Biomedical Research Submission Management, Associate Director

Key Responsibilities:

• Managerial responsibility for local submission management team.
• Manage the preparation of the BR submission components regulatory submission dossiers such as NDA, MAA (i.e., high complexity submissions).
• Leads submission planning discussions, developing, and maintaining a comprehensive strategic submission plan including a detailed list of dossier content, interdependence, key activities, target governance board review time frames, content delivery timelines, credible dispatch dates and executing this plan.
• Provides various data visuals, to facilitate awareness of key milestones, closely monitors critical path activities, and ensures transparency of submission status to stakeholders.
• Provide strategic input relating to submission requirements for migration of submission related supportive documentation for in licensed/joint ventures and acquired assets. Managing the preparation of the subsequent dossier preparation therein.
• May act as deputy for Head BR Submission Management upon request.
• Leads continuous improvement activities related to submission processes and regulatory document management within BR.
• Contribute to the development of key performance indications for the submission management group.
• Maintain the group’s knowledge of evolving submission requirements, ensuring BR is building strategies to proactively prepare the organization for the future.
• Participation in audits and inspections and execution of any resultant corrective action plans.
• May oversee maintenance of specialized expertise on current templates, processes, systems, electronic submission standards regulatory guidelines and legal requirements, as relevant to SM, and training of associates, submission management teams and vendors thereon.

Essential Requirements:

• Undergraduate degree, preferably in a scientific discipline or life science background or equivalent work experience
• 5-10 years’ experience working in a regulated, life science environment (pharmaceutical, biotechnology), with 2-3 years’ experience as people manager.
• Project management experience in the pharmaceutical industry or in a regulatory environment.
• Expert knowledge of Regulatory Affairs responsibilities from pre-IND through Phases I-IV preferred.
• Demonstrated leadership and negotiation skills with ability to persuade and influence others (regardless of level) in achieving team and submission objectives.
• Ability to interpret regulations and gain consensus on a way forward in an environment where there may be more than one way of achieving a successful outcome.
• Effectively lead multidisciplinary team meetings and drive discussions regarding submission content, timelines, resource allocation, risk management, etc.
• Ability to proactively identify and mitigate risks and potential bottlenecks, apply sound judgement when determining if/when to escalate issues, and effectively interact with stake holders to ensure transparency of submission progress/status.

Commitment to Diversity and Inclusion / EEO: The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $132,300.00/year to $245,700/year; however, while salary ranges are effective from 1/1/25 through 12/31/25, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.