REGULATORY AFFAIRS AND LOCAL QPPV(Embedded Solution)

At Auren Personas we work from the Recruitment & Executive Search division and we are dedicated to providing specialized Human Resources consulting services.

We are currently collaborating with a leading Pharmacy industry company based in Madrid, which is looking to add a Regulatory Affairs and Local QPPV to its team.

About the role

Supervise and coordinate the execution of formulation, manufacture, dossier construction, registration of products. Also supervise the registration of companies, where applicable. Act as the local QPPV

Duties required

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Assist on products registration (human medicines, medical devices, cosmetics, food supplements, etc), variations, renewals, or any other activity regarding the maintenance of the dossiers (e.g., readability tests). These procedures could be National or European procedures (Centralized, Decentralized and Mutual Recognition Procedures).

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Ensure regulations compliance (on both European and local regulations) for all Cipla products.

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eCTD compilation

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Collect and evaluate scientific data.

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Prepare labelling, PIL, SmPC and mockups of medicinal products, and adaptation to current QRDs.

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Provide strategic advice throughout the development of new products.

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Managing teams of colleagues involved with the development of new dossiers.

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Keeping abreast of international legislation, guidelines, and customer practices in all countries that the company is working.

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Advise clients and manufacturers on regulatory requirements.

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Work with specialist computer software and resources (eCTDmanager, Lorenz Validator, RAEFAR, etc).

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Negotiate with regulatory authorities for marketing authorisation, variations, or any other required activity for the approval of client’s medicinal products in Spain and other countries, as needed.

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Submit price & reimbursements procedures for the new products including negotiations with the MOH

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Support the quality team in the local release of the products

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Act as the point of contact for the Pharmacovigilance department, being the local QPPV

Requirements

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At least 3 years in a similar work position.

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B. sc degree in life science (Chemistry, Biology, Pharmacy, etc).

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Master or related course in Regulatory Affairs will be desirable.

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English level: High (spoken and written).

Benefits

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Professional development opportunities in an international environment

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Partial remote work options.

We appreciate your application and interest, we look forward to meeting your talent!

At Auren Selección & Executive Search, we offer a global range of solutions for the identification, recruitment, selection and evaluation of talent.

We provide local and international services for any volume. We have highly specialized teams, more than 20 years of experience and proven success stories.