- We are searching for a well-known pharmaceutical group located in Madrid a CMC Senior RAO Specialist. Our client offers a headquartered position in its international RAO team located in Spain which is registering dossiers (own products and licensed ones) around the world. Direct hire and a permanent contract are offered, interesting opportunities for careers development.
Support new regulatory submissions and assisting with the lifecycle management of the existing portfolio making sure that any variations and/or renewals will be submitted in time to ensure regulatory compliance.
Support global and local groups in preparing module 1 for a new MA applications Prepare eCTD documents under supervision
- Provision of samples and CPPs to the local affiliates
- Archiving of essential documents, such as Product Information and ensure quality part of the dossier are archived and updated in line with company procedure
- Support and provide the necessary documentation to local affiliates for national submissions
- Share essential information from the dossier post approval are shared with local affiliates, QA and PhV according to relevant procedures
- Prepare the necessary documentation needed for submission of administrative variations
- Prepare the necessary documentation needed for submission of quality related variations
- Compile and prepare the necessary documentation needed for submission of safety variations in liaison with pharmacovigilance department
- Submit renewals in timely manner and that timelines are communicated with all partners
- Make sure that the regulatory database is up to date for his/her projects in the region
- Stay up to date on latest regulatory requirements in the region
Inform interested parties, such as commercial, business development and top management on the regulatory status in respective area
- Education: Degree in Health Sciences (preferably Pharmacy, but also Chemistry, Biology, Biochemistry, Veterinary or similar).
- Languages: Fluent Spanish and English, knowledge of other languages will be an asset.
- Experience (years/area): +4 years of experience in the pharmaceutical industry
- Specific Knowledge: Knowledge in Module I - IV Experience in management and team coordination Technical Records. Preferably have previous connection with generic or branded generics (copies). Knowledge of International Standards in terms of drug registration. Experience in centralized and decentralized records. Knowledge of international markets and distribution business is desirable.
- Personal skills: Initiative and proactivity, ability to make decisions autonomously, decisiveness.
Interested candidates must send CV and application letter to firstname.lastname@example.org.
International markets experience either LATAM, MENA, ASIA.... is MANDATORY for the senior profile; European experience would it be enough for the junior profile.