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Regulatory Lead

AIXIAL is an International Contract Research Organization (CRO), a member of the ALTEN Group, providing complex services in clinical trials (phase I-IV) and non-interventional studies. Our offices are located in France, Belgium, Germany, Czech Republic and India.


Due to fast growth of our company we are currently recruiting a colleague for the position of an Regulatory Lead, the position would be based in Pune.


Principal Responsibilities:

Regulatory Project Management

• Understands contractual obligations and the scope of work. Proactively recognizes any changes in scope and ensures timely completion of change orders.

•Secures global regulatory resource as required per project. Communicates effectively with, sets expectations, directs, and oversees the work of these regulatory resources. Manages utilization and productivity and proactively resolves any issues.

•Manages projects in adherence with Cmed SOPs, ICH-GCP, ISO, and other applicable guidelines and regulations. Communicates progress, challenges, risks, issues, actions and decisions in the manner and timings agreed in the applicable Operational Plan(s).

•Attends client and team meetings, including kick-off, as directed; develops and presents start-up/regulatory slide content.


Regulatory Affairs

• Develops and executes regulatory strategy per project. Contributes to regulatory operational plan and timeline development; proactively drives the achievement or betterment of the standards and timelines therein.

•Provides regulatory review and/or input into essential documents, including but not limited to: protocol, investigator’s brochure, and participant informed consent documents. Overall accountable for core application packet development and review/approval of country/site level submission packets.

•Coordinates regulatory/start up activities as required, including RA/EC query resolution, management of document translations, and quality review of site document packets. Maintains accurate metrics of planned and completed regulatory deliverables.

•Responsible for leading interactions with the concerned Regulatory Agencies, and where appropriate, concerned ethics committees, globally.

Non-billable Activities

Participates in business development including consulting, sales and marketing support, and proposal and budget development. Supports bid defense meetings as required.

•Engages with and leads initiatives to drive process improvement. Prepares and delivers departmental trainings, as required.

Additional

The above job description in no way states or implies these duties are the only duties performed by this employee. The incumbent is expected to perform other related duties necessary for the effective operation of the department and company.

The Company reserves the right to change or alter any of the above duties and responsibilities according to the operational needs of the department and Company.

Essential Work Experience, Qualifications and Knowledge:

•Background in medicine, nursing, pharmacy, life science or other relevant discipline with appropriate experience

•Meets all proficiency requirements for Regulatory Lead and exceeds those for Regulatory Specialist/Associate levels

•Fluent in written and spoken English. Additional language skills desirable

• Computer literate


Desirable Work Experience, Qualifications and Knowledge:

• Thorough understanding of regulatory agency and ethics committee requirements in at least one region/market

• Understanding of ICH, ISO, GCP, GMP and other relevant regulations and guidelines for the conduct of clinical trials and maintenance of marketing authorizations related to pharmaceuticals, biologics, advanced therapies, medical devices, and combination products

Posted
07/09/2022
Location
pune, MH, IN