Regulatory Manager / Senior Regulatory Manager

Precision for Medicine; Warszawa; Remote; PLN 190,000 - 285,000; Full time

Benefits offered by this job

Discretionary annual bonus

Private medical insurance

MultiSport Card

Life insurance

Pension

Home working allowance

Vacation

Job summary

Precision for Medicine is hiring a Regulatory Manager / Senior Regulatory Manager to provide regulatory strategy and development guidance for clinical trials, regulatory agency meetings, and orphan/paediatric planning. You will coordinate regulatory documents for submissions and lead regional/global regulatory activities while ensuring timely, compliant submissions.

The role requires CRO/pharma regulatory experience, and the ability to travel domestically and internationally.

Qualifications

• Bachelors degree or equivalent in science/healthcare.
• 5 years regulatory experience for Manager level; 7+ years for Senior Manager.
• Regulatory affairs experience in CRO or pharmaceutical industry.
• Experience leading clinical submissions and regulatory strategies.
• Willingness to travel domestically and internationally.

Responsibilities

• Provide regulatory guidance throughout the clinical development life cycle.
• Coordinate and review CTA/IND submissions and amendments.
• Develop documents for submission to Regulatory Authorities/Ethics Committees.
• Represent Global Regulatory Affairs in project teams with internal/external stakeholders.
• Lead or participate in regional/global regulatory projects and submissions.
• Oversee Regulatory Affairs Specialists to meet submission targets.
• Maintain project plans, trackers and regulatory intelligence tools.
• Support regulatory strategy for new study opportunities and timelines.
• Contribute to corporate quality initiatives and keep up with regulations.

Skills

Regulatory affairs

Clinical submissions

CTA/IND

Regulatory strategy

Orphan designations

Paediatric planning

Global regulatory

Team leadership

Regulatory meetings

Travel readiness

Education

Bachelor's degree or equivalent

Job description

Regulatory Manager / Senior Regulatory Manager

Remote, Poland

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:

• 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
• 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

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, private medical insurance, MultiSport Card, life insurance, pension, home working allowance, vacation, among other benefits.

Reasonable estimate of the current range for Poland:

190,200 PLN gross per annum to 285,400PLN gross per annum

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.

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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.

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 [e-mail] .