Job description
Job Description
About 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 Are
You 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.
Qualifications
- Bachelors Degree, Master’s preferred.
- At least 5 years of experience in Regulatory Affairs in Mexico. Experience in Colombia a plus.
- Health-related sciences background.
- In-depth knowledge of Mexican pharmaceutical legislation.
- Proven ability to interpret local regulations and influence operations accordingly.
- Track record of achieving fast-track registration in Mexico and Colombia.
- Experience with regulatory authorities (COFEPRIS and INVIMA) and effective interactions with regulatory agencies and corporate partners.
- Rapid assimilation of new knowledge and understanding of cross-functional drug development processes.
- Strong analytical skills, with a focus on accuracy and reliability.
- Demonstrated strategic thinking and risk assessment capabilities.
- Fluent in Spanish and English (required).
Preferred Skills:
- Experience in additional LATAM markets.
- Demonstrated leadership and interpersonal skills.
- High emotional intelligence and a collaborative decision-making approach.
- Exceptional organizational and project management skills.
- Effective presentation skills and confidence in communication.
Additional Information
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
