Biological E. Limited (under its Vaccine Business) are seeking applications for the post of Regulatory Affairs – CTD Authoring Specialist – Bio.
This is for an experienced person (5–10 years’ experience) in Regulatory Affairs, specifically in the area of biologics and vaccine regulatory documentation.
Candidates should have hands on experience in CTD dossier authoring, CTD/eCTD formats and the preparation of regulatory submission documents.
Interested applicants should send in their updated CV to the recruitment team at Vaishnavi.Neemkar@biologicale.com
This is for an experienced person (5–10 years’ experience) in Regulatory Affairs, specifically in the area of biologics and vaccine regulatory documentation.
Candidates should have hands on experience in CTD dossier authoring, CTD/eCTD formats and the preparation of regulatory submission documents.
Interested applicants should send in their updated CV to the recruitment team at Vaishnavi.Neemkar@biologicale.com
Company Overview
It’s a pharma and biotech company, specialising in vaccine development and manufacture.
Via its Vaccine Business the company is seeking experienced Regulatory Affairs people to support on regulatory documentation, dossier preparation and global submissions.
This is for people
working in Regulatory Affairs, biologics, vaccines and regulatory dossier writing.
Biological E. Limited Job Details
- Company: Biological E. Limited
- Business Unit: Vaccine Business
- Department: Regulatory Affairs
- Job Title: CTD Authoring Specialist – Bio
- Experience: 5–10 Years
- Specialisation: Biologics and Vaccine Regulatory Documentation
- Qualification: Not stated in the recruitment advert.
- Job Location: Not mentioned.
- Employment Type: Not specified.
Job Role & Responsibilities
The selec
ted candidate will support regulatory dossier preparation and documentation for biologics and vaccine-related products.
Key Responsibilities
- Prepare, author and review regulatory documents for biologics submissions.
- Develop and maintain CTD dossiers in line with the relevant regulatory requirements.
- Work
- on CTD and eCTD documentation formats for regulatory submissions.
- Review the technical documentation to ensure it’s accurate, consistent and complete.
- Support the preparation of regulatory submission packages for biologics and vaccines.
- Ensure r
- egulatory documents meet applicable submission standards and documentation requirements.
- Apply your knowledge of the global regulatory guidelines when preparing and reviewing regulatory dossiers.
Eligibility & Qualifications
Biological E. Limited is seeking experienced Regulatory Affairs people with relevant biologics and regulatory dossier authoring experience.
Educational Qualifications
The recruitme
nt announcement does not specify a mandatory educational qualification.
Candidates with relevant academic backgrounds in the following areas may find this opportunity relevant:
- B.Pharm
- M.Pharm
- Pharm.D
- B.Sc. / M.Sc. in Biotechnology
- B.Sc. / M.Sc. in Life Sciences
- Relevant qualifications in Pharmaceutical Sciences or related disciplines
Note: The above are suggested relevant educational qualifications, not the officially confirmed eligibility criteria.
Experience Requirements
- Required experience: 5–10 years.
- Relevant experience in Regulatory Aff
- airs.
- Hands on experience in authoring CTD dossiers for biologics.
- Experience in regulatory documentation for biologics and/or vaccines.
- Practical exposure to CTD/eCTD formats and regulatory submissions.
Required Skills & Technical Knowledge
Candidates should possess the following skills:
- CTD dossier authoring and preparation.
- CTD/eCTD regulatory documentation.
- Biologics regulatory affairs.
- Vaccine regulatory documentation
- .
- Regulatory document drafting and review.
- Technical document assessment.
- Regulatory compliance and the associated
- submission requirements.
- Understanding of global regulatory guidelines.
- Document accuracy, consistency and quality review.
Location & Salary
- Job Location: Not stated in the recruitment notice.
- Salary: Not disclosed by the employer.
Compensat
ion details can be confirmed directly with the Biological E. Limited recruitment team during the application process.
How to Apply for Biological E. Limited Recruitment
Interested and eligible candidates with 5–10 years of relevant Regulatory Affairs experience can apply for the CTD Authoring Specialist – Bio position.
Applicants should have an up to date CV highlighting experience in biologics regulatory affairs, CTD dossier preparation, CTD/eCTD authoring and vaccine related regulatory documentation.
Application Email
Send your updated CV to:
Application Instructions
- Update your resume with relevant Regulatory Affairs experience.
- Highlight
- your hands-on experience in CTD dossier authoring for biologics.
- Mention your experience ofof CTD/eCTD formats and regulatory submissions.
- Include relevant experience in biologics and vaccine regulatory documentation.
- SendJust send your updated CV to the recruitment email address lis
- ted above.plication Deadline: Not specified in the recruitment announcement.
InteInterview details: no interview date or selection schedule has been announced.equently Asked Questions
1. W
hat is the position available at Biological E. Limited?
Biological E. Limited are hiring for the position of Regulatory Affairs – CTD Authoring Specialist – Bio within their Vaccine business.
2. What level of experience is required for this post?
Candidates with 5 to 10 years’ relevant Regulatory Affairs experience are required.
3. Is biologics experience required for this role?
Yes.
The recruitment announcement specifically highlights hands-on experience authoring CTD dossiers for biologics. Experience in biologics and/or vaccine regulatory documentation is also expected.
4. What are the requirements for recruitment with Biological E. Limited
?
The employer haven’t actually specified a mandatory educational qualification in the advert. You’d be expected to have the relevant background in Regulatory Affairs, Pharmaceutical Sciences, Biotechnology or Life Sci
ences.
5. How can applicants apply for this post?
Interested candidates can email their updated CVS to Vaishnavi.Neemkar@biologicale.com.
6. What is the application deadline?
The recruitment announcement does not mention an application deadline. Interested candidates can contact the recruitment team for further information.
Biological E. Limited Recruitment – Job Summary
| Category | Details |
| Company | Biological E. Limited – Vaccine Business |
| Vacancies | Regulatory Affairs – CTD Authoring Specialist – Bio |
| Required Education | Not specified; relevant Pharmaceutical Sciences, Biotechnology or Life Sciences background may be suitable |
| Experience | 5–10 Years |