Global Regulatory Affairs Lead — Clinical Trials

Precision Medicine Group; United States; Hybrid; USD 106,000 - 151,000; Full time

Benefits offered by this job

Discretionary bonus

Health insurance

Retirement benefits

Life insurance

Disability benefits

Parental leave

Paid time off

Job summary

Precision Medicine Group is seeking a Regulatory Manager to provide regulatory development guidance for clinical trials, ensuring timely, quality submissions in compliance with regulations.

You will coordinate documents for Regulatory Authorities and Ethics Committees, support corporate Regulatory function, and lead regional or global regulatory activities while traveling domestically and internationally as needed. Strong communication and leadership are essential.

Qualifications

• 5+ years regulatory affairs experience
• Knowledge of EU/US regulatory submissions (IND/CTA, amendments)
• Ability to travel domestically and internationally
• Understanding of drug development process and regulatory milestones
• Knowledge of ICH GCP guidance and clinical trials methodology

Responsibilities

• Provides regulatory guidance throughout the clinical development life cycle
• Compile, coordinate and review applications to Regulatory Authorities including CTA/IND, annual reports and amendments
• Develops and/or reviews documents for submission to Regulatory Authorities and Ethics Committees
• Represents Global Regulatory Affairs at project team meetings
• Leads projects for the region or globally as needed
• Oversees Regulatory Affairs Specialists to meet submission targets
• Maintains project plans, trackers and regulatory intelligence tools
• Contributes to regulatory strategy and timelines for new study opportunities
• Maintains company standards for submitted information
• Participates in corporate quality initiatives across units
• Keeps up-to-date with laws and guidelines governing drug development
• Provides ICH GCP guidance to internal and external clients
• Represents Global Regulatory Affairs at business development meetings

Skills

regulatory affairs

project management

stakeholder communication

travel readiness

Education

Bachelor's degree

Job description

The Regulatory Manager (RM) provides regulatory development advice and guidance for optimal conduct of clinical trials, 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 a current knowledge of regulations and guidance documents, providing analysis to project teams, as well as supporting and enhancing Precision for Medicines corporate Regulatory function.

Essential functions of the job include but are not limited to:

• Provides regulatory guidance throughout the clinical development life cycle
• Compile, coordinate and review applications to Regulatory Authorities including, but not limited to, CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, pediatric 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
• Serve 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
• Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs
• Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated.
• Assist in development of Regulatory Affairs Specialists and other operational area staff, as required
• P rovide input, as required, into regulatory strategy and timeline development for new study opportunities Assists in establishing company standards to ensure the highest quality of submitted information
• Participates in maintaining and executing on the corporate quality initiatives across business units within clinical solutions.
• Keeps abreast and continually expand knowledge of laws, regulations and guidelines governing drug development and approval
• Provides ICH GCP guidance, advice and training to internal and external clients
• Serve as representative of Global Regulatory Affairs at business development meetings

Qualifications:

• Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline

Preferred:

• Possesses basic understanding of financial management

Other Required:

• 5 + years or more relevant regulatory affairs experience
• Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones
• Specialized knowledge of regulatory activities for at least one major region (EU, US) including but not limited to submissions to Regulatory Authorities, including INDs/CTAs and amendments, Scientific Advice Procedures, and post-approval submissions
• Ability to understand clinical and pre-clinical study results, to help in its interpretation for regulatory positions and strategy
• Knowledgeable of clinical trials methodology, including a working knowledge of protocols and indications being studied
• Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development
• Availability for domestic and international travel including overnight stays
• 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 is able to work and plan independently as well as in a team environment
• 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 prioritize workload to meet deadlines with little support from management
• Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective
• Collects data of consistently high standard
• Communicates both verbally and in written form in an acceptable manner
• Conducts formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency

Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.

Reasonable estimate of the current range

$106,000 - $151,000 USD

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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

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