document or submission using internal systems)
• Cross functional leadership skills
• Strong organizational and negotiation skills.
• Strong collaborative inter-personal, communication, presentation and meeting leading skills.
• Strong ability to work in a matrix environment and across cultural lines.
• Computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook)
• Buying into the Recordati Rare Diseases/Recordati identity

At Recordati we believe in people! Inspired by our purpose - unlocking the full potential of life - we are committed to creating a diverse environment and cultivating a culture of inclusion. We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential.

We are proud to be an equal opportunity employer. We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief.

If you are looking to join a company where you can try new things, speak openly, and be bold, we invite you to apply today.

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