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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. SUMMARYThis position will be responsible for managing and implementing the strategy, preparation and execution of regulatory submissions, marketing applications (MAs) and post-marketing maintenance) for biologics and synthetic drugs in Colombia, México, Peru, Ecuador and Central America countries (Panamá, Costa Rica, El Salvador, Guatemala, Dominican Republic), and interfacing with regulatory authorities in these countries.This role also involves representing BioMarin at Industry Trade Associations in Colombia, Mexico, Peru, Ecuador and Central America Countries and being part of Regulatory Groups/discussions.
RESPONSABILITIES
- Work in collaboration with key LATAM functional areas (Commercial, Medical Affairs, Legal/Compliance, Finance, HR) ensuring that regulatory strategies are aligned with BMRN´s commercial objectives.
- Manage the planning and preparation of complex submissions including but not limited to the following: Marketing Applications (including content development, assembly of the dossier, submission, through approval); post-marketing maintenance including variations, clinical and nonclinical updates ensuring that the submissions are prepared in accordance with regulations for the countries listed above. Interface closely with U.S. and other global BioMarin offices to align strategies.
- Develop Regulatory filing strategies and identify risks and potential gating factors for the listed countries. Evaluate regulations/guidances and participate in industry trade organizations in order to advise BioMarin on the Regulatory environment and changes that could affect BioMarin's products or plans.
- Serve as primary liaison with the Regulatory authorities (e.g., Invima, Cofepris, Digemid, ARCSA, and Central America agencies) and interface on behalf of BioMarin 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 Colombia, Mexico, Ecuador, Peru and Central America countries product licenses and lifecycle, including maintaining the administrative, clinical, CMC, and nonclinical sections.
- Identify and manage local regulatory consultants and contractors and liaise with them as needed for projects.
- Actively participate in multi-functional global team environment, and clearly communicate regulatory activities to regional office and headquarters to ensure strategic alignment.
- Up to 30% travel expected within North LATAM and to Brazil and US.
EDUCATION AND EXPERIENCE
- BA/BS degree, life sciences preferred.
- Expected to have at least 5+ years of biotechnology or pharmaceutical industry experience including at least 3 years of experience in Regulatory Affairs. Required demonstrated in-depth knowledge and understanding of the regulatory environment in North LATAM.
- Proven track record for preparing, submitting, and gaining approvals marketing applications for Colombia, Mexico, Peru, Ecuador and Central America countries and post-marketing variations, for biologics and synthetic drugs as well as 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.
- 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.
- Experience negotiating with INVIMA, Cofepris, Digemid, ARSCA and Central America agencies regarding product registrations, orphan drugs, in-country testing requirements and other regulatory topics.
- Must be fluent in Spanish and English, both verbal and written (technical)
- Proficiency with computer and standard office software programs is required
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. #J-18808-Ljbffr