.job descriptionabout this role:the sr.
manager, regulatory affairs is a pivotal role within our dynamic regulatory team, focused on the latin american north (lan) and international growth markets (igm).
in this position, you will spearhead local regulatory activities in mexico and colombia, playing a strategic role in early-stage pipeline development, submissions, and lifecycle management of registered products.
your contributions will be instrumental in clinical, labeling, and cmc strategies, ensuring alignment with regional regulatory frameworks.
reporting directly to the latam regulatory senior director, your expertise will not only drive compliance but also facilitate effective product launches and market presence.
as a central figure, you'll navigate the complex landscape of pharmaceutical legislation, interfacing with key stakeholders to maintain biogen's commitment to excellence and innovation.what you'll do:develop and execute registration strategies in mexico and colombia, aligned with regional business objectives and timelines.forge and enhance relationships with global, regional, and local stakeholders, ensuring effective support and communication.provide insights and strategic guidance on local regulatory matters, influencing the direction of submissions and market approaches.lead regulatory submission activities for new products and manage lifecycle activities for existing products within the region.coordinate and oversee dossier submissions to achieve timely approvals from drug regulatory agencies.ensure regulatory compliance for all marketed products, managing licensing, labeling, and cmc commitments.manage and direct the labeling and artworks development process, ensuring adherence to sops and local regulations.actively monitor and communicate regulatory commitments and changes to key partners and colleagues.maintain up-to-date regulatory intelligence, interpreting local guidelines and anticipating their impact on operations.build and sustain robust relationships with regulatory officials and represent biogen in local industry associations and regulatory forums.provide regulatory input and guidance across corporate functions, fostering a proactive and collaborative environment.who you areyou possess a strategic mindset with an analytical approach to risk assessment and problem-solving.
as an effective communicator, you are fluent in both spanish and english, enabling you to navigate a multilingual landscape with ease.
your track record of fast-track registration and interactions with regulatory authorities like cofepris and invima speaks to your ability to lead and influence in a regulatory context.
with an empathetic and emotionally intelligent nature, you build relationships effortlessly and make decisions collaboratively, even when operating remotely.qualificationsbachelors degree, master's preferred.at least 5 years of experience in regulatory affairs in mexico.
experience incolombia a plus