Manager/ Sr. Manager (New Business Development)

DEPARTMENT: New Business Development

JOB TITLE: Manager/ Sr. Manager (New Business Development)

LOCATION: Delhi

JOB SUMMARY
The Manager 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 manager will be responsible in sourcing API products from
Indian suppliers having CEP/USDMF/ JDMF/ ASMF approvals for their products and 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

• 
  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

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 document’s 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

Strong network and connection with Indian API suppliers
Knowledge of sourcing processes
Well versed with ICH guidelines and DMF Filing, COPP, FSC and other regulatory documents
Can work independently and manage a team of RA executives
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 8 years experience in DMF filing in any regulated/ semi regulated countries