Associate Director, Regulatory Operations

The role

The Associate Director, Regulatory Operations provides leadership for global regulatory submissions, regulatory information management, and document management. This role leads submission planning and delivery for development and marketed products while managing electronic document management and publishing systems.

What you will do

• Lead and oversee the planning, preparation, formatting, assembly, publishing, quality control, dispatch, and archiving of global regulatory submissions and correspondence
• Coordinate submission deliverables for applications and lifecycle activities
• Provide tactical guidance to global regulatory teams
• Serve as a point of escalation for submission, publishing, document, process, and technology issues
• Maintain complete, traceable, accurate, and readily retrievable regulatory records
• Provide business ownership and operational leadership for assigned RIM and electronic document management capabilities
• Lead and support system governance and administrative processes
• Partner with stakeholders to gather and translate business requirements into system and process solutions
• Partner with IT, Quality, and vendors on system implementations, upgrades, and validation
• Oversee external vendors, consultants, and contractors

Required qualifications

• Bachelor’s degree in scientific discipline or related field or equivalent combination of relevant education and experience
• 8 years of regulatory operations experience within the pharmaceutical or biotech industry
• Strong expertise in the eCTD process
• Oversight of electronic document management systems
• Publishing software and tools expertise
• Technical expertise in EDMS oversight
• Thorough knowledge of US and international regulations as they apply to Regulatory Affairs Operations
• Ability to influence and partner cross-functionally
• Self-organized, self-directing, and highly motivated
• Strong critical thinking and analytical skills
• Excellent verbal and written organizational and communication skills
• Willingness and ability to travel domestically and internationally as needed

Benefits

• Competitive base, bonus, new hire and ongoing equity packages
• Medical, dental, and vision insurance
• Employer-paid life, disability, business travel and EAP coverage
• 401(k) Plan with a fully vested company match 1:1 up to 5%
• Employee Stock Purchase Plan with a 2-year purchase price lock-in
• 15+ vacation days
• 13 -15 paid holidays, including office closure between December 24th and January 1st
• 10 days of paid sick time
• Paid parental leave benefit
• Tuition assistance

About the company

Acadia is committed to turning scientific promise into meaningful innovation for underserved neurological and rare disease communities. Their commercial portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome.