Ad-Promo Regulatory Manager
ICON plc
full-time
Posted on:
Location Type: Remote
Location: Mexico
Visit company websiteExplore more
Tech Stack
About the role
- Participate in provision of regulatory expertise in strategic drug development across multiple areas.
- Take part in preparation of strategic development and submission plans.
- Be involved in the regulatory affairs activities across the ICON portfolio and be an expert and advisor to ICON clients.
- Represent the Regulatory Affairs Department in business development activities and generate new business opportunities.
- Contribute to at least two of the following areas: interactions with regulatory agencies, early phase consulting, development planning, scientific/agency advice, orphan drugs/pediatric development, medical devices, regulatory intelligence, due diligence, strategic CT support/GCP compliance, biological/biotech/biosimilars, small company support (incl. SOPs development etc.).
Requirements
- Minimum of 7 years’ experience in regulatory affairs
- Supervisory experience
- Pharmaceutical/CRO industry experience
- Demonstrable experience within regulatory affairs, including development of regulatory strategies, document writing, marketing authorization applications, clinical trials, post-licensing activities, and direct regulatory agency interaction.
- Strong organizational skills
- Ability to manage multiple tasks
- Meticulous attention to detail.
- Excellent written, verbal, and management skills
- Demonstrated presentation skills
- Problem-solving ability
- Strong interpersonal skills
- Ability to plan/organize.
Benefits
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory expertiseregulatory strategiesdocument writingmarketing authorization applicationsclinical trialspost-licensing activitiesregulatory agency interactionGCP complianceSOPs developmentregulatory intelligence
Soft Skills
organizational skillsability to manage multiple tasksattention to detailwritten communication skillsverbal communication skillsmanagement skillspresentation skillsproblem-solving abilityinterpersonal skillsplanning and organizing