Lead Associate - Reg. Affairs
Vue: 111
Jour de mise à jour: 06-05-2024
Localisation: Mumbai Maharashtra
Catégorie: Science La main doeuvre
Industrie: Information Technology
le contenu du travail
Are you the one we are looking for?
We are inviting applications for the role of Lead Associate or Lead Consultant, Regulatory affairs.
In this role, you are responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance, and defined regulatory strategies along with the preparation and review of the information required for the development of regulatory CMC dossiers for commercial products.
Responsibilities:
- Work on authoring CMC documentation for worldwide marketing of pharmaceutical products for initial registration and life-cycle management under the direction of team scientists.
- Experience in reviewing scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data.
- Able to prioritize & execute the project according to the project plan/timelines/schedules.
- Work with cross-functional teams to track and follow up outstanding documentation, coordinate on project status & reporting to stakeholders using different communication channels.
- Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills.
- Demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance).
- Ability to generate innovative solutions to problems and effectively collaborate with and communicate with key stakeholders.
- Active participation in departmental improvement activities such as system modifications, maintenance of standard operating procedures, internal guidelines, etc.
- Demonstrated flexibility in responding to changing priorities, multi-tasking, and dealing with unexpected events.
Minimum Qualifications
- Bachelor’s or master’s degree required in science, engineering, or related field (advanced degree preferred)
- Effective leadership, communication, and interpersonal skills
- Advanced knowledge of MS Office
- Superior attentiveness to detail
JobLead Associate
Primary LocationIndia-Mumbai
Education LevelBachelor’s / Graduation / Equivalent
Job PostingAug 4, 2021, 1:41:00 PM
Unposting DateOngoing
Master Skills ListOperations
Job CategoryFull Time
Date limite: 20-06-2024
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