22 Regulated Market Jobs

Regulatory Affairs Job Opportunity! Desired Experience : 5- 11 years Job Location : Genome Valley, Shameerpet, Hyderabad Preferred Industry : Vaccines / Biotech Designation: Senior Executive/ Assistant Manager Qualification: M. Pharmacy/ M. Sc/ B. Pharmacy Job Responsibilities: Responsible for Preparation of Regulatory Documents for submission to Indian Regulatory Authorities. Experienced in handling, management and expansion of product portfolios, markets/ territories. Experienced in the preparation, review and submission of applications/ response to RCGM vide IBSC. Expertise in preparation, compilation and submission of Indian NRA applications (Eg: Form CT 10, 16, CT18, 40, 10, Export NoC,...

As a Procurement Manager for an OSD manufacturing plant and R&D facilities, your role will involve managing procurement activities for two locations around Ahmedabad. Your key responsibilities will include: - Identifying and negotiating with vendors for quality API, Excipients, Packaging materials, and consumables for the manufacturing plant and R&D facilities To excel in this role, you should possess the following qualifications: - Graduate with requisite experience in procurement of materials for an oral solid manufacturing plant targeted for the regulated market - Excellent verbal and written communication skills along with a well-established network of contacts in the industry - Hands-on...

Company Name- Exemed Pharmaceuticals Business - Pharma API - Domestic Market Location - Vadodara (Corporate Office) (Open) Exp - 3 to 8 Years We are seeking an enthusiastic and driven Executives/Sr.Executive/AM in Business Development (API)- Domestic Markets to join our team. The role is based in Vadodara based Corporate office , and is ideal for candidates experienced in market access, marketing, or sales within the API industry. If youre interested and ready to relocate, please share your updated resume along with required details in attached format. Key Responsibilities: API Market Expertise: Leverage your expertise to drive growth in regulated and non-regulated markets. Stakeholder Engag...

Experience in Solid Oral Dosage & Liquid Orals form in Formulation & Development Dept. for Regulated Market. Required Candidate profile Candidates should have 4-8 Years of relevant experience.

-Formulation of trials for solid, liquid and semisolid formulations -To perform literature search & preparation of literature survey report -Execution of formulated/ Design trials and sample order batches -Preparation of R&D Departmental SOPs Required Candidate profile -To maintain GLP and GMP in the laboratory -Preparation & review of Technology Transfer Document and other relevant documents -To involve in scale-up and initial commercial batches preparation

1.Experience in Regulated Market (US, Europe) 2.Candidate should perform literature search 3.Should have some basic understanding of patent and generic formulation development. 4.Characterization of marketed product wrt market requirements Required Candidate profile 5.Knowledge of ICH stability conditions and compilation of analytical data 6.Preparation of various documents like PDR, stability protocol, development report writing FDR/PDR

Regulatory Affairs Job Opportunity! Desired Experience : 3- 9 years Job Location : Genome Valley, Shameerpet, Hyderabad Preferred Industry : Vaccines / Biotech Designation: Senior Executive/ Executive Qualification: M. Pharmacy/ M. Sc/ B. Pharmacy Job Responsibilities: Responsible for Regulatory submission to Indian NRA, Emerging Markets, Regulated Markets and World Health Organization. Experienced in handling, management and expansion of product portfolios, markets/ territories. Experienced in the preparation, review and submission of applications/ response to RCGM vide IBSC. Expertise in preparation, compilation and submission of Indian NRA applications (Eg: Form CT 10, 16, CT18, 40, 10, E...

The AGM / DGM Technical Services position requires a candidate with a B.Pharma / M.Pharma qualification and 15 to 20 years of experience in tech transfer activities of solid oral dosage forms for regulated markets. The ideal candidate should have experience in managing a team of 15 to 20 scientists, documentation officers, and technicians. As an AGM / DGM Technical Services in Kandivali, Mumbai, your responsibilities will include planning and executing scale-up and Exhibit batches of solid oral dosage forms for regulated markets such as US, EU, ROW, and Canada. You will be accountable for ensuring the timely initiation of stability studies for exhibit batches and overseeing the technical ser...

We are looking for Regulatory Affairs - Executive / Sr. Executive handling Africa and Asia and will be based at Juinagar, Navi Mumbai. Minimum 5 Years in RA is must Roles & Responsibilities: 1. Dossier Preparation and Submission: Compile and review regulatory submissions in ACTD, CTD and formats. Ensure all regulatory documents are accurate, complete, and compliant with regulatory requirements. 2. Review of Plant and R&D Data: Review R&D data to confirm compliance with regulatory expectations and assist in developing effective submission strategies. 3. Regulatory Compliance and Updates: Stay informed of changes in Asian and CIS market regulations, ensuring timely implementation of updates to...

As a Formulation and Development Officer for our client based in Vatva, Gujarat, you will be responsible for various key tasks. Your primary duty will involve the development of formulations for all dosage forms such as tablets, capsules, ointments, creams, gels, oral liquids, injectables, and novel drug delivery systems for different markets including regulated, domestic, and ROW markets. This includes activities like document review, planning, and conducting stability studies of R&D batches. Additionally, you will be required to provide technical support for the scale-up and technology transfer to manufacturing processes. You will play a crucial role in troubleshooting formulation-related ...

Looking candidates for PDR (Formulation & Development ) Dept. 5-10 years of relevant experience in solid oral dosage (Regulated Market US & Europe) Roles and Responsibilities 1.Candidate should perform literature search 2.Pre formulation development Required Candidate profile 1.knowledge of documents – Master formula card, Bill of Material, stability protocol 2.Preparation of various documents like PDR, stability protocol, development report writing FDR/PDR

Designation : AGM / DGM - Formulation & Development. Qualification : M. Pharma / PhD. Experience : 15 to 20 yrs of experience in Formulation & development of Ophthalmic / Liquid oral dosage form for Regulated Market. Must have filed 10-15 products for US/EU market. Team handling,

Role & responsibilities Strategizing the Biosimilar process development based on CHO & other mammalian cells lines for developing non-infringing Upstream process. Understanding the cell Lines, cell culture & Bioreactor process based biotherapeutic proteins development towards submission in India & various regulated countries. Good knowledge of Cell line development & cell line characterization. Understanding developmental requirements for India, ROW & regulated market (Phase-I & III) and their fulfilment during development of respective geographies. Planning and execution of experiments as part of process development, Upstream activities at shake flask and Bioreactor stages for recombinant m...

Department: R&D Biotech (Downstream Process) at Airoli, Navi Mumbai Role: Downstream Process & Formulation development Opportunity: This role provides an opportunity to learn and grow to an advance level of expert in the field of downstream processing & formulation development of Recombinant Biotherapeutics Proteins. Role & responsibilities Development of non-infringing downstream purification process for cell culture based biotherapeutic proteins towards submission in India & various regulated countries. Understanding developmental requirements for India, ROW & regulated market (Phase-I & III) and their fulfilment during development of respective geographies. Responsible for end-to-end proc...

We are looking for Regulatory Affairs - Executive / Sr. Executive handling Africa and Asia and will be based at Juinagar, Navi Mumbai. Roles & Responsibilities: 1. Dossier Preparation and Submission: Compile and review regulatory submissions in ACTD, CTD and formats. Ensure all regulatory documents are accurate, complete, and compliant with regulatory requirements. 2. Review of Plant and R&D Data: Review R&D data to confirm compliance with regulatory expectations and assist in developing effective submission strategies. 3. Regulatory Compliance and Updates: Stay informed of changes in Asian and CIS market regulations, ensuring timely implementation of updates to maintain compliance. Provide ...

Role & responsibilities Senior Manager Drug Regulatory Affairs will lead regulatory strategy and operations for injectable pharmaceutical products targeted at regulated markets ( EU, Canada, Australia). This role is responsible for managing end-to-end regulatory submissions. Ensuring compliance with regional requirements, and coordinating with cross-functional teams including R&D, Quality, Manufacturing, and external partners to support product development and lifecycle management. Key Responsibilities: 1. Regulatory Strategy & Submissions: Develop and implement regulatory strategies for the injectable products for regulated markets. Oversee preparation, review, and submission of high-qualit...

Role & responsibilities 1. Literature Search, Pharmacopoeia and Patent Search, Review and Discussion and Documentation. 2. Application of NOC, Test License, Manufacturing and Import License 3. Reference product Characterization, Manufacturing and Import License. 4. Reference product Characterization, Reverse Engineering and prototype development. 5. Preformulation study, Manufacturing of bench scale trials for formulation development. 6. Manufacturing of process optimization batches, scale up batches and submission batches. 7. Preparation of Bill of Material, Master Formula Record for manufacturing of submission batches. 8. Preparation of Product development Report for regulatory filing of p...

Greetings from Encube Ethicals Pvt. Ltd. We are looking for Sr. Manager Business Development Please find below brief details of the Company profiles and job description for your reference. Key Deliverables Identifying new BD leads for CDMO Business. RFQ preparation Contract negotiation Market research and portfolio review Costing & Business case preparation Communication with internal & external stakeholders Presentations for MIS and Business review Customer Management Cost analysis and change order preparation Project Tracking Skills Required Excellent communication skills, relationship management with internal & external stakeholders Understanding of drug development, regulatory processes ...

Regulatory Affairs Job Opportunity! Desired Experience : 3- 15 years Job Location : Genome Valley, Shameerpet, Hyderabad Preferred Industry : Vaccines / Biotech Designation: Senior Manager/ Manager/ Deputy Manager/ Assistant Manager/ Senior Executive/ Executive Qualification: M. Pharmacy/ M. Sc/ B. Pharmacy Job Responsibilities: Responsible for Regulatory submission to Indian NRA, Emerging Markets, Regulated Markets and World Health Organization. Experienced in handling, management and expansion of product portfolios, markets/ territories. Experienced in the preparation, review and submission of applications/ response to RCGM vide IBSC. Expertise in preparation, compilation and submission of...

Role & responsibilities 1. Responsible to lead a team of 4-5 scientist for the development of drug products of Regulated Market (EU and UK) 2. Responsible for drug product development to exhibit batch execution and to support for regulatory filing. 3. Conduct Literature survey and compile the scientific data per product. Development of Rubust, bioequivalent formulation and processes through optimization by applying QbD principles. 4. Compilation and review of developmental data and exhibit batch stability data. 5. Should have good understanding on Reference Product Characterization, reverse Engineering, Bioequivalent Prototype development, Stability studies, Scale up activities. 6. Coordinat...

1. Business Development Specialist - Pharma (Global Regulated Markets) Identify, assess, and pursue new business opportunities (in-licensing, out-licensing, strategic alliances) for pharmaceutical products. Collaborate cross-functionally with R&D, Regulatory, Legal, and Commercial teams. Strong understanding of pharma regulatory pathways and market access. 2. Regulatory Affairs (Both Regulated and Non-Regulated Market) : Develop and implement comprehensive regulatory strategies for new product development, lifecycle management, and post-market activities for various pharmaceutical dosage forms (e.g., tablets, capsules, injectables).

Good understanding on formulation & Development for regulated market/Should have experience on product technology transfer at plant side/ Knowledge on QBD,Good documentation practice/literature survey/ICH guidelines/ Solid Oral/Injectables/ OSD Required Candidate profile Execution of process evaluation, optimization, scale-up and exhibit batches. Meeting product development timelines/ Solid Oral/ Injectable Candidate can share their CV on stuti.naik@enaltec.com