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Executive Director, Clinical Regulatory Affairs

2 months ago

San Francisco, California, United States BioTalent Canada Full time
About the Position

The Executive Director, Clinical Regulatory Affairs is a key leadership role responsible for developing and implementing global regulatory strategies for clinical development programs to secure and maintain market access for product(s) in line with business objectives.

This role will provide leadership and strategic regulatory oversight for designated projects, ensuring that the latest requirements and standards are met. The incumbent will interface with outside regulatory agencies and business partners in regard to development, regulatory, and registration strategies.

This role will have a dotted line responsibility for regulatory affairs roles in Singapore and Ireland.

Key Responsibilities

  1. Provides high-level strategic and operational regulatory leadership and mentorship on projects, including general regulatory strategies, regulatory requirements for clinical studies and marketing approval in domestic and international markets, regulatory strategic development plans and risk assessments, critical issue management, and advice on Regulatory Agency Interactions.
  2. Builds, grows, and manages a high-functioning team with a focus on staff development and appropriate succession planning. Provides leadership, coaching, and feedback; mentors and empowers personnel.
  3. Uses extensive knowledge of US, EU, APAC, and ICH regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues to support corporate strategy.
  4. Oversees the preparation and submission of documentation to support investigational and marketing registration packages throughout the world and ensures timelines are met.
  5. Reviews sections of IND/CTA, BLA/MAA, and other global submission documents in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements.
  6. Liaises and negotiates with global regulatory authorities as needed for all aspects pertaining to drug development, including resolution of key regulatory issues and to expedite product approvals and labeling.
  7. Maintains awareness of the global regulatory environment and assesses the impact of changes on business and product development programs. Facilitates policy and development of the standard interpretation of global regulation.
  8. Integrates functional expertise with business knowledge to solve problems and make good decisions to support overall corporate business strategy.
  9. Trains, develops, and manages an effective regulatory team both via direct and indirect reporting structure.
  10. Builds partnerships with senior key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge, expertise, and the provision of appropriate resources.
  11. Manages the preparation of operating and personnel budgets and plans. Authorizes expenditures, oversees forecasting activities, and communicates anticipated variances to senior management as required.
  12. Responsible for assisting with the development, implementation, and enforcement of regulatory processes.

Education and Experience

  1. Ph.D. and 12+ years of work experience in pharmaceutical regulatory affairs, or B.S./M.S. and 15+ years of work experience in biotech or pharmaceutical regulatory affairs.
  2. Experience working as a senior leader in Regulatory Affairs across two or more major geographic areas is required.
  3. Demonstrated experience in developing and executing regulatory strategies for oncology products throughout the product lifecycle, from early development to post-marketing activities.
  4. Ability to establish and cultivate strategic partnerships with CROs to optimize regulatory processes and timelines.
  5. A minimum of 5 years of biologics development experience is required.
  6. Proven experience working on BLA (Biologics License Application) processes strongly preferred.
  7. Experience with Antibody-Drug Conjugates (ADCs) or T-cell Engaging Therapies (TCEs) is highly desirable.

Core Competencies, Knowledge, and Skill Requirements:

  1. Proven interpersonal skills with the ability and experience to work collaboratively as a member of a global cross-functional team, working in multiple time zones.
  2. Ability to establish and maintain effective working relationships.
  3. Strong leadership skills with the proven ability to manage, develop, and empower employees.
  4. Thorough understanding of drug development processes and the pharmaceutical industry and healthcare environment, including regulatory requirements and policy trends.
  5. Extensive regulatory experience with INDs/CTAs, BLAs/MAAs, lifecycle management, interactions with Regulatory Agencies, leading and managing regulatory teams, developing and implementing regulatory strategies with a proven track record of significant regulatory accomplishments.
  6. Strong business acumen and ability to make sound decisions that contribute positively to the business strategy or interests.
  7. Very strong strategic skills, including creativity and effectiveness in identifying and addressing major strategic challenges (e.g., new competition, shifting market environment) and the ability to balance short-term needs with long-term vision.
  8. Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism.

Communication & Interpersonal Skills:

  1. Excellent verbal and written skills; able to analyze, define, and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to internal and external stakeholders.
  2. Skilled in conflict resolution/negotiation. Fosters open communication. Listens and facilitates discussion.
  3. Strong negotiating skills and ability to think creatively and develop creative solutions.
  4. Ability to prioritize and handle multiple projects.
  5. Proven ability to build trust and respect within the organization.
  6. Ability to interact with external business partners and Regulatory Agencies.

Total Rewards

We offer a comprehensive total rewards package, which includes competitive salaries, generous benefits, an outstanding work environment, and excellent opportunities for professional growth. We regularly benchmark our compensation against leading biotechnology companies in our geographies.

The US base salary range for this full-time position is $251,000 – $385,000 + bonus + equity + benefits. Our salary ranges are determined by role, level, and location.

The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all US locations. Within the range, individual pay is determined by a variety of factors and the salary offered may vary depending on the successful candidate's location and qualifications (including, but not limited to, job-related knowledge, education, training, skills, and experience).

Please note that the compensation details listed in role postings reflect the base salary only, and do not include bonus, equity, or benefits.

  1. Industry-leading vacation and paid time off
  2. Excellent health and wellness benefits
  3. Zymelife health and wellness benefits
  4. Paid time off to volunteer in your community
  5. Matching country-specific pension savings program
  6. Employee Share Purchase Program
  7. Employee Equity Program

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.