Regulatory Affairs Manager

What does a Regulatory Affairs Manager do?

As a Regulatory Affairs Manager within Regulatory Affairs, you perform a crucial role in the correct registration of new or updated products, and maintaining the registration of those already on the market. Management of the registration procedure means you collaborate with the relevant authorities, as well as different departments within the organisation. Advertising, promotional material and packing/labelling texts must also be compliant, and you assess the medical and scientific correctness when writing such text. The Regulatory Affairs Manager must keep up to date with legislation and guidelines that apply to the organisation’s products, and you take any necessary action to ensure that registrations are in place or updated.

Take a look at the Regulatory Affairs Manager vacancies to see which are the best fit for you!

What tasks and responsibilities can you expect as a Regulatory Affairs Manager?

As a Regulatory Affairs Manager your tasks and responsibilities will vary according to the size of the organisation and the department, and whether you have a team to assist you. However, they are likely to include some or all of the following:

• contributing to the organisation’s strategic plan and annual plans, in areas such as quality and risk management, regarding registration matters;
• drafting and updating supplementary protection certificates (SPC) text, including text for product information leaflets and labels for medicines in accordance with the regulatory and code of conduct requirements;
• writing and periodically updating drug regulatory affairs (DRA)-related local SOPs;
• reviewing draft registration files and submitting new and amended registration dossiers to obtain and maintain registration;
• providing input as required, for example on technical matters, for the investigational medicinal product dossier (IMPD);
• ensuring that quality standards are met, and all submissions meet agreed deadlines;
• maintaining contacts and sharing relevant information with stakeholders, internally and externally, including liaising with regulatory authorities;
• preparing and participating in presentations on regulatory affairs matters, and providing advice to manufacturers and scientists;
• submitting periodic reports, such as safety update reports to the Medicines Evaluation Board (MEB).

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What education and skills do you need as a Regulatory Affairs Manager?

Education requirements will vary according to the role and the employer, but you will need a degree in a biomedical area and preferably be a qualified pharmacist. You will need a minimum two years’ experience in the field; more (four plus) will be an advantage.
Required skills on top of this are likely to include the following:

• advanced computer skills;
• an analytical and problem-solving mindset;
• excellent organisation and time management skills;
• confident in giving presentations and negotiating;
• good communication skills in Dutch and English, written and spoken.

What salary can you expect as a Regulatory Affairs Manager?

Terms of employment and salary for a Regulatory Affairs Manager are variable and depend on experience. The salary in the Netherlands is usually in the range of €68,000,- – €122,000,- per annum, plus bonus.

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