9 Regulated Market Jobs

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 products. 9. Should have knowledge on product development requirements for Regulated market (EU/UK/Canada). 10. Should have knowledge on QbD and DOE, formulation development and Process development of drug products. 11. Coordination with CFTs like: DQA, Clinicals, Regulatory, Technology transfer and production for smooth development and transfer of product from laboratory to Production floor. 12. Knowledge on IR/MR solid oral drug products. Preferred candidate profile Male candidate only

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 and market trends Ability to manage partnerships, alliances and collaborations Comfortable using tools like Excel, PowerPoint, for data driven decision making, analytical thinking Analytical skills, Familiarity with databases for business intelligence Ability to forecast sales and assess market entry risks Critical thinking to evaluate opportunities from commercial and technical perspective.

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 Indian NRA applications (Eg: Form CT 10, 16, CT18, 40, 10, Export NoC, etc., but not limited) Well versed with Indian NRA submission portals, IBKP, SUGAM, NSWS, ODLS/ ONDLS, etc. Author, review and compilation of Regulatory Packages like Briefing documents, Scientific package, Pre-IND packages, Clinical Trial, Expedited request, Pre-qualifications, etc. Author, review, compile and submission of Marketing Authorization Applications (CTD/ ACTD/ eCTD) in India, Emerging Markets, Regulated Markets and Vaccine Prequalification Dossier to WHO. Application for Post Approval Change(s), Variations and Comparability packages Author, review and submission of responses to India, EM, WHO and Regulated markets.. Hands-on experience with MS office tools, PDF, Track Wise, DMS, Veeva Vault, Lorenz/ Pharma ready, etc.. Handling the Health Agency audits for India, EM, Regulated and WHO inspections Coordination with cross functional departments like QA, QC, Production, Warehouse, Distribution, Marketing and various teams (Internal & External). Review of Artworks (Labels and Package Insert) and Pack Profiles. Any other regulatory support required by the organization per submission need. Interested Candidates having relevant experience can send in their CVs to HR.Intern4@biologicale.com by mention the subject as Applying for "Regulatory Affairs"

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. Coordination with different cross functional team like ADL, IP, Project Management, SCM, Clinical and regulatory for smooth execution of the projects. 7. Execution of Tech Transfer and monitoring scale up / Exhibit batches. 8. Having well verse knowledge on Regulatory Guidelines for EU, Canada and TGA 9. Lab activities and team management experience is must. Preferred candidate profile Team Management, Formulation Development, Scale Up and Technology Transfer

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

We are looking for Regulatory Affairs - Officer / Sr. Officer handling Reg, CIS, 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 regulatory insights to internal teams on best practices for data management and documentation. 4. Documentation and Record Keeping: Maintain well-organized records of submissions, communications, and approvals. Use regulatory software and systems for document tracking, version control, and report generation. Education: B pharm and MBA (Preferred) Desirable Skills & Competencies: Strong communication skills for effective client and team interactions. Excellent negotiation skills to close profitable deals. Strategic thinking for market expansion and business growt Interested candidates can apply or mail your resume. If you have good references you can share - Thanks & Regards, Vaibhavi Behere HR Department Titan Laboratories Pvt Ltd vaibhavi.b@titanpharma.com

Company Name- Exemed Pharmaceuticals Business - Pharma API - Domestic Market Location - Mumbai (Marketing Office )/ Vadodara (Corporate Office) (Open) Exp - 10 to 15 years We are seeking an enthusiastic and driven Manager/Senior Manager in Business Development (API)- Domestic Markets to join our team. The role is based in Kandivali West, Mumbai/ Or 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 Engagement: Foster meaningful interactions with key stakeholders, focusing on removing access barriers for valued customers. Relationship Building: Establish and nurture partnerships with high-value customers through strategic engagement and communication. Solution Development: Provide innovative API solutions and ensure smooth handover to the sales operations team after three successful transactions. Market Access Initiatives: Lead and coordinate these initiatives by collaborating with internal and external partners. Communication Excellence: Showcase professional communication skills, especially in English. Entrepreneurial Mindset: Embrace innovation, challenge norms, and maintain proactive, adaptable qualities. Project Management: Possess strong leadership and project management skills to handle diverse projects effectively. Interpersonal Skills: Build relationships with a broad range of stakeholders, from technical experts to business leaders. Candidate Requirements: Experience: 815 years in Market Access, Marketing, or Sales within the API industry. Education: Bachelor’s degree in Pharmacy (B.Pharm) or Science (B.Sc.) and an MBA in Marketing. Proven Success: Track record of generating new business leads and creating a unique product pipeline that sets the organization apart. If you’re a dynamic and resourceful professional ready to make an impact in a growing pharmaceutical company, we’d love to hear from you. Please share your resume if interested.

Dear Candidates, Greetings of the day! Harman Finochem Limited is an India-based Pharmaceutical Company catering to its clients across the globe, established by Late Mr. Bhupinder Singh Manhas in 1983, our core competencies are in manufacturing and exporting of Active Pharmaceutical Ingredients mainly Metformin HCl, Fenofibrate, Divalproex Sodium, Riboflavin Phosphate Sodium, Glycopyrrolate/Glycopyrronium bromide and more. We have two USFDA approved manufacturing facilities at Shendra & Chikalthana, Aurangabad. We are hiring for "Regulatory Head - API Division" for Shendra, Aurangabad location, who will be responsible for three API units. Role & responsibilities : 1. Responsible to review and submission of DMFs/E-DMFs/CEPs to US-FDA, Europe, EDQM, Health Canada, PMDA, China, Korea, Brazil and Rest of World. 2. Ensuring timely readiness of dossiers for all submissions. 3. Co-ordination with other departments to resolve the issues and queries related to submitted dossiers. 4. Quality and speedy response to the Regulatory agencies queries and Customer queries. 5. Conduct training on DMF compilation, submission and guidelines to build regulatory team of well-rounded professionals 6. Evaluation of manufacturers of staring material & primary packing material for use in Active Pharmaceuticals Ingredient. 7. Monitoring and communicating new and changing regulations to concern Department. 8. Maintenance of DMF fees and facility fees (self-identification) in accordance to GDUFA Evaluation of change controls and other documents. 9. Maintaining self-identification of our facilities & establishment renewal to US FDA. 10. Review and submission to drug listing (Label) of our API to US-FDA. 11. Maintaining the D&B renewal for our facilities. 12. Maintaining the life cycle of submitted DMFs, annual-updates, amendments and variation filings as per the stipulated timeline. Preferred candidate profile : Education : BSc/MSc Experience : 16 to 25yrs of experience in API Pharma Industry into Regulated market Good in Team Management Perks and benefits : As per company standard