Regulatory Affairs Professional
Há 1 mês
Are you an EU Market Regulatory Affairs expert looking for a new challenge in the pharmaceutical sector? We have a fantastic opportunity for you
Key Responsibilities:
- Handling of all post-approval activities related to ANDAs, MAAs, ANDSs, variations/supplements, Annual Reports and deficiency letters according to regulatory guidelines;
- Evaluate Change Controls, issue/update NRP's, prepare product information variations/labelling supplements, provide information for APRs, creation and revision of internal SOPs and DHFs;
- Support the site on the launch of new products by performing all regulatory activities required;
- Prepare, review and implement labelling;
- Comply with defined KPls;
Requirements:
- Master's degree in Pharmaceutical Sciences (Minimum);
- Experienced in EU Market Regulatory Affairs (Preferred);
- 4-6 years of professional experience;
- Responsibility, proactivity and team work;
- Maintains awareness of regulatory guidelines and updates;
- Organization and planning capabilities;
- Ability to work under pressure and meet deadlines;
- Good analytical and negotiation skills;
Offer:
- Direct contract with Client;
- Salary adequate to the function and experience;
- Life insurance;
- Health insurance;
- Annual Performance Bonus;
We believe in Talent without labels, and we are committed to non-discrimination, promoting diversity, inclusion and equity in the workplace.
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