The mission of Global Regulatory Affairs is building bridges between science and worldwide
regulatory authorities to deliver affordable biosimilar medicines. Every team member has the
goals of providing best-in-class regulatory guidance and advice, de-risking through sound
but innovative regulatory strategy, and submitting quality regulatory documents in support of
product development, licensure, and continued maintenance on the market.
This position of Senior Regulatory Manager in Strategy will act as Global Regulatory Lead in
all aspects of regulatory product strategy and submission worldwide for the assigned
projects.
Key Responsibilities:
• Oversee all regulatory strategic aspects for the development and compliance activities of
assigned project(s).
• Assist in developing the global regulatory strategy for biosimilar development, licensure,
and lifecycle management.
• Represent GRA Strategy on project teams and cross-functional initiatives, providing aligned
regulatory advice and real-time project regulatory status.
• Ensure “One-Voice” from GRA on product strategy and deliver consistent, unified
regulatory messaging at interdisciplinary forums.
• Identify regulatory risks and develop mitigation strategies, escalating to leadership as
appropriate.
• Manage, compile, author, and/or review global regulatory submissions including INDs,
CTAs, IMPDs, MAAs, BLAs, briefing packages, and responses to health authorities.
• Lead and support health authority interactions and response strategy.
• Interface and represent GRA with/to both internal (e.g., Quality, Supply Chain) and external
partners, ensuring dossier alignment and global readiness for commercial success.
• Perform key activities to maintain momentum and adherence to timelines on assigned
projects.
• Foster an efficient, transparent, and collaborative work environment within GRA.
• Maintain continuous professional development to remain current with global regulatory
requirements and proactively share insights with the broader team.
• Complete other tasks as delegated or required by GRA senior management in line with
business needs.Minimum Education and Experience Requirements:
• PhD + 5 years, MSc (or equivalent) + 7 years, or BSc (or equivalent) + 10 years of
experience in Regulatory Affairs or related functions within the
Pharmaceutical/Biotechnology industry.
• Broad regulatory experience with core expertise in biologics, particularly for US and EU
development and submission pathways.
• Demonstrated regulatory authoring expertise with a hands-on approach to preparing key
regulatory documents.
• Fluency in English with excellent verbal and written communication skills.
• Proven ability to collaborate effectively across diverse, global teams.
• Strong organizational skills with the ability to manage multiple priorities across various
projects.
• High attention to detail and regulatory rigor.
• Prior experience engaging with health authorities during development and registration.
Preferred Education and Experience:
• Direct experience managing successful MAA/BLA submissions and approvals.
• Expertise in global dossier authoring and regulatory strategy for biologics and biosimilars
(EMA/FDA).
