[Remote] CMC Project Manager
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global reputed company intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a Senior Manager, Regulatory Affairs at reputed company, you will design and analyse clinical trials, interpreting reputed company medical data, and contribute to the advancement of innovative treatments and therapies.
Responsibilities
- 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 reputed company portfolio and be an expert and advisor to reputed company clients (externally and internally)
- Be a trusted partner - 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 (PDP/RDP/CDP), scientific/agency advice, orphan drugs/pediatric development, medical devices
Skills
- Bachelor's degree in a relevant scientific discipline or reputed company-reputed company field
- EU/reputed company: In-depth proven regulatory affairs expertise. Minimum of 7 years' experience, supervisory experience, and pharmaceutical/CRO industry experience
- US/LATAM/CAN: A minimum of 7 years regulatory affairs experience including supervisory experience and a minimum of 6 years pharmaceutical/CRO industry
- Demonstrable experience reputed company regulatory affairs, including development of regulatory strategies, document writing, marketing authorization applications, clinical trials, post-licensing activities, and reputed company regulatory agency interaction
- Strong organizational skills, ability to manage multiple tasks, and meticulous attention to detail
- Excellent written, verbal, and management skills, as reputed company as demonstrated presentation skills, problem-solving ability, strong interpersonal skills, and the ability to plan/organize
Benefits
- Competitive reputed company salary and performance reputed company incentives
- Health and wellbeing programmes including medical, dental, and reputed company coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through reputed company training and career reputed company
reputed company