Deputy General Manager - Regulatory Affairs

Job Description:

-Position Title: Deputy General Manager - Regulatory Affairs

-QUALIFICATIONS, EXPERIENCE, & SKILLS:

• Minimum Qualifications: B. Pharma/ M.Pharma        
• Minimum Experience: 15-20 years

-Reports to: Vice President

-Department: Regulatory Affairs

Division: - Healthcare

-JOB PURPOSE:

• To submit registrations in new markets/geographies for the organization as per management plan
• To obtain necessary FDA licenses and DCGI / CBN export NOC’s for as per the business requirement.

-KEY DUTIES AND RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO THE FOLLOWING ACTIVITIES:

1)To review and send the product registration dossiers for  product registration of

-Existing products in new geographies as per agreed planner in African countries like Kenya, Tanzania, Nigeria, Ghana, Zambia, French West Africa etc.

-New products in existing and new geographies

2)To develop dossier in CTD format that is acceptable to the Ministry of Health of African countries to register products of interest.

3)To update the team on the regulatory changes as per country specific guidelines.

4)To formulate and implement regulatory/statutory requirements in the artworks for the products in various African markets

5)To obtain various certificates/license/NOCs/Narcotic permits from local as well as central FDA required for dossier compilation and business requirements.

6)To obtain WHO GMP certification for the plant and LLU units (our products). 

7)To be updated with the changing regulatory guidelines of importing countries to make the necessary statutory changes to the documents and plants for registration.

8)To keep tab of validity of various manufacturing licenses, loan licenses and warehouse licenses are renewed in time to avoid legal hassle and smooth flow of work

-COMMUNICATIONS & WORKING RELATIONSHIPS:

Internal: NBD,PPIC,Finance & Accounts, CQA,Procurement,Medical, F&D, ADL, SCM Dubai & Jejuri Plant

External: Regulatory counterparts in Africa, OU’s, Third party Manufacturer, LL, FDA, CBN, DCGI & CDSCO Offices, other service providers.

-Job Specific Skills:  Know how of CTD Dossier preparation for Africa market as per WHO Guidelines, Interpersonal skills, Good communication, Computer Knowledge.

-COMPETENCIES:

• Good relationships with various FDA offices of concern
• Good product knowledge