Sr. Executive - Regulatory Affairs & NBD

JOB TITLE : Sr. Executive (Regulatory Affairs and NBD)

Experience : 3-4 Years

Location : Delhi

JOB SUMMARY :

The Candidate should have a techno-commercial profile, well versed with the regulatory aspects as well as the sourcing process related to sourcing qualified suppliers and API DMF filing with CDE in China. The candidate will be responsible to act as a link between China regulatory team and the Indian manufacture RA team for the review of technical and non-technical documents for the registration of API application with CDE/ NMPA, China.

KEY RESPONSIBILITY AREAS :

Sourcing (40%)

• Source API products from Indian manufacturers for registration in China market Strong network of tier A and B Class manufacturers of India
• Experience in procurement or business development encompassing DMF filing in regulated markets
• Coordinate with HO, China sourcing team and the Indian manufacturers for all the technical and commercial terms and conditions required for agreement execution
• Develop a rigorous database of Indian CEP/ USDMF manufacturers for the products as per company wish list Periodically visit Indian manufacturers for factory inspection and develop strong connections at strategic level with the relevant decision makers

Regulatory (60%)

• Coordinate with China RA team and the Indian manufacturers for all the technical and non-technical documents required for registration
• Timely follow up with the Indian manufacturer for the pending documents and the query response
• Maintain the list of queries raised by China RA team and the timeline to get the response from the Indian manufacturer for various project
• Maintain and update the trackers on the progress of the documents status of each project
• Helps in arranging the registration testing samples and related documents from the Indian manufacturer within the stipulated timeline
• Share and explain the CDE queries to the Indian manufacturer
• Intimate the Indian manufacturer for any audit conducted either by regulatory authority or any customer and coordinate the same

DESIRED SKILLS & ATTRIBUTES:

• Basic Knowledge of sourcing processes
• Well versed with ICH guidelines and DMF Filing, COPP, FSC and other regulatory documents Can work independently as well as within team
• Good verbal and written communication skills
• Outstanding project management and organizational skills

QUALIFICATIONS & EXPERIENCE:

• M. Chemistry/Pharma/ Regulatory with experience in regulatory affairs (API) for regulated markets such China, EU, US, Japan, ICH countries
• Minimum 3/4 years experience in DMF filing in any regulated/ semi regulated markets Good verbal and written communication skills (English)