Regulatory Affairs, Senior Manager
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
By providing a foundation for all operations company wide, BioMarin’s General and Administrative teams support our mission of providing first and best in class therapeutics to patients who live with rare diseases. Our teams include groups such as finance, legal, human resources, corporate compliance and ethics, and information technology. Come join our team and make a meaningful impact on patients’ lives.
This 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.
- 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.
- Expected to have at least 10+ years of biotechnology or pharmaceutical industry experience including at least 8 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.
- Bachelor’s degree required; life sciences preferred.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.