Sr. Regulatory Affairs Manager

Katalyst CRO; Boston (MA); On-site; USD 120,000 - 190,000; Full time

Job summary

A leading clinical research organization in Boston is seeking a Regulatory Manager with extensive regulatory experience for clinical trials. The role involves providing regulatory strategy, preparing submissions, and ensuring compliance with regulations. Ideal candidates have 7 years of experience, a scientific degree, and strong communication skills. This position offers a contract employment type at a mid-senior level within the pharmaceutical manufacturing industry, with opportunities for professional growth.

Qualifications

• 7 years of regulatory experience required.
• Experience working for a Clinical Research Organisation.
• Knowledge of drug development process.
• Knowledge of EU and US regulatory processes including IND/CTA, scientific advice, and post-approval submissions.
• Strong project management and interpersonal skills.

Responsibilities

• Provide regulatory strategy for clinical trials.
• Prepare regulatory documents for submission.
• Guide the project team on regulatory compliance.
• Lead regional or global projects and supervise Regulatory Affairs staff.
• Represent Global Regulatory Affairs at project teams and with stakeholders.
• Ensure timely, compliant submissions and travel as needed.
• Drive process improvements and data collection with high-quality outputs.

Skills

Regulatory strategy

Clinical trial knowledge

Interpersonal skills

Project management

Communication skills

Education

Bachelor's degree in a scientific or healthcare discipline

Job description

Responsibilities

• The Regulatory Manager (RM) provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures, ensuring timely preparation of well organized, quality regulatory submissions in compliance with applicable regulations.
• The RM coordinates and prepares regulatory documents for submission to Regulatory Authorities and/or Ethics Committees, as applicable.
• The RM maintains current knowledge of regulations and guidance documents, providing analysis to project teams, as well as supporting and enhancing Precision for Medicines corporate Regulatory function.
• Provides regulatory guidance throughout the clinical development life cycle.
• Compiles, coordinates and reviews applications to Regulatory Authorities including CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications.
• Also provides strategic regulatory input as required.
• Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards.
• Serves as representative of Global Regulatory Affairs at project team meetings with both external and internal customers.
• Works within a project team, and where necessary, leads project for the region or globally.
• Oversees and coordinates Regulatory Affairs Specialists to achieve submission targets for contracted programs.
• Maintains project plans, trackers and regulatory intelligence tools, and keeps Regulatory Leadership updated.
• Assists in development of Regulatory Affairs Specialists and other operational staff, as required.
• Provides input into regulatory strategy and timeline development for new study opportunities, assisting in establishing company standards to ensure the highest quality of submitted information.
• Participates in maintaining and executing on corporate quality initiatives across business units within clinical solutions.
• Keeps abreast and continually expands knowledge of laws, regulations and guidelines governing drug development and approval.
• Provides ICH GCP guidance, advice and training to internal and external clients.
• Serves as representative of Global Regulatory Affairs at business development meetings.
• Understands clinical and pre-clinical study results, helping interpret them for regulatory positions and strategy.
• Has knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development.
• Available for domestic and international travel including overnight stays.
• Motivates other members of the project team to meet timelines and project goals.
• Flexible attitude with respect to work assignments and new learning.
• Resolves project related problems and prioritizes workload to meet deadlines with little support from management.
• Focuses on continuous improvement, proactively assessing how to make processes more efficient and people more effective.
• Collects data of consistently high standard.
• Communicates effectively in the English language both verbally and in written form.
• Conducts formal presentations to a wide variety of audiences with a high level of proficiency.

Requirements

• Bachelor's degree, or equivalent experience, ideally in a scientific or healthcare discipline.
• 7 years regulatory experience required for the Senior Manager Regulatory level.
• Candidates must have regulatory affairs experience working for a Clinical Research Organisation and experience leading Clinical Submissions.
• Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones and specialized knowledge of regulatory activities for at least one major region (EU, US) including submissions to Regulatory Authorities, INDs/CTAs, amendments, Scientific Advice Procedures, and post-approval submissions.
• Knowledgeable of clinical trials methodology, including a working knowledge of protocols and indications being studied.
• Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands stemming from multifaceted research activities.
• Demonstrates an acceptable degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates.
• Ability to manage multiple and varied tasks in a fast-moving environment, good record‑keeping skills.
• Exhibits high self‑motivation and can work and plan independently as well as in a team environment.

Seniority Level

Mid‑Senior level

Employment Type

Contract

Job Function

Legal

Industries

Pharmaceutical Manufacturing