Manage - Regulatory Affairs - Pharma

Manage - Regulatory Affairs (CTA/ CTR)

Skill set Required :

Experience in CLINICAL TRIAL APPLICATION / CLINICAL TRIAL REGISTRY SUBMISSION.

Experience in EU market or CDSCO is mandatory.

Line management experience is essential.

Key Responsibilities:

- 10+ yrs relevant experience in Clinical Trial Regulatory Submissions.

- Experience in managing clinical trial studies, playing Regulatory Leads for Global trials, and exposure to the European market.

- Expertise in handling the CTIS database and submitting EU CTR is desirable.

- Line manager and Provide guidance to project team members

- Works within broad project guidelines and facilitates issue and conflict resolutions

- Prioritizes own workload and may prioritize the workload of the project team in order to achieve the project scope and objectives

- Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action

- Leverages information from previous projects or other client work to efficiently complete assigned project activities as well as facilitate business decisions

- Produces quality work that meets the expectations and the client. Reviews the work of colleagues for content and quality to ensure the expectations of the client and PC are met

- Assesses project issues and develops strategies to meet productivity, quality and project goals and objectives

- Actively manages performance including typical HR activities for direct reports (i.e. performance management reviews, salary actions, bonuses, scorecards)

- Provides a full range of technical and/or business consulting services mainly in areas where policy or precedent is clear

- Defines self-development activities in order to keep current within the industry (i.e. maintain membership in a relevant industry and/or scientific/technical association)