Regulatory Affairs Consultant

Job content

Do you ensure registration of new medicines and do you maintain existing registrations of medicines? And are you aware of the latest developments in the market in the field of regulations? Then this is your perfect job.

Overig

Noord-Brabant

32 - 40 uur per week

Good salary

Solliciteer nu

• Over de functie
  

As a Regulatory Affairs Consultant you analyze information and evaluate results to choose the best solution and solve problems. You provide expert advice and guide management on technical regulatory topics. You help other team members to improve their knowledge or skills and you stay informed of the latest developments in the market.

You communicate with customers and provide regular updates. You participate in interdisciplinary project teams and communicate with your colleagues to guarantee high quality. You define the registration strategy worldwide and prepare and service registration dossiers.

Your five most important tasks

• You ensure submissions comply with applicable regulations and guidance documents;
• You formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced;
• You are improving internal processes to reduce risk;
• You establishing objectives and specifying the strategies and actions to achieve them;
• You evaluate information to determine compliance with standards, guidelines and regulations (e.g. ICH, GMP, ISO 9001, MDR/IVDR)
  

As a Senior you will coach new hires specializing in a regulatory area.

Functie-eisen

You are able to work both alone and as part of a team. You are also innovative, flexible and collaborative. You have attention to detail and you have effective problem solving making skills. You have the ability to focus on reading large (electronic) documents and assessing the impact of changes across the file., The company offers you the opportunity to develop yourself within an innovative and international environment. There are great career opportunities and personal growth is central.

You can expect the following

• A competitive monthly salary, depending on your (work) experience;
• Opportunities to develop yourself within an ambitious company;
• A company laptop;
• A cell phone;
• 30 vacation days on a full-time base;
• A monthly amount to arrange your own pension;
• Flexible working hours and hybrid workplaces;
• Personal attention for you and your development
  

Over het bedrijf

The company was founded in May 2014. The company started with one employee, the founder. Nowadays the team has grown to about 20 employees and has a valuable network of specialized experts. They work with (bio)pharmaceutical and medical device companies worldwide to ensure legal requirements are met and business objectives such as rapid market access and compliance are achieved. Consistency and quality guarantee are the most important drivers of the company.

• You have a BSc degree in life sciences, biopharmaceuticals, chemistry of chemical engineering. For the Senior position, someone with a PhD is preferred;
• You have several years of relevant experience in the human or veterinary pharmaceutical industry, in a registration department/quality department of a company in the medical equipment or diagnostics;
• Preferably you have international experience (e.g. MAA, NDA/BLA, JNDA, etc.) with regulatory filing;
• You are familiar with working according to quality management systems;
• You have good organizational and communication skills;
• You have strong oral and written communication skills in English;
• You have the opportunity to proactively improve quality management systems.
  

As a Senior you can work independently on projects and manage projects to achieve, develop and realize high productivity.