Regulatory Affairs Executive

2 months ago


Remote, India Zetta Women Full time

**Job Title**:Pharmaceutical Regulatory Affairs Executive **(Intern)**

**Location**: Pune, India

**Duration**: 9 months (Advanced Certification) + 3 months (On the Job Internship)

**Job Summary**:
**Key Responsibilities**:
1. Attend classes on weekends (Saturdays and Sundays)

2. Complete coursework, assignments, and projects

3. Participate in discussions, case studies, and group activities

**Internship **(Monday to Friday):
1. Assist regulatory affairs teams in associated companies

2. Gain hands-on experience in regulatory submissions, documentation, and compliance

3. Develop understanding of Indian regulatory framework (CDSCO, DCGI, others)

4. Collaborate with cross-functional teams (R&D, Quality, Manufacturing)

5. Prepare and review regulatory documents (e.g., ANDA, NDA, DMF, etc)

**Requirements**:
1. Bachelor's/Master's degree in Pharmacy, Life Sciences, or related fields

2. Freshers **or **up to 1 year of experience in regulatory affairs

3. Strong analytical, communication, and interpersonal skills

4. Ability to work in a fast-paced environment

5. Willingness to learn and adapt to new regulations and guidelines

**Desirable Qualifications**:
1. Basic knowledge of regulatory affairs and pharmaceutical industry

2. Familiarity with Indian regulatory framework (CDSCO, DCGI)

**Benefits**:
1. Hands-on experience in regulatory affairs

2. Networking opportunities with industry professionals

3. Placement assistance after completing the internship (after the mandatory 3 months OJT)

4. Internationally recognized certificate from London School of Pharmaceutical Education, UK

**How to Apply**:
1. Resume

2. Cover letter explaining interest in regulatory affairs

3. Contact information for two professional references

**Deadline**:30th Nov. 2024

**Job Type**: Fresher

Pay: ₹5,000.00 - ₹10,000.00 per month

Schedule:

- Weekend availability
- Weekend only

Work Location: Remote

Application Deadline: 30/11/2024
Expected Start Date: 15/12/2024


  • Regulatory Affairs

    7 months ago


    Remote, India Comtec IT Services Full time

    Regulatory Affairs Associate Manager Location: Remote Duration: 7 months RESPONSIBILITES: - Validate product composition, ingredient lists, develop nutritionals and advise on/approve regulated claims for compliance under US laws and regulations - Participate in validation of marketing campaigns and review of associated materials - Approve packaging...


  • Remote, India Parexel Full time

    As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter - and keeping them there -your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical...


  • Remote, India Parexel Full time

    **Regulatory Affairs Associate** - Around 2 to 4 years of relevant experience in handling of pre and post approval life cycle management of drug products (small molecules as well as biologics) in various markets. - Contribute to preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory...


  • Remote, India Parexel Full time

    As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter - and keeping them there -your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical...


  • Remote, India Parexel Full time

    As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter - and keeping them there -your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical...


  • Remote, India Endeavor Consulting Group Full time

    Leading Global Cosmetics Consumer Products, Personal Care / Pharmaceutical corporation has an immediate need for an experienced Regulatory Affairs Associate. This is an excellent opportunity to join one of the world’s most respected and trusted companies. **Responsibilities**: - Review and respond to project team cross functional partners to provide...


  • Remote, India ProductLife Group Full time

    **Responsibilities**: - Contribute to regulatory activities performed on the RA Platform/the Hub. Regulatory activities include pre licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions. - To contribute to the production of client administrative documents to be included in regulatory submissions -...


  • Remote, India Parexel Full time

    As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter - and keeping them there -your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical...


  • Remote, India Medidee Full time

    Hyderabad **EMAIL** I **Career opportunity** **Consultant - Medical Device Regulatory and Clinical Affairs** **Project Associate - Remote, India** Diagnostics compliance with international regulatory requirements. We serve clients with hands-on support for compliance with applicable regulatory requirements of our clients’ target markets. Our...


  • Remote, India Parexel Full time

    As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter - and keeping them there -your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical...


  • Remote, India Parexel Full time

    As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter - and keeping them there -your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical...


  • Remote, India Britts Imperial University College Full time

    **Job Description - Admission Affairs Executive** **About the company**: Britts Imperial Education Group is an Academic Centre and Education Partner to globally recognized British and European Universities that offer Undergraduate, Postgraduate and Doctoral programs to aspiring learners from across the globe. **Essential Roles and Responsibilities**: As an...


  • Remote, India Parexel Full time

    **Job Description**: - 4-6 yrs of experience in handling of pre and post approval life cycle management of Biologic products in various markets Regulated (EU/US/Canada) and Emerging Markets. - Experience of support the compiling, submission, and approval of country-specific submission files (MAA, LCM, and post-approval changes). Contribute to preparation...


  • Remote, India ProductLife Group Full time

    **Required education**: Degree in relevant life science discipline **Required Experience**: 2-4 years relevant experience **Required Technical Skills**: - Lifecycle maintenance experience - Providing support during external and unannounced audits. - Responding to internal requests for technical and/or regulatory information. - Preparation and submission...

  • Reg Affairs Spec

    3 months ago


    Remote, India Thermo Fisher Scientific Full time

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed...


  • Remote, India Parexel Full time

    As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter - and keeping them there -your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical...


  • Remote, India Parexel Full time

    As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter - and keeping them there -your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical...


  • Remote, India Thermo Fisher Scientific Full time

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Summarized Purpose**: Serves as the lead over several countries/projects in providing innovative solutions including regulatory expertise and client interface to provide strategic regulatory intelligence, and guidance supporting product development from preclinical through...

  • Drug Safety Associate

    6 months ago


    Remote, India Satyam Group Full time

    Responsibilities: - Receive and process adverse event reports from various sources, including healthcare professionals, consumers, and clinical trials. - Conduct initial assessment of reported adverse events to determine seriousness, expectedness, and causality. - Enter adverse event data into safety databases accurately and in a timely manner, ensuring...

  • Quality Executive

    7 months ago


    Remote, India The Organic World Full time

    Hiring for Quality Executive - Regulatory Master in Science(Microbiology,Biochemistry,Chemistry) 2-3 Years Min Foods industry. Updated FFSAI/Requlatory guidelines on time so that we can implement as per timeline at Plant level/Product Plant and vendor audit will be done so that any improvements is requirment we can do as when required FSSAI Any Approval is...