Senior Regulatory Affairs Specialist

JUST ONE, on behalf of its client, a leading company in pharmaceutical products, is seeking a highly motivated:

Responsibilities:

Development and implementation of a successful regulatory strategy for the EU clients.
Submission of new Marketing Authorization, variation and renewal applications for EU countries via MRP, DCP, NP in eCTD format using relevant eCTD software.
Preparation of Module 1 documentation (including Product Information) for all above mentioned applications and responses to Deficiency Letters (DLs).
Liaise closely with EU Regulatory Authorities.
Collaboration with internal and external parties and customers and coordination of all activities required for collection of all necessary information and documentation for compilation of Module 1 and responses to DLs.
Participation in teleconferences and meetings with the Regulatory Authorities, suppliers, clients.
Follow up of applications and maintenance of internal databases.
Monthly reporting to BD department.
Keeping abreast of EU pharmaceutical legislation, guidelines, and practices.
Participation in the training of new RA team members.
Coach, guide and review deliverables of RA Specialists.

Requirements:

Minimum of a BSc Degree in Pharmacy, Chemistry, Biology or another relevant field.
5+ years of relevant experience in the pharmaceutical area.
Being familiar with EU regulatory guidelines.
Excellent communication in English language (writing & speaking).
Computer literacy.
Problem-solving and organizational skills.
Multi-tasking.
Time management.
Ability to prioritize work and meet deadlines.
Excellent communication and interpersonal skills.

Benefits:

JUSTONE