DDReg Pharma Pvt. Ltd Jobs for Asst.manager( Regulatory Affairs)

Asst. manager(Regulatory Affairs)- Gurgaon – 5+ years exp DDReg Pharma Pvt. Ltd

Job purpose

To Manage Regulatory Affairs for EU/Canada/Australia Markets in compliance to applicable regulations and guidelines. This position will assist with the review of CMS documentations, preparation and submission of eCTDs, Variations, site transfers and post approval gap analysis. This position will also provide support of the regulatory function through document management, electronic submission compilation and management, and other group management activities as required. Position will be required to work with Regulatory Affairs, Quality Assurance, Quality Control, Manufacturing, Research and Development groups of the client organization of DDReg.

Duties and responsibilities

Providing high-quality CMC review of technical documentation for regulatory filings to European Medicinal Agency (EMA), UK MHRA, National Agencies of EU Member states, Canada, Australia for DDReg clients

Running De-centralized Procedures, MRP and procedures for national filings in EU Members states, Health Canada, TGA Australia

Actively contribute to the development and implementation of regulatory strategies, processes and timelines for EU/UK/Australia/ Canada and global approval.

Prepares and compiles new CTDs, Variations (Major/Minor/Site Transfers) filings ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met.

Critically reviews documentation intended for submission to the above mentioned agencies, internal consistency, for consistency to relevant guidelines and to promote regulatory excellence.

Demonstrate subject matter and area expertise.

Collaborate with internal and external clients,

Supporting and enabling effective and efficient communication that results in operational excellence.

Providing technical consultation and provides substantive advice on strategy, regulations and industry best practices.

Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on agencies website.

Monitor competitive regulatory practices, and actively review internal and external factors to mitigate potential problems.

Ensure that draft labeling complies with all applicable regulations and guidelines

Education & Experience

Bachelor’s or Master’s degree in Pharma with 5 years of Experience
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’) or equivalent combination of education, training, & experience.
Experience working in the pharmaceutical/CRO industry preferred

Knowledge, Skills and Abilities

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