Recruitment for Ddreg Pharma Private Limited– 2021. Regulatory Affairs departments. M.Sc candidates are preferred. Full details are provided below.
Vacancy Details :
Name of the Company: Ddreg Pharma Private Limited
Vacancies: NA
Qualification: M.Sc, B.Sc, B.Pharma and M.Pharma
Department: Regulatory Affairs
Job Location: Hyderabad /Secunderabad, Gurgaon/Gurugram
Experience Needed: 7 to 12 years
Contact No: NA
Email I’d: [email protected] or [email protected]
Salary Package: NA
Interested candidates can send their resumes to the company email id.
Note: If interested kindly share your resume on [email protected] or [email protected]
Job Description
Roles and Responsibilities
- Providing high-quality CMC review of technical documentation for regulatory filings in emerging markets, for DDReg clients
- Drive the compilation team with high quality dossier for various regulated markets
- Providing technical consultation and provides substantive advice on strategy, regulations and industry best practices.
- Demonstrate subject matter and area expertise.
- Effectively manage CMC projects to deliver quality projects in agreed timelines.
- Collaborate with internal and external clients,
- Supporting and enabling effective and efficient communication that results in operational excellence.
- Managing CTD Modules, Medical Data Packages, SmPCs, PIs, PILs, Labelling reviews
- Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on regulatory agency websites
Desired Candidate Profile
- Excellent technical data interpretation skills
- Strong project management skills
- Excellent interpersonal skills including problem solving
- Strong negotiation skills
- Excellent oral and written communication skills with strong presentation skills
- Significant knowledge of global, regional, national and other document development guidelines
- In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc.
- Great judgment and decision-making skills
- Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
- Ability and desire to work in a team-oriented environment.
- Excellent written and verbal communication skills
- Highly proficient with Microsoft Word, PowerPoint and Excel.
- Demonstrates ability to evaluate information and data with a defined, studied process and report results in a thoughtful, organized manner
- Possesses a collaborative, results-driven style.
- Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines
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About Company
DDReg is a global pharmaceutical consulting firm that deals with regulatory services for leading pharmaceutical companies. We are a trusted partner of leading pharmaceutical companies to manage their regulatory affairs portfolio.