Cmc Regulatory Affairs Associate

4 months ago

London, United Kingdom Perrigo Full time

**Description Overview**:
As a major player in consumer health and cosmetics, Perrigo is an American pharmaceutical company committed to supporting the health and well-being of consumers through a unique portfolio of market-leading brands such as EllaOne® or Norlevo® (Women’s Health), Compeed® or Mederma® (Skincare), XLS Medical® (Weight Management) or also in many other categories (cough, cold, allergies, natural health ).

We are dedicated to making lives better by bringing Quality, Affordable Self-care products that consumers trust everywhere they are sold.

In our Global Regulatory Affairs CMC team, we’re looking for a new CMC RA Associate who will be in charge to ensure CMC (Chemistry Manufacturing Control) compliance with appropriate global legislation governing Safety Surveillance, Manufacturing and Distribution of products, resulting in no interruption to flow of business or impact on company reputation.

In this role you will work in close partnership with the cross functional team. You will support affiliates regulatory teams to ensure products success and timely delivery

**Scope of the Role**:
As a trusted partner you will be delivering the regulatory actions needed to get products to market and keep them there with optimized positioning versus the business strategy. You will ensure our company are synonymous with world
- class regulatory documentation to ensure regulatory aspects are never a barrier to our commercial goals.

**Main missions**
- Handle the CMC regulatory activities for different site transfer projects and complex CMC projects (new API sourcing, Formula change )
- Deliver the CMC regulatory actions needed to get products to market and keep them there with optimised positioning versus the business strategy. Be a trusted voice in maintenance of our product portfolio.
- Maintain a portfolio where products are often old / geographically separated
- Define CMC Regulatory strategy development to achieve the commercial goals
- Understand and overcome the legal and regulatory interpretation of healthcare product legislation, guidelines, and established practice
- Provide regulatory strategy recommendations to the regulatory leadership team
- Make decisions on project expenditure and project prioritisation, as well as Regulatory executional steps / actions to deliver an agreed strategy

**Experience Required**:
Coming from a life science or scientific background (at least Bachelor/ideally Engineer or Master’s degree), you have at least 3-5 years of experience providing regulatory affairs support to CMC matters and you are familiar with legal framework and forthcoming legislation that will affect the business. A previous experience in R&D or Industrial Affairs is a plus.

**Essential skills**:

- Good Knowledge of pharmaceutical legislation (ICH, EMA guidance ) as well as GMP
- Good level of autonomy
- Critical Thinking and Problem-Solving skills
- Good attention to detail
- An enthusiastic self-starter and team player with a positive and flexible approach to work
- Effective verbal and written communication skills
- Fluency in English mandatory, fluency in French is a plus

Permanent position with a hybrid work model can be based in Dublin (Ireland), London (UK) or Chatillon (France/Paris region).
- At Perrigo we are seeking a diverse applicant pool to ensure the diversity of our team reflects the end consumers we serve through our self-care mission. We are proud to be an equal opportunity employer that celebrates our team’s differences. Individuals of all ethnicities, religious creeds, sexual orientations, genders, ages, mental and physical abilities are encouraged to apply. TOGETHER, we make lives better._

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