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Senior Regulatory Affairs Associate (LCM/MAA)

Parexel International Corporation

Romania - Any Region - Home Based

We are currently looking for a Senior Regulatory Affairs Associate in Romania who will have the following responsibilities: Contribution & providing recommendation in assuring the optimum process of the RA activities development, for (re)registering the products, properly sustaining the local registration activities and maintenance of marketing authorizations (MA), throughout the entire live cycle of medicinal products (Innovative Medicines). Drafts and submits applications for authorizations, for the extension of the existent marketing authorizations, MA transfers – within the agreed deadlines and according to the necessities established at the company level and/or imposed by the legislation. Assures the optimum process of maintaining the products’ MAs throughout their entire live cycle – all allocated portfolio Runs the local process of assuring the commercial packaging compliance for implementing the drug-related information, approved by the local authority, including Patient Information Leaflets and the texts for primary and secondary packages. Manages and coordinates the local activities for improving and assuring the excellence of the global RA processes, in order to assure the local compliance of the registration activities (regulatory) Assures the existence and updated maintenance of Standard Operating Procedures for all registering activities locally developed, in relation to global procedures and the applicable legislation. Assures the accurate and updated nature of the data regarding the status of registration and changes transmitted to the RA department which are applicable to Romania, through global database. Keeps the entire archive of documents which is necessary according to the regulations and procedures, systems and local and global politics, for fulfilling the business requirements. Develops and keeps an adequate and constructive business relation with the global colleagues and those from the local team, for fulfilling the business requirements. Oversight of regulatory requests received from global/regional RA and support provision of relevant regulatory intelligence information. QualificationsIdeal candidate will possess: Very good understanding of performing the above regulatory tasks on local level Regulatory experience from Pharma or CRO is essential Very good Project Management skills Strong organizational and time management skills Strong communication skills Fluent English and Romanian

Job posted: 2021-06-25

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