Director of Regulatory Submissions

About the Position

Director of Regulatory Submissions

Cerca Talent is seeking a Director of Regulatory Submissions to lead our submission process for drug approval in the Pharma and Biopharma marketplace. Our client is an owner-managed, US and Europe-based boutique consulting firm, which accompanies and leads the new product submission process to obtain drug approval for a variety of customers in the Pharma and Biopharma marketplace. US operations are guided from Boston, MA and European operations from Antwerp, Belgium.

Responsibilities

• Facilitate timely and high-quality execution of all submission activities working in close collaboration with regulatory teams and project management.
• Translate regulatory strategy for initial NDA/MAA (and other) submissions into operational assumptions.
• Be in charge of continuous, permanent process improvement and institutionalization of processes for creation and planning of global common technical documents (CTD).
• Drive readiness and execution of identified regulatory submissions within the organization.
• Work with stakeholders at all levels in the organization to ensure awareness of plans, milestones, challenges, and risks.
• Work with line managers in the client organization to solve gaps in existing departmental and cross-departmental processes and organizational structures as it pertains to submission readiness and optimizations.
• Determine capability and operating gaps across the organization as it pertains to submission readiness and submission optimization.
• Drive remediation of major capability or operational gaps.
• Support and guide development teams in finding solutions and implementing improvements in processes and performance, sharing practices and learning about the projects. Leverage learnings by training and communication within the company.
• Ensure effective communication throughout the organization.

Requirements

• A scientific or engineering master's degree.
• Deep knowledge of drug development (ideally data management, statistics, clinical (phase III) development, CMC, or regulatory).
• Direct submission experience (initial NDA/MAA) and a leading role in a submission team.
• Proven project/program management experience.
• The ability to work independently; handling effectively conflicting priorities in a changing cross-departmental and international environment.
• The willingness and drive to operate where the action is, right at the work floor.
• Clear and direct communication style while having strong organizational sensitivity and understanding of culture yet not being intimidated by hierarchy or internal politics.
• Effective communication skills at all functional levels: involvement, active listening, and discreet when needed. Ability to lead complex discussions at all levels of the organization.
• Experience with technology and (IT) tools used to manage complex projects; operational knowledge of MS Office/Outlook, MS Visio/Concept Draw, MS Project, or similar.
• Self-motivating and self-starting characteristics.
• The drive to be accurate, independent, and willing to challenge existing, client process, or way of working and communicating, without being complacent or opinionated.
• The need to be proactive and result-driven while showing the ability to take the next step.
• Proven analytical skills and willingness to apply systematic problem identification and resolution skills and/or tools.
• A proven track record showing the ability to work effectively and conscientiously when under tight schedules and under minimal direct supervision.
• The willingness to work over 90% on-site at our client’s premises in the Greater Boston Area.
• Excellent verbal and written communication skills utilizing high-level business English.

We Offer

• Competitive salary: $100,000 - 120,000 per year (commensurate with experience) plus bonus and benefits.
• Full-time position.
• Opportunity to work in a dynamic and innovative environment.

About the Company

Cerca Talent is a full-service Executive Search Firm with a strategic focus in the areas of Clinical Diagnostics, Clinical Research, Companion Diagnostics, Molecular Diagnostics, and Oncology Practices. Our clients choose to work with CERCA because of our deep understanding of the industries that we serve. They continue to work with us based on our knowledge and contacts which lead to amazing service to our clients.

Location

Boston, MA, United States

Contact

Phone: +12094373846

Email: [email protected]