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Engaged Employer

DDReg Pharma

Compare

2.7

based on 53 Reviews

1 DDReg Pharma Senior Manager Job

AGM/Senior Manager

DDReg Pharma

2.7

based on 53 Reviews

7-12 years

Gurgaon / Gurugram

1 vacancy

AGM/Senior Manager

DDReg Pharma

posted 16d ago

Job Role Insights

Fixed timing

Key skills for the job

Pharmacy Project Management Regulatory Affairs Catering French Language Microsoft Power BI

+ 3 more

Job Description

To Manage Regulatory Affairs for Emerging (RoW) Markets/Regulated Markets (Eu / US / Canada / Japan / UK / Australia) in compliance to applicable regulations and guidelines. The responsibility include review of technical documents/dossiers, preparation and submission of Submission dossiers in CTD format, ePublish them (wherever applicable), response to queries, post approval life cycle management etc. 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 various markets key market being Saudi & GCC, for DDReg clients
Actively contribute to the development and implementation of regulatory strategies, processes and timelines for grant of MAs.
Prepares and compiles new CTD dossiers, renewals and variations 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 respective agencies for 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.
Manage multiple projects with the help of team, track the status of each project, provide update to management in a time bound manner, monitor efficiency of team members.
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 various 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
Previous experience of minimum 7 years that provides the knowledge, skills, and abilities to perform the job.

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