Regulatory Affairs Officer

Lavipharm is seeking for a Regulatory Affairs Officer, referring to the Lead Regulatory Affairs.

The role is accountable for ensuring that all products meet legislative requirements. Key duties of the job include studying legislation, gathering, evaluating, organizing, managing and collating information necessary for the registration and marketing of different type of products, like pharmaceuticals and medical devices.

Responsibilities

• Ensures that the company's products comply with the regulations of the regions where marketed

• Keeps up to date with national and international legislation, guidelines and customer practices

• Prepares documentation for different categories of regulatory submissions (dossier registration, renewals, variations) and handles the relevant submissions

• Monitors and sets timelines for license variations and renewal approvals

• Prepares and reviews packaging materials for product launch and/or compliance with legislation and guidelines, for different type of products.

• Ensures the timely preparation of the new/updated artworks

• Provides support for promotional material when required

• Participates in regulatory compliance review projects/inspections

• Reviews company practices and provides advice on changes to systems

• Liaises with the regulatory authorities

• Ensures the maintenance of regulatory databases and departmental filing systems to facilitate accurate and retrievable records of department activities

• Works with specialist computer software and resources

• Ensures compliance with company’s policies and procedures

• Prepares and submits to Authorities any application needed for the importing/exporting of the pharmaceutical products/raw materials

• BA/BS degree in a life science is required

• 1-2 years Regulatory Affairs experience in a pharmaceutical company

• Excellent Knowledge of the English language

• Computer literacy

• Good knowledge of Local, EU and International regulatory affairs legislation and guidance

Skills

• Good organizational & administrative skills, precision and attention to detail

• Good written communication skills with attention to detail

• Team working skills

• Able to work under pressure and to strict deadlines

• Strong critical thinking & ability of data interpretation

If you are ready to embark into challenging endeavors, be exposed to continuous learning opportunities, you are interested in the above position and only if you have the required qualifications, please reply, enclosing your curriculum vitae.