
Operations Lead
2 weeks ago
Operational Manager
Job DescriptionThe Operational Manager plays a key role in ensuring the smooth operation of our business. This includes managing new dossier preparation and submission, gap analysis for completion, and compilation of dossiers in eCTD format for submission to various regulatory authorities.
Additionally, the Operational Manager is responsible for coordinating submissions of dossiers in various countries, evaluating queries, and reviewing query responses received from manufacturers.
Key Responsibilities- Manage new dossier preparation and submission
- Gap analysis for completion
- Compilation of dossiers in eCTD format for submission to various regulatory authorities
- Coordinate submissions of dossiers in various countries
- Evaluate queries
- Review query responses received from manufacturers
- Post-approval lifecycle management of products (variations)
- Receipt of variation/renewal packages from FPP manufacturers or initiation of variations from Innovata's end
To be successful in this role, you will need to have excellent communication skills, both written and verbal. You should also be highly organized, with the ability to prioritize tasks effectively and manage multiple projects simultaneously.
Additionally, you will need to have a strong attention to detail, with the ability to identify and resolve issues quickly. Proficiency in MS Office, particularly Excel, is also essential.
BenefitsWe offer a competitive salary package, as well as opportunities for career development and growth. Our team is friendly and supportive, and we strive to create a positive and inclusive work environment.
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