Head of Regulatory Strategy & CMC

With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical company, listed on the Italian stock exchange, with over 4,500 employees and turnover of over Euro 2bn.

We are a group of like-minded, passionate individuals who go to extraordinary lengths for our patients, customers, partners, 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 Purpose

The Head of Regulatory Strategy and CMC (Chemistry, Manufacturing, and Controls) plays a crucial role in overseeing the regulatory strategy and CMC activities for pharmaceutical or biotechnology products. This position involves leading a team and collaborating with cross-functional teams to ensure compliance with regulatory requirements, develop regulatory strategies, and manage CMC activities such as product development, manufacturing, and quality control. Key responsibilities may include drafting regulatory submissions, providing strategic input on regulatory matters, maintaining awareness of regulatory changes, and liaising with regulatory authorities. Strong leadership, regulatory expertise, and a deep understanding of CMC processes are essential for success in this role.

Key Responsibilities

• Leading and managing a team responsible for regulatory strategy and CMC activities.
• Developing and implementing regulatory strategies for product development and registration in compliance with global regulatory requirements.
• Overseeing and ensuring the quality and compliance of CMC activities, including manufacturing, process development, and quality control.
• Collaborating with cross-functional teams to provide regulatory guidance and support throughout the product lifecycle.
• Reviewing and approving regulatory submissions, including investigational new drug applications (INDs), new drug applications (NDAs), and marketing authorization applications (MAAs).
• Advances the organization’s goals by participating and taking leadership roles in professional associations, industry and trade groups as appropriate for assigned projects.
• 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.

Required Education

Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject.

Required Skills and Experience

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 5-8 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.

Required Behaviours and Competencies

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.

Required Languages

English, written and spoken.

Travel required in %

30%

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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