Regulatory Strategy Senior Director

Key Duties & Responsibilities
- Leads development of regulatory strategy for multiple and/or complex development projects (from first-in-human to post marketing application stage), including regulatory submission documents and Health Authority communications.
- Represents Regulatory Affairs/GRA on core and project development teams; collaborates with regional leaders to ensure unified regulatory input into clinical programs and commercial strategy.
- Addresses complex regulatory issues with advanced regulatory solutions and guidance to cross-functional teams; aligns communications across teams and counsels senior management on global regulatory strategies/tactics.
- Develops and manages project plans, timelines, and resources to prioritize work and meet key goals on time.
- Influences the regulatory environment through participation in conferences, industry/agency regulatory meetings, committees, and trade associations; stays current on regulations, policy, regulatory intelligence, and competitive issues.
- Leads continuous improvement of department processes and strategies; provides recommendations in area of expertise.
- Leads GRA functional team(s), including skill development, coaching, and performance feedback.
- People management responsibilities; may include financial accountabilities and human resource responsibilities for assigned staff.

Required Knowledge & Skills
- Business-minded, strategic thinker; proposes innovative solutions to regulatory problems.
- Excellent communication skills; influences decisions; liaises internally/externally; communicates effectively in verbal presentations and writing (regulatory strategy plans and submission documents).
- Provides regulatory leadership on cross-functional teams in a matrix environment.
- Deep technical expertise in regulatory affairs science, including advanced knowledge of global/regional/local regulatory frameworks, laws, procedures, and guidance for human pharmaceutical development.
- Advanced proficiency analyzing and interpreting data, protocols, safety reporting, labeling, and other activities across drug development phases.
- Expertise creating/assessing regulatory authority proposals for regulatory paths and clinical plans; leads productive Health Authority interactions with well-organized cross-functional team preparation.
- Ability to assess adequacy of proposed regulatory pathways/strategies and guide teams with recommendations based on ongoing regulatory outcomes.
- Ability to articulate organizational strategic vision and core values; improves quality of internal regulatory policies/programs/initiatives.
- Culturally sensitive leader; embraces diversity; continuously develops staff via feedback, coaching, guidance, and mentoring.

Required Education & Experience
- Bachelor’s degree in Biology, Chemistry, or other related discipline.
- Typically 12 years of relevant pharmaceutical or biotech industry regulatory affairs experience and 5 years of supervisory/management experience (or equivalent combination of education and experience).

Benefits (if part of job description)
- Annual bonus and annual equity awards.
- Medical, dental, and vision benefits; paid time off (including week-long company shutdown in Summer and Winter); educational assistance/student loan repayment; commuting subsidy; matching charitable donations; 401(k).

Application Instructions
- Apply as directed by the posting (no additional application instructions provided in the job description text).