Associate, Regulatory Affairs (Temp Agency)

Who We Are

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

About Worldwide Research And Development

From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.

Summary

Support the Regulatory Affairs department in the preparation, management and maintenance of the technical and regulatory documentation necessary to ensure compliance with the regulatory requirements applicable to the BioMarin products.

Responsabilities

• Support and prepare Health Authority submissions for registered and non-registered products and follow approval process. (MAH/GMP applications, new Marketing Authorization (MA) application, renewal submissions, lifecycle activities etc.)
• Compile all required documents and prepare submission dossiers according to local requirements and make timely applications.
• Conduct the correspondences for all registered/non-registered products and follow up the Health Authority processes.
• Ensure coordination and collaboration with corporate RA Leads to communicate regional strategy for submissions, including potential risks and gating factors, to internal stakeholders located at Headquarters.
• Assist in managing global/local project timelines and planning.
• Ensure the databases are updated on a timely basis.
• Interface with external partners and contractors as needed.
• Perform promotional material review for Middle East & Africa Region.
• Evaluate local regulations/guidance and provide accurate assessments for Middle East & Africa region
  
  

Experience And Education

• Bachelors degree in Pharmacy, Chemistry, Biology
• Minimum 3 – 5 years of Regulatory Affairs experience in a pharmaceutical company,
• Excellent command of English (both written and spoken),
• Strong commitment to compatibility, scientific quality and integrity
• Analytical thinking
• Good communication and teamwork collaboration
• Good detail-capturing skills while working in a fast-moving environment
  
  

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.