About This Role
As the Senior Manager, Global Regulatory Affairs, you will join a dynamic team dedicated to navigating regulatory pathways at an above-market level. You will oversee the preparation, submission, and management of key regulatory submissions, together with the EU Regulatory Lead, ensuring compliance with applicable regulations and guidelines. This role requires you to proactively identify potential regulatory risks and develop effective mitigation strategies. By maintaining the highest standards of ethical conduct and integrity, you will ensure compliance with relevant regulatory requirements, company policies, and industry standards. Your contributions will be pivotal in developing or overseeing the overall content and timing of regulatory filings. As a member of the regulatory project team, you will play a crucial role in shaping the future of our projects and supporting the global clinical development and lifecycle. Over time, this role may take a leading role in defining EU strategies and setting the strategic direction for assigned products.
This is a hybrid role, requiring approximately 50% of each week spent in the Biogen offices in Maidenhead, UK.
What You’ll Do
* Collaborate with the Global Regulatory Lead for assigned projects and be a member of the regulatory project team (RPT).
* Work with the EU RL to determine EU regulatory strategies for assigned projects, supporting the global clinical development and lifecycle.
* Identify and assess regulatory risks associated with product development and define strategies to mitigate these risks.
* Support the EU RL to set strategic direction and lead the EU regulatory submission process, including CTAs, PIP, scientific advice, MAAs, variations.
* Support the development of the EU product information and represent EU regulatory strategy at global labeling team meetings.
* Monitor and analyze EMA and national Health Authority activities and assess their specific impact on your projects.
* Foster positive interactions with the EMA.
* Represent the department in EU project teams, committees, and external meetings.
Who You Are
You are an energetic and creative problem solver who thrives in a collaborative environment. Your strong leadership and communication skills enable you to guide and work effectively across various functions and levels of the organization. You possess a strategic mindset and have the foresight to anticipate and address regulatory challenges proactively. You are passionate about maintaining high ethical standards and integrity in all regulatory processes. Your analytical abilities and deep expertise in the current regulatory landscape make you an invaluable asset to any project team.
Required Skills
* Degree in Life Science or related discipline.
* Strong and proven experience within the pharmaceutical/biotechnology industry, including significant experience in Regulatory Affairs Strategy.
* Hands-on experience in preparing major regulatory filings with the EMA.
* Strong leadership and communication skills, with the ability to guide and collaborate effectively across functions and levels of the organization.
* Strategic thinker with the ability to anticipate and mitigate regulatory risks.
* Expertise in the current regulatory landscape and evolving guidance.
* Experience fostering positive interactions with regulatory authorities, such as the EMA.
Biogen is an E-Verify Employer in the United States. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law.
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