Global Regulatory Manager

*Why Pharm-Olam*

Pharm-Olam, LLC is a mid-size Contract Research Organization (CRO) that has a massive global reach. We are a company that strives to deliver cost-effective, quick-to-market clinical services in today's emerging marketplace. Pharm-Olam has one of the largest global footprints of any CRO today and we are committed to not only maintain our standard, but to continue to strengthen our presence even further. We offer a unique working environment with a global team culture, competitive salary and benefits package. #LI-Remote

*This is Important Work*

Typically under the direction of a Global Regulatory Sr. Manager, the Global Regulatory Manager, will be responsible for managing regulatory activities in multiple countries participating in global trials; developing and implementing strategies for timely approvals of Phase I through Phase IV applications; counselling and overseeing the local site activation associates; ensuring timely preparation and submission of regulatory documentation to European and international drug regulatory authorities as well as Independent Ethics Committees (IEC)/Institutional Review Boards (IRB); ensuring the quality, content and format of regulatory submissions; and interacting with project team members and development partners; serving as a direct Pharm-Olam point of contact for regulatory questions raised by the Sponsor, Upper Management, Client Services, BD Auditors and Inspectors.

The Global Regulatory Managerwill be responsible and accountable to keep the Site Activation Milestones (RA/IEC/IRB submission and approval) on track during the course of the study(s) managing the Local Site Activation Associate (s) therebyensuring that expectations are met while identifying and mitigating the start up risks.

This is a full-time, direct hire opportunity for an experienced Global Regulatory Professional with a strong background supportinga variety of clinical trials.

*Your Role*

* Responsible to attend the KOM if required and cover all aspects related RA/IEC/IRB submission and approval.
* Responsible for the development of Regulatory and Ethics Submission Plan (RESP) that must be signed prior 1st submission is performed.
* Coordinate the preparation of regulatory as well as ethics submissions to Regulatory Authorities as well as IEC/IRB, including original Clinical Trial Applications as well as amendment submissions: will work alongside the Global Site Activation Manager/PM ensuring submissions are performed according to internal and client expectations.
* Plan realistic timelines for submissions and approvals at study & country level, day to day management during study start-up.
* Act as a source of information for Sponsor, Upper Management, Global Site Activation Manager, Client Services, Pharmacovigilance, BD Auditors and Inspectors for Safety Requirements in countries participating in a clinical trial
* Coordinate with other departments to achieve project goals.
* Represent the company in interactions with RA/EC reviewers to pursue approvals, obtain information, and clarify issues
* In certain circumstances, may be the spokesperson for the Company in discussions with the EMA, other agencies or other companies
* Access regulatory agency websites and/or contact regulatory authority at regular intervals for updates on regulations, guidelines and procedures. Ensure these changes and updates are communicated and circulated as appropriate
* Coordinate the Local Site Activation Associates assisting the preparation, compilation and submission to Regulatory Authority (RA) and Independent Ethics Committee (IEC)/ Independent Review Board (IRB) until the corresponding approvals are in place
* Responsible for Master Subject SIS/ICF Review and Finalisation cycle with Sponsor and distribute Approved Master Subject SIS/ICF to the countries
* Responsible for Country and/or Site-Specific (*if applicable) SIS/ICF Review/ Finalisation and Approval Cycle with Sponsor

* Your Team: *

* Report directly to the Global Site Activation Manager/Project Manager if no GSAM assigned at a project level
* Oversight and support of Local Site Activation Associate (s) within study team
* Collaborate with other Departments and functional groups within Pharm-Olam, including, but not limited to: Project Management, Clinical Operations, Medical Affairs, Medical Writing, Pharmacovigilance, Data Management and Biostatistics, Quality Assurance, Business Development and Marketing Executives
* Collaborate with Pharm-Olam Medical, Regulatory, and Legal (and other) Advisors
* Liaise with Sponsor scientific, medical, and corporate staff
* Liaise with sub-contractors

*Required Education and Qualifications*

* At least a B.S. degree or other college education equivalent
* 5 to 7 years relevant technical and management regulatory experience in the pharmaceutical or CRO industries
* Indepth knowledge of the latest relevant international regulations (such as EMA, FDA, ICH/GCP…), guidelines, and regulatory trends
* Excellent interpersonal, verbal and written communication skills as well as IT proficiency
* Experience in working effectively in a team-based environment
* Manage critical projects and drive multiple projects simultaneously independently
* Special applicable skills and experience within regulatory field (e.g. medical devices, gene- therapy, Eudravigilance in conjunction with the PVG department, EudraCT registration,VHP registration, IMPD compilation, consulting and review, or similar)
* Ability to effectively attend and present at internal and external meetings (such as internal webinars or Bid Defence meetings)
* Skills in both strategic thinking and tactical implementation of regulatory strategies
* Good computer skills with good working knowledge of a range of computer programs including CTMS systems.

* Apply Now *

Please apply online at

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This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

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