Recruitment for Maxima Executive Search Pvt Ltd – 2021. Hiring for Regulatory Affairs departments. Masters in science / Pharmacy Graduate/Ph.D candidates are preferred. Full details are provided below.
Vacancy Details :
Name of the Company: Maxima Executive Search Pvt Ltd
Qualification Needed: Masters in science / Pharmacy Graduate/Ph.D
Department: Regulatory Affairs
Post Name: Regulatory Affairs Manager
Job Location: Bangalore
Experience Needed: 6+ years
Contact No: NA
Salary Package: NA
Interested candidates can send their resumes to the company email id.
Roles and Responsibilities
- Management of Product Approvals & Licenses of Pharmaceutical products for the Countries i.e., Bangladesh, Brunei, Cambodia, Sri Lanka, Maldives, Myanmar and Under assessment: Lao & Bhutan
- To develop solid Regulatory strategy and ensure flawless execution of all local regulatory affairs and Global regulatory compliance requirements
- Lead interactions with Regulatory Authorities related to regulation, guidelines, Recall, Complaints and NSQ.
- Liaison with State Health Authorities and central health authority for grant of various Licenses as per D&C act, GMP certification and tender certificates.
- Communicate the impact of changes to key stakeholders
- Development of new product strategy and co-ordination with cross functional teams.
- Ensures local language medical and scientific literature is periodically reviewed to identify possible case reports, and forwards all the above in a timely manner to the appropriate Data Entry Site
- Have current knowledge of products manufactured and marketed across different markets in AAFM
Desired Candidate Profile
- Masters in science / Pharmacy Graduate/Ph.D with 6+ years experience in handling Regulatory Affairs and Patient safety
- Relevant experience with regulations related to New product registration, Manufacturing site registration, Import of new drugs and Clinical trial regulations
Maxima Executive Search Pvt Ltd serve a wide range of clients from some of world’s largest multinational corporations, governments and global banks to hi-tech startups, consulting companies and venture capital firms. Our clients are spread globally and we have carried out search assignments in all major geographies