Regulatory Manager / Senior Regulatory Manager

Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

Precision for Medicine are recruiting a Regulatory Manager / Senior Regulatory Manager (depending on experience) to join our growing global team.

As a Regulatory Manager, you will provide 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 organised, quality regulatory submissions in compliance with applicable regulations. You will be responsible for coordinating and preparing regulatory documents for submission to Regulatory Authorities and/or Ethics Committees, as applicable.

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, 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

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

Provide 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

The ideal candidate will have the following:

Minimum Required:

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

5 years Regulatory experience required for the Manager level and 7 years Regulatory experience required for the Senior Manager Regulatory level

Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones and specialised 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.

Candidates must have regulatory affairs experience working for a CRO or within the Pharmaceutical Industry, and have experience leading Clinical 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

Competencies

Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands stemming from multifaceted research activities

Understanding of financial management

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 effectively in the English language both verbally and in written form

Conducts formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency

#LI-OS1 #LI-Remote

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice .

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.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [email protected] .

Recruitment Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at [email protected] so we can investigate and take appropriate action.