Career

Build Your Career With Us

We work closely with our employees to build an innovative, creative and rewarding work environment DDReg is a dynamic and growing organization. For last 9 years we have been working smart and hard - getting our work and service quality heard right across the pharma world. Working here means you can get stuck in right away, have your ideas heard, work in collaboration with a young, dynamic and motivated team, and make a difference.

We are having group of young extremely enthusiastic employees who are focused and dedicated in providing quality services. We are looking for candidates who are passionate and have a vision to establish themselves in the regulatory and drug safety management. We keep seeking individuals with a Post Graduate Degree in Pharmaceuticals and Life Sciences and experience in handling Regulatory Affairs of emerging & developed markets and in Drug Safety.

We also welcome fresh post graduates in Pharmaceuticals and Life Sciences, as we provide opportunity to learn and start your careers with a growing regulatory consulting company. If you are interested send your CV to info@ddreg.in and we shall get back to you with exciting opportunities, as they emerge!!

Sr Associate/Team Lead -Adv Mkts (SRA/TL)

Job purpose

To Manage Regulatory Review and Compilation for Various Markets in compliance to applicable regulations and guidelines.

Duties and responsibilities

  • Providing high-quality CMC review of technical documentation for regulatory filings in EU and US 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 like US FDA, EMA, PMDA, TGA, UKMHRA etc.

Education & Experience

  • Bachelor's or Master’s degree in Pharma
  • 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,/li>
  • 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

Other requirements

As may be required from time to time – the incumbent may be required to working slots catering to different time zones

Location

  • Gurgaon
  • Mumbai

Regulatory Associate – LCM (RA-LCM)

Job purpose

To carry out Regulatory Review and Compilation of Technical documentation & dossiers as part of Life Cycle Management of products in compliance to applicable regulations and guidelines.

Duties and responsibilities

  • Providing high-quality CMC review of technical documentation i.e CTD Modules, Medical Data Packages, SmPCs, PIs, PILs, Labelling documents, for regulatory filings in emerging markets, for DDReg clients
  • Review and/or compilation of (as per country specific regulatory requirements) a. re-registration) dossier, b. variations
  • Carrying out all other regulatory activities pertaining to Life Cycle Management (LCM) of products in International markets.
  • Experience of EU, South Africa and Australia/New Zealand preferred
  • Adequacy Review and Gap Analysis of documents for LCM purpose
  • Preparation of renewal & variation packages
  • Responses to deficiency letters.
  • 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.
  • Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on regulatory agency websites

Education Experience

  • Master’s degree in Pharma discipline
  • 2-3 years of experience in handling Regulatory Affairs function – specifically in the area of Life Cycle Management

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

Other requirements

As may be required from time to time – the incumbent may be required to working slots catering to different time zones

Location

  • Mumbai
  • Gurgaon

Sr Associate/Team Lead- RoW Mkts (SRA/TL)

Job purpose

To carry out  Regulatory Review and Compilation of Technical documentation & dossiers for Various Markets in compliance to applicable regulations and guidelines.

Duties and responsibilities

  • Providing high-quality CMC review of technical documentation i.e CTD Modules, Medical Data Packages, SmPCs, PIs, PILs, Labelling documents,  for regulatory filings in emerging markets, for DDReg clients
  • Assist in development of  high quality dossier for various markets
  • 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.
  • Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on regulatory agency websites

Education & Experience

  • Master’s degree in Pharma discipline

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

Location

  • Gurgaon
  • Mumbai

Sr Associate – Medical Writing (SRA-Med)

Job purpose

To plan and Manage Medical Writing for different Verticals in compliance to applicable regulatory and Regulatory Guidelines

Duties and responsibilities

  • Providing high-quality medical and scientific writing from planning and coordination of literature search through delivery of final drafts to internal and external clients.
  • Providing technical consultation and provides substantive advice on strategy, regulations and industry best practices.
  • Demonstrate subject matter and therapeutic area expertise.
  • Effectively manage medical writing projects to deliver quality products in agreed timelines.
  • Collaborate with internal and external clients,
  • Writing CTD Modules, Medical Data Packages, SmPCs, PIs, PILs, Safety Reports, Aggregate Reports and other reports
  • Perform science review of aggregate reports produced by PV Associates
  • Ensure that document output and processes comply with client specifications, templates and styles guidelines
  • Attend project initiation meeting, collate project brief.
  • Maintain awareness of current regulatory guidance, medical information techniques and technology relating to clinical / regulatory documentation
  • Supporting Medical safety team in ongoing review and management of safety information
  • Maintain & update Aggregate Report Tracker and carry out cases reconciliation on periodic basis
  • Supporting and enabling effective and efficient communication that results in operational excellence.
  • Carry out detailed searches in regulatory agency websites like US FDA, EMA, PMDA, TGA, UKMHRA etc for safety alerts
  • Mentor Associates on job skills, oversees or develops training plans or materials for safety associates, conducts training sessions, or otherwise trains new hires and enhances the skills of existing personnel.

Education & Experience

  • Master's degree in a Pharmacology/Pharmacy/Medicine
  • Advanced degree preferred
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years’) or equivalent combination of education, training, & experience.
  • Experience working in the pharmaceutical/CRO industry preferred
  • Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous

Knowledge, Skills and Abilities

  • Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading 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.
  • Ability to work under pressure and provide quality outputs within tight timelines

Location

  • Gurgaon
  • Mumbai

Associate – Regulatory Affairs (RA)

Job purpose

To carry out  Regulatory Review and Compilation of Technical documentation & dossiers for Various Markets in compliance to applicable regulations and guidelines.

Duties and responsibilities

  • Providing high-quality CMC review of technical documentation i.e CTD Modules, Medical Data Packages, SmPCs, PIs, PILs, Labelling documents,  for regulatory filings in emerging markets, for DDReg clients
  • Assist in development of  high quality dossier for various markets
  • Adequacy Review and Gap Analysis of Technical Documentation for Non-CTD/CTD dossier compilation.
  • Closure of comments with the cross functional team & review of additional data generated in response to review comments per country.
  • Compilation of Dossier.
  • Review of registration dossier (m1-m5) as per country specific regulatory requirements
  • Deficiencies response management from various authorities by coordinating stakeholders
  • for getting documents and compilation and review of response and compile response toqueries from the MOH.
  • Updation of the dossier as per the queries responded (inclusive of all countries)
  • Demonstrate subject matter and area expertise.
  • Collaborate with internal and external clients,
  • Supporting and enabling effective and efficient communication that results in operational excellence.
  • Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on regulatory agency websites

Education & Experience

  • Master’s degree in Pharma discipline

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

Other requirements

As may be required from time to time – the incumbent may be required to working slots catering to different time zones

location

  • Gurgaon
  • Mumbai

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