Regulatory Affairs CMC Specialist

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

We are looking for a Regulatory Affairs CMC Specialist who has consolidated experience on Chemistry, Manufacturing and Control (CMC) aspects in order to manage the preparation of dossiers for submission to regulatory authorities worldwide.

Key Responsibilities

- Writing and managing technical sections of Module 3 in collaboration with relevant departments/functions

- Assessment of documentary/technical gaps associated with existing products, processes and methods (Gap Analysis)

- Evaluation of technical reports (Process Validation Protocols & Reports, Analytical Methods Validation, AMT, Development Reports, TT)

- Competence on how to translate technical reports into regulatory documents suitable for submission to the Regulatory Authorities

- Assessment of Modules 3 of existing products in order to predict the potential future regulatory impact associated with those products and related variations

- Conduct regulatory assessments for CMC change controls

Required Education

Degree of chemistry, pharmacist or biotechnology

Required Skills and Experience

- The figure sought is a Specialist in the Regulatory CMC sector with an extremely technical cut who has previous business experience (eg manufacturing Compliance, Regulatory CMC).

- 3+ years working experience in CMC regulatory affairs

- The resource must have adequate skills to understand and deal with the "intelligent and targeted" writing of a section of Module 3 in order to place in it the correct information expected by Regulatory Authorities. The resource must know the guidelines governing the CMC sector, such as GMP, ICH Q, EMA Quality guidelines, WHO guidelines and must be able to interpret these guidelines according to the product to be managed.

- Analytical chemistry / CTD / manufacturing environment / medical devices / GMP / ICH – Regulatory guidelines/ Eur. Ph. /technical transfers

Required Behaviours and Competencies

- Positive thinking and behaviour

- Effective presentation and communication skills

- Skilled in time management and able to meet deadlines

- Initiatives and self-motivation abilities

Required Languages

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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