Sr. Director, Regulatory Operations/Digital

Job description:

Scope Of The Role

The dynamic and experienced Head of Regulatory Operations (Digital) will shape and lead an effective regulatory information, submission management, and Regulatory Operations organization, including people, processes, and systems, for all development programs and marketed products.

In addition, the Head of Regulatory Operations will be accountable in partnership with R&D QA for Quality Management, Compliance, and process improvement of Global Regulatory Science (GRS) department. The Head of Regulatory Operations will support the overall Head of GRS with the operational management of the department

The ideal candidate will possess deep knowledge of US and Europe submission regulations, guidelines, and practices. The individual will have strong leadership competencies and strategic operational perspectives to ensure optimal use of information to support regulatory, development, supply chain, and product release decisions.

Your Role

• Lead and develop a team of regulatory information and submission management professionals, driving excellence in matrix teamwork and excellence in delivery.
• Lead and oversee quality management, compliance and continuous improvement of regulatory processes and systems for Reg Ops / Digital and GRS in partnership with R&D QA.
• Be the business owner of all regulatory systems, including but not limited to, Veeva Vault RIM and associated business processes and procedures.
• Develop, implement, and maintain a data strategy for capturing and mining regulatory information and data, including but not limited to IDMP.
• Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team
• Drive the spirit of “ONE Team” across all functions by supporting a team approach to focus on our patients as our top priority

Travel up to 20% may be required, which may include overnight and/or weekend travel

Who are you

• 10+ years of relevant experience in the pharmaceutical/biotech industry.
• 5+ years of which in operational and/or systems roles.
• Experience capturing, managing, curating and dashboarding complex data.
• In-depth knowledge and experience in regulatory eCTD submission planning, publishing, and submission.
• Advanced experience with regulatory information management, document management, and associated software and tools.
• Experience in systems / process change management.
• Leadership experience with direct reports and matrix organizations highly preferred.
• Experience across different sized organizations (pharma, biotech, CRO) preferred.
• Experience working with vendors.
• Ability to identify problems, raise them constructively and work towards finding effective solutions.
• Collaborative team player who works effectively with safety, quality, medical affairs, commercial and other functional leaders.
• Proven ability to be hands-on, agile and lead organizational efforts and innovation by example.
• Strong verbal, written, and technical communication skills.
• Learning agility and ‘scalability’ to take on increasing responsibility as Alfasigma grows.
• Consistent demonstration and embodiment of our company core beliefs: Passion for Innovation; Think Big, Act Small; Learn to Dare; Team Build the Future
• Ability to have fun and thrive in a growing, diverse, and inclusive work environment.