Senior Director of Regulatory Strategy

Discover International; Boston (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Discover International is seeking an experienced Global Regulatory Affairs leader to own regulatory strategy across development and post-marketing programs. You will lead interactions with health authorities, align regional plans, and coach a matrixed team of regulatory professionals to drive timely submissions and informed business decisions.

The ideal candidate brings 12+ years in regulatory affairs, including 5+ years of management, and a deep knowledge of global and regional regulations

Qualifications

• Bachelor’s degree in biology, chemistry, or a related discipline (or equivalent combination of education and experience)
• 12+ years in pharmaceutical or biotech regulatory affairs, including 5+ years of supervisory or management experience
• Expert knowledge of global, regional, and local regulations and guidance for human medicines across development, registration, and maintenance
• A proven record of creating and assessing proposals to regulatory authorities and leading productive health authority interactions
• Experience guiding development teams on refinements to regulatory pathways as outcomes evolve
• Success leading in a matrixed, cross-functional organization
• Strong communication and influencing skills at all levels, in writing and in presentations
• A business-minded, strategic approach and a commitment to coaching, mentoring, and inclusive leadership

Responsibilities

• Build and drive global regulatory strategies for multiple or complex programs, documented in Global Regulatory Strategy Documents
• Lead regulatory submission documents and health authority communications across regions
• Represent Global Regulatory Affairs on core development and project teams, partnering with regional leaders to give unified input into clinical programs and commercial strategy
• Advise senior management on the status of regulatory strategies and tactics, and resolve complex issues with advanced regulatory solutions
• Lead project plans, timelines, and resourcing so priorities are met on time
• Align matrixed, cross-functional teams on regulatory requirements, timelines, and deliverables
• Influence the regulatory environment through conferences, agency and industry meetings, committees, and trade associations
• Track regulations, policy, and competitive intelligence, and adjust strategy ahead of changes
• Lead continuous improvement of department processes
• Lead, coach, and develop regulatory team members, including skill development and performance feedback

Job description

The Role

You will own global regulatory strategy for a set of development and marketed programs, from first-in-human through post-marketing. You’ll be the regulatory voice on core development and project teams and the lead strategist for health authority interactions. Depending on the assignment, your scope may be global, regional, or local.

What You’ll Do

• Build and drive global regulatory strategies for multiple or complex programs, documented in Global Regulatory Strategy Documents
• Lead regulatory submission documents and health authority communications across regions
• Represent Global Regulatory Affairs on core development and project teams, partnering with regional leaders to give unified input into clinical programs and commercial strategy
• Advise senior management on the status of regulatory strategies and tactics, and resolve complex issues with advanced regulatory solutions
• Lead project plans, timelines, and resourcing so priorities are met on time
• Align matrixed, cross-functional teams on regulatory requirements, timelines, and deliverables
• Influence the regulatory environment through conferences, agency and industry meetings, committees, and trade associations
• Track regulations, policy, and competitive intelligence, and adjust strategy ahead of changes
• Lead continuous improvement of department processes
• Lead, coach, and develop regulatory team members, including skill development and performance feedback

What You Bring

• Bachelor’s degree in biology, chemistry, or a related discipline (or equivalent combination of education and experience)
• 12+ years in pharmaceutical or biotech regulatory affairs, including 5+ years of supervisory or management experience
• Expert knowledge of global, regional, and local regulations and guidance for human medicines across development, registration, and maintenance
• A proven record of creating and assessing proposals to regulatory authorities and leading productive health authority interactions
• Experience guiding development teams on refinements to regulatory pathways as outcomes evolve
• Success leading in a matrixed, cross-functional organization
• Strong communication and influencing skills at all levels, in writing and in presentations
• A business-minded, strategic approach and a commitment to coaching, mentoring, and inclusive leadership

Nice to Have

• Experience in emerging disease areas or lifecycle work on registered medicines
• Active participation in industry and agency regulatory forums
• Curiosity about AI and new technology, and sound judgment in applying it to improve decisions and efficiency