TRABAJO REGULATORY START UP LEAD

Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst...

regulatory affairs program lead will help robotics & digital solutions reach us and international regulatory (npd) approval goals... evaluating new regulatory requirements...

Strong understanding of regulatory requirements and guidelines for clinical trials, including ich-gcp and local regulatory requirements... in addition to your competitive...

We are looking for an experienced and hands-on antitrust & regulatory lead lawyer that will work with the hq and local legal teams, managing the day-to-day implications...

• ensure readiness for regulatory inspections by keeping documentation organized and up to date... • lead risk assessment initiatives to proactively identify and...

Accountabilities lead or manage regulatory policy priority topics as coordinated by the global regulatory policy senior directors/group head...

Understanding of how regulatory bodies approach inspections... knowledge of regulatory and development process (both pre-approval and post launch monitoring) and...

Key responsibilities: participate in global regulatory team meetings and provide advice the applicable regulatory requirements, project-specific regulatory issues...

Travel up to 10%... strong communication and regulatory writing skills... provide support for changes to existing products, including providing regulatory assessment...

Investigator brochure); regulatory documents input (e...   contributes to all regulatory reporting requirements (e...   ensures completion of medical governance...

Monitor and track legislation, regulatory development and the external environment, including proactively researching policies impacting bat regulatory agenda...

Compound lead and/or submission lead experience is preferred... able to lead process working groups... lead cross-functional document planning and review meetings...

Manages project budgets and may lead dossier authoring activities for late-stage regulatory filings with some managerial support... experience and skills: familiarity...

Act as technical lead or deputy technical lead in the company as designated... occasional supplier visits and international regulatory audits...

This role involves working closely with local regulatory affairs departments in latin america, global regulatory teams, and other cross-functional partners to ensure...

May lead cross-functional, cross-therapeutic area, or cross-j&j process improvement initiatives... maintains and disseminates knowledge of industry, company, and...

Strong knowledge of regulatory and compliance requirements (fda, gmp) is required... lead and oversee the implementation of the assets management framework and maturity...

lead in a team environment... may lead project-level/submission/indication writing teams... lead or set objectives for others on team projects and tasks, eg, lead...