Manager – Development Regulatory Centers (drc)

5 - 8 Years
Hyderabad
Not Disclosed by Recruiter
Posted: 49 days agoOpenings: 1Job Applicants: 296Job Views: 575

Job Description

The primary responsibility of this position is to ensure:

1. All assigned projects have clearly defined regulatory strategies in order to optimize the development work and time to market
2. Regulatory filings/dossiers are prepared and/or reviewed as per established development milestones
3. Timely regulatory approval is obtained by relevant Health Authorities.

Your responsibilities:
Your responsibilities include, but are not limited to:
Elaborates global regulatory strategies for new product development.

Ensures that all strategies are scientifically sound and in accordance with relevant regulatory requirements.

Participate in project/product-related discussions and provides in-depth strategic, scientific and RA input, for CMC or procedural aspects of given project.

Ensure planning and proper organization of activities in line with the overall project plan and project milestones.

Ensure no delays in submission approval timelines or "first to file" opportunity losses due to gaps in the regulatory strategy and plans.

Responsible for preparation and review regulatory submissions (e.g. ANDS, ANDA, SNDS, NDA) and responses to Health Authority queries.

Compile/write high quality project/product specific regulatory documents to be submitted to Authorities and ensure that those documents meet regulatory requirements.

Continuously improves the quality of dossiers sent to the regulatory authorities ensuring optimal review timelines. Training and regulatory oversight.

Search, analyze, interpret and implement international regulations, guidelines and policies as they pertain to Sandoz products.

Transfer new regulatory related information by preparing internal workshops for training of both DRC and SDC personnel.

Provide regulatory training and coaching to the DRC associates, as needed.

Participate in the development and implementation of standard operating procedures.

Act as the point of contact for Global Regulatory Affairs initiatives/programs.

Provides support and coordinates with relevant SDC team members. Provide support for health authority inspections.

Minimum requirements
What you'll bring to the role:
Science degree (Pharmacy, Chemistry, Biochemistry). English, other languages are an asset.

Relevant work experience: 5 to 8 years - Minimum 5 years Regulatory Affairs experience or similar pharmaceutical regulated environment.

Original submission experience with oral dosage forms is required.

Excellent communication skills. High level of organizational skills. Positive attitude, problem solving mindset.

Extensive hands-on knowledge with CTD Module 2, 3 and 5.

Good knowledge of business process and project management in development of generics.

Solid knowledge of ICH, EMA, US FDA, ROW guidelines and regulatory procedures.

Salary: Not Disclosed by Recruiter

Industry:Pharma / Biotech / Clinical Research

Functional Area:Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology

Role Category:Drug Regulatory Affairs/Documentation

Role:Regulatory Affairs Manager

Employment Type:Full Time, Permanent

Keyskills

Desired Candidate Profile

Please refer to the Job description above

Education-

UG:B.Pharma - Pharmacy, B.Sc - Bio-Chemistry, Chemistry

Doctorate:Doctorate Not Required

Company Profile

Novartis Healthcare Pvt. Ltd.

A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes us one of the most rewarding employers in our field.
View Contact Details+

Recruiter Name:HR

Contact Company:Novartis Healthcare Pvt. Ltd.

Reference Id:283546BR

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