Regulatory Affairs Manager – Consumer Health
- 6 months external contract -
YOUR TASKS AND RESPONSIBILITIES
Ensure local Regulatory compliance by:
• Preparing high quality applications of:
- labeling changes based on the CCDS according to SOP;
- quality related changes according to the agreed timeliness;
- applications for new Marketing Authorization, line extensions and new indications;
- renewals in order to keep Marketing Authorizations valid in the county;
- high quality translations of Product Information for Nationally and MRP-DCP approved products;
- advertising and promotional materials developed by Marketing Department;
- other documents and information as required;
and submitting them to the local authorities according to the national and European requirements.
• Ensure notification of medical devices, food supplements and cosmetics, in accordance with the Romanian law:
- compiles the necessary documentation;
- provides submission of necessary documents to the relevant Health Authorities to achieve notification;
- acts as a contact person for the relevant local Health Authorities.
• Regularly Monitoring the progress of applications and communicates with the authorities in order to obtain timely approvals. Contributes to the preparation of answers to deficiency letters and other Authority requests in cooperation with Global Regulatory Affairs, documenting all relevant contacts in a factual manner, checking of incoming documents and initiating their correction, if needed;
• Timely and complete update of internal and external databases and document management systems, providing relevant information on RA milestones to the other functions on the local and global level;
• Timely implementation of approved labeling and CMC changes into the packaging materials according to SOP and the local legislation, and working together with other stakeholder, . local Quality and Product supply, as appropriate.
• Preparation of local promotional materials in alignment with local marketing, and notification of promotional materials to the relevant Health Authorities in accordance with the Romanian law.
• Archiving of all documents and correspondence submitted to and received from the Authority according to the Global SOP and locally agreed processes;
• Regularly informs about changes in national legislation, changes which are related to Romanian registered products.
WHO YOU ARE
• PROFESSIONAL EXPERIENCE: 1- 3 years’ experience in Regulatory Affairs is a must. Experience with various registration categories (OTC, food supplements, medical devices, cosmetics) is an advantage
• EDUCATION: University Degree in Life Sciences, Medicine (MD) or Pharmacy is an advantage;
• PERSONAL QUALIFICATIONS:
- Team player;
- Able to work independently;
- Requires adequate communication, interpersonal and influencing skills;
- Good command of Romanian & English language
- Computer literate
• Dynamic and involving job;
• Opportunities for training and development;
• Company benefits package;
• Fixed monthly salary.
Application time: until 29 November 2019
Reference Code:CH_ RA Manager
Confidentiality is guaranteed! Only short listed candidates will be contacted!
Deadline for submitting applications: 29 November 2019