Ddreg Pharma Private Limited is Hiring for Regulatory Affairs Dept

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

Click here to apply and for notification 

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.

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