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 only

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 only

Associate/Sr Associate

Job purpose

To carry out  Regulatory Review and Compilation of Technical documentation & dossiers for Biological Products 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 on biological products , for DDReg clients
  • Assist in development of  high quality dossier for Biosimilars/Biological Products for various markets
  • Demonstrate subject matter and area expertise in Biosimilars/Biological Products.
  • 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 Biotech/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

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

Business Development

Job Purpose 

To drive Business Development for DDReg Group companies

Duties and responsibilities

  • Lead generation, Business Planning and Development, Client Relationship Management, Deal Negotiation, Developing New Markets, Alliance Management
  • Identifying, qualifying, and securing business opportunities for Regulatory, Drug Safety/Pharmacovigilance and Medical Writing Services
  • Building business relationships with current and potential clients
  • Collaborating with leadership to secure, retain, and grow accounts
  • Developing customized targeted sales strategies
  • Creating informative presentations; Presenting and delivering information to potential clients at client meetings, industry exhibits, trade shows, and conferences
  • Coordinating business generation activities
  •  Responding to client requests for proposals (RFPs)
  • Answering potential client questions and follow-up call questions
  • Creating and maintaining a list/database of prospect clients
  •  Maintaining short- and long-term business development plans
  • Maintaining database (Salesforce, CRM, Excel, etc.) of prospective client information
  • Cold calling; making multiple outbound calls to potential clients from Global Pharmaceutical Industry
  • Understanding client needs and offering solutions and support
  • Researching potential leads from business directories, web searches, or digital resources
  • Qualifying leads from digital campaigns, conferences, references, tradeshows, etc.
  •  Meeting all quotas for cold, active, inactive calls, appointments, and interviews
  • Maintaining a pipeline of all sales administration using CRM software
  •  Collaborating with management on sales goals, planning, and forecasting

  

Education & Experience

·         Bachelor's or Master’s degree in Pharma or related

·         3+ years previous experience that provides the knowledge, skills, and abilities to perform the job  or equivalent combination of education, training, & experience.

·         Experience working in the pharmaceutical/CRO industry preferred

 

Knowledge, Skills and Abilities

 Experience with lead generation and prospect management
·         Comfortable making cold calls and talking to new people all day
·         Excellent verbal and written communication skills; the ability to call, connect and interact with potential customers
·         Persuasive and goal-oriented
·         Possesses an energetic, outgoing, and friendly demeanor
·         Eager to expand company with new sales, clients, and territories
·         Self-motivated and self-directed
·         Able to multitask, prioritize, and manage time efficiently
·         In-depth understanding of company services and its position in the industry
·         High school degree or equivalent; Bachelor degree preferred
·         Four years of cold calling experience; Previous experience in outbound call center, inside sales experience, or related sales experience
·         Excellent written and verbal communication skills; able to demonstrate patience and enthusiasm while communicating with potential clients
·         Able to professionally and confidently communicate with C-Level Executives
·         Able to work accurately under stress and pressure to meet competing deadlines
·         Excellent analytical and time-management skills
·         Demonstrated and proven sales results
·         Creative problem solver who thrives when presented with a challenge
·         Tenacity to handle rejection and continue on with a positive attitude when reaching next potential client
·         Knowledge of sales process from initiation to close
·         Ability to work independently or as an active member of a team
·         Strong computer skills, including Microsoft Office Suite (Word, PowerPoint, Outlook, and Excel) and CRM/ Salesforce experience preferred

Other requirements

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

 Location

Gurugram (INDIA)

 

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