Regulatory Affairs Manager (Zona Norte)
Work in collaboration with key LatAm functional areas
Develop Regulatory filing strategies and identify risks and gating factors
Sobre nuestro cliente
An important American company with high potential in biotechnological business
Descripción de la oferta
The major responsabilities of the job are:
- Work in collaboration with key LatAm functional areas (Commercial, Med affairs, Legal/Compliance, Finance, HR) ensuring that RA strategies are aligned with BMRN´s commercial objectives;
- Manage the planning and preparation of complex submissions including but not limited to the following: Marketing Application (including content development, assembly of the dossier, submission, through approval); post-marketing maintenance including partial change applications, clinical and nonclinical updates are prepared in accordance with Argentine regulations. Interface closely with U.S. and other global its offices to align strategies;
- Develop Argentina Regulatory filing strategies and identify risks and potential gating factors. Evaluate regulations/guidances and participate in industry trade organizations in order to advise the company on the Argentine Regulatory environment and changes that could affect the company's products or plans. Prepare regulatory intelligence reports to communicate any changes or updates on regulations to internal teams;
- Serve as primary liaison with the Regulatory authorities (e.g., ANMAT) and interface on behalf of the company to negotiate as needed to support plans for new drug registrations and activities for existing product licenses. Assist in preparation for and execution of Agency meetings;
- Manage Argentina product licenses and lifecycle, including maintaining as current the administrative, clinical, CMC, and nonclinical sections;
- Work closely to the Argentine Company chosen to represent the copany before ANMAT.
- Identify and manage local Argentine regulatory consultants and contractors, and liaise with them as needed for projects.
- Actively participate in multi-functional global team environment, and clearly communicate RA activities to regional office and headquarters to ensure strategic alignment
Page Group Argentina is acting as an Employment Agency in relation to this vacancy.
Perfil buscado (Hombre / Mujer)
We are aiming to find a BA/BS degree with at least 8+ years of biotechnology or pharmaceutical industry experience including at least 6 years of experience in Regulatory Affairs. Required demonstrated in-depth knowledge and understanding of the Argentine Regulatory environment and proven experience negotiating with ANMAT regarding product registrations, orphan drugs, in-country testing requirements and other regulatory topics.
Proven track record for preparing, submitting, and gaining approvals for Argentina MAs and post-marketing variations, particularly for biologics and/or orphan disease products.
Proven ability to manage major regulatory submissions independently and prioritize multiple projects with competing timelines is required. Must possess a thorough understanding of relevant drug development and post-marketing regulations and guidelines.
The candidate must possess excellent written and verbal communication skills in order to successfully liaise with and influence internal/external stakeholders, and communicate critical aspects of ongoing project activities while demonstrating awareness of global program priorities and competing timelines.
Must be fluent in Spanish and English both verbal and written (technical)
- Attractive compensation package;
- Car allowance