Regulatory Affairs Api Role with Rusan Pharma

1 week ago

Mumbai, India Rusan Pharma Full time

We have Excellent Job Opportunity for Regulatory Affairs Role (API), Kandivali.

**KRA:
- **To ensure the preparation, review and filing of annual reports, supplements, variations and periodic reports, for all approved products**
- **Timely Response of DMF deficiencies.**

**Job Responsibility:
- Planning, execution, review and submission of Drug Master File (DMF) for Regulated ,Semi Regulated & other geographical markets in CTD/eCTD format.
- Cross-functional meeting & satisfactorily addressing the deficiencies conveyed by the regulatory agencies with adequate data and within stipulated timeline.
- Compilation, review and submission of DMF amendments
- Interaction with cross functional team members of R&D, Marketing, QC, QA, Production and Purchase department on various commercial/technical issues, documentation as required for responding to queries etc.
- Provide notifications to clients for the prior-approval and annual changes. Arrange acceptance from client, schedule submissions to meet assigned goal by organization.
- Consolidate the submission plan in coordination with the business teams and ensure global regulatory filings as per the business plan.
- Review the Drug Master Files prepared by Plant Regulatory teams to ensure the submission requirements in respective countries/customer.
- Provide the inputs to the team for defining the regulatory strategy for post-approval changes with respect to specifications and methods, manufacturing process, alternate manufacturing sites, rationalized products to ensure timely support for their approvals and keep the customer updated on active and Inactive dmfs.
- Maintain and update the tracker for shared dmfs to customers, deficiency response to agencies, issued loas, shared change proposals.

**SKILLS & ABILITIES:
- M.Sc. / M. Pharmacy with 5 + years of work experience
- Hands on experience of API DMF preparation
- **Current guideline requirement awareness**:

- Advance Verbal and Written communication skills.
- Complete understanding of API global regulatory affairs
- Should have knowledge in Analytical, Quality, cGMP, Manufacturing & IP
- **Strong understanding of API development, manufacturing processes, and quality control systems.**:

- ** Detail-oriented with a high degree of accuracy and ability to work under pressure.**:

- ** Ability to multitask and prioritize tasks effectively.**

If you are not interested but know someone who might be interested, we would welcome the recommendations
- Role:
Regulatory Affairs Compliance
- Salary:
6-7 Lacs P.A.
- Industry:
Pharmaceutical & Life Sciences
- Department:
Legal & Regulatory
- Role Category:
Corporate Affairs
- Employment Type:
Full Time, Permanent
- Key Skills

Regulatory Affairs API

API global regulatory affairs

API DMF preparation

regulatory affairs

Skills highlighted with ‘‘ are preferred keyskills
- Education
- PG:
MS/M.Sc(Science) in Any Specialization

Company Profile
- Rusan Pharma
- Rusan is a research driven pharmaceutical company having its Manufacturing Units in India and Worldwide Marketing of Pharmaceutical Formulation, Active Pharmaceutical Ingredients and Intermediates. The company has its own Research & Development centre at Kandivli (west), Mumbai, state of the art, Bulk Manufacturing Plant at Ankleshwar and Formulation plant at Dehradun and SEZ, Kandla having approval of MHRA (UK), MCC (SA) and other International Health Authorities. March 2008 - 82 Crs., Expected by March 2009 €“ 150 Crs.

Contact Company:
Rusan Pharma

Address:
58-D,GOVT INDUSTRIAL ESTATE, MUMBAI, Maharashtra, India

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