(BKM) is seeking a Regulatory Affairs Executive to join our team. In this role, you will be responsible for getting new products approv al from the regulated market. In depth knowledge of US FDA, EMA, and ICH regulatory frameworks, eCTD/ACTD dossier preparation, compilation and submission. Familiar with regulatory tools like Extedo, Lorenz, Veeva Vault RIM Job Responsibility:  Prepare, compile, and review CTD/eCTD dossiers for submissions (e.g., ANDA /NDA/MAA)  Coordinate with cross functional teams (QA, QC, R&D, Manufacturing, Packaging) for accurate documentation.  Submit applications to US FDA, EMA, and other authorities in compliance with regional requirements.  Compile and validate submissions using tools such as Extedo, Lorenz docuBridge, or equivalent.  Ensure completeness and technical accuracy of eCTD sequences.  Troubleshoot validation issues before final submission.  Prepare and manage post approval changes (CMC variations, labeling updates, packaging changes).  Submit supplements, amendments, and variations in accordance with regulatory guidelines (FDA’s PAS, EMA's Type IA/IB/II).  Collaborate with internal departments to gather data and draft scientifically sound responses.  Stay updated with changes in FDA, EMA, and ICH guidelines.  Maintain regulatory databases, submission trackers, and approval records.  Participate in audits and support regulatory inspections. Required Qualification & Skills :  Bachelor's / Master’s degree in Pharmacy or related field.  5 10 years of relevant experience in Regulatory Affairs for regulated markets (US/EU)  In depth knowledge of US FDA, EMA, and ICH regulatory frameworks.  Strong understanding of dossier structure, eCTD publishing, and submission timelines. Show more Show less

Major Responsibilities: ● Prospect and identify opportunities to acquire additional business from existing customer base via phone ● Cold call key decision makers for the sales of generic, brand, medical devices and various other product offerings. ● Demonstrate a strong understanding and promote the value and ethics the company ● Achieve customer satisfaction via the phone and appointments while maintaining high standards of customer service. ● Gather data and actively listen to new and existing clients, fully understand their business, uncover their problems and relate to our product offerings. ● Complete associated paperwork following each customer contact in a timely, accurate and legible manner to ensure all details of the transaction are completed according to approved and standardized procedures ● Report daily activity, including contact information, appointments set, follow-ups, etc. Other duties as assigned Requirements: ● Minimum 1 Year of Previous cold calling/telemarketing/ sales experience or internship ● Excellent communication (oral and written and presentation skills) ● Proficiency using MS Office, e.g., PowerPoint, Excel and Word and the internet for research ● Personal drive and internal motivation toward high achievement Ability to work collaboratively and effectively in a team-oriented environment ● Ability to influence, negotiate and gain commitment at all organizational levels ● Demonstrated flexibility and adaptability; willingness to take risks and try new approaches and strong phone presence. Job Type: Full-time Compensation Package: Performance bonus Schedule: Night shift Experience: International voice process: 1 year (Preferred) Business development: 1 year (Required) Cold calling: 1 year (Required) Night Shift: 1 year (Required) Location: Gota, Ahmedabad, Gujarat (Preferred) Work Location: In person

Prepare, compile, and review CTD/eCTD dossiers for submissions (e.g., ANDA /NDA /MAA). Coordinate with cross-functional teams (QA, QC, R&D, Manufacturing, Packaging) for accurate documentation. Submit applications to US FDA, EMA, and other authorities in compliance with regional requirements. Compile and validate submissions using tools such as Extedo, Lorenz docuBridge, or equivalent. Ensure completeness and technical accuracy of eCTD sequences. Troubleshoot validation issues before final submission. Prepare and manage post-approval changes (CMC variations, labeling updates, packaging changes). Submit supplements, amendments, and variations in accordance with regulatory guidelines (FDA’s PAS, EMA's Type IA/IB/II). Collaborate with internal departments to gather data and draft scientifically sound responses. Stay updated with changes in FDA, EMA, and ICH guidelines. Maintain regulatory databases, submission trackers, and approval records. Participate in audits and support regulatory inspections. Job Type: Full-time Pay: ₹30,000.00 - ₹50,000.00 per month Benefits: Paid sick time Paid time off Schedule: Day shift UK shift Application Question(s): Product registration and post licence changes experience in Regulated market must required. Experience: Regulated Market : 3 years (Required) Location: Gota, Ahmedabad, Gujarat (Required) Work Location: In person

Prepare, compile, and review CTD/eCTD dossiers for submissions (e.g., ANDA /NDA /MAA). Coordinate with cross-functional teams (QA, QC, R&D, Manufacturing, Packaging) for accurate documentation. Submit applications to US FDA, EMA, and other authorities in compliance with regional requirements. Compile and validate submissions using tools such as Extedo, Lorenz docuBridge, or equivalent. Ensure completeness and technical accuracy of eCTD sequences. Troubleshoot validation issues before final submission. Prepare and manage post-approval changes (CMC variations, labeling updates, packaging changes). Submit supplements, amendments, and variations in accordance with regulatory guidelines (FDA’s PAS, EMA's Type IA/IB/II). Collaborate with internal departments to gather data and draft scientifically sound responses. Stay updated with changes in FDA, EMA, and ICH guidelines. Maintain regulatory databases, submission trackers, and approval records. Participate in audits and support regulatory inspections. Job Type: Full-time Pay: ₹30,000.00 - ₹50,000.00 per month Benefits: Paid sick time Paid time off Schedule: Day shift UK shift Application Question(s): Product registration and post licence changes experience in Regulated market must required. Experience: Regulated Market : 3 years (Required) Location: Gota, Ahmedabad, Gujarat (Required) Work Location: In person

Job description Recruitment - 70% Core HR Functions - 30% Coordinate and manage the recruiting process, including job posting, screening resumes, conducting interviews, making negotiations and job offers. Facilitate new employee on-boarding, including orientation sessions and completion of necessary paperwork. Prepare and maintain offer letters and contracts. Maintain employee records, both physical and electronic, ensuring accuracy and confidentiality. Maintain employee’s databases. · Maintain and organize administrative files and records. · Prepare HR reports and analytics for management review · Draft and distribute internal communications, memos, and announcements. · Assist in organizing company events, meetings, conferences, or workshops. · Maintain and update HR policies and procedures to ensure always followed. · Identify training needs within the organization and coordinate training programs or workshops · Handle employee inquiries regarding HR policies, benefits, and procedures. · Assist in resolving employee relations issues, conducting investigations, and implementing disciplinary actions when necessary. · Other duties as assigned Skills and Qualifications: Education: A degree in Human Resources Management, Business Administration, or a related field is often required. Experience: Previous experience in HR roles or administrative positions with 2 to 4 years experience. Skills: · Excellent communication and interpersonal skills. · Strong organizational and time management abilities. · Attention to detail and accuracy in work. · Proficiency in HR software and MS Office (Word, Excel, PowerPoint). · Ability to handle sensitive and confidential information with discretion. · Excellent communication (oral and written and presentation skills) Job Type: Full-time Job Type: Full-time Pay: ₹25,000.00 - ₹30,000.00 per month Benefits: Paid sick time Paid time off Schedule: Day shift Fixed shift UK shift Experience: Recruitment: 2 years (Required) HR : 2 years (Preferred) Location: Gota, Ahmedabad, Gujarat (Preferred) Work Location: In person

Job description Recruitment - 70% Core HR Functions - 30% Coordinate and manage the recruiting process, including job posting, screening resumes, conducting interviews, making negotiations and job offers. Facilitate new employee on-boarding, including orientation sessions and completion of necessary paperwork. Prepare and maintain offer letters and contracts. Maintain employee records, both physical and electronic, ensuring accuracy and confidentiality. Maintain employee’s databases. · Maintain and organize administrative files and records. · Prepare HR reports and analytics for management review · Draft and distribute internal communications, memos, and announcements. · Assist in organizing company events, meetings, conferences, or workshops. · Maintain and update HR policies and procedures to ensure always followed. · Identify training needs within the organization and coordinate training programs or workshops · Handle employee inquiries regarding HR policies, benefits, and procedures. · Assist in resolving employee relations issues, conducting investigations, and implementing disciplinary actions when necessary. · Other duties as assigned Skills and Qualifications: Education: A degree in Human Resources Management, Business Administration, or a related field is often required. Experience: Previous experience in HR roles or administrative positions with 2 to 4 years experience. Skills: · Excellent communication and interpersonal skills. · Strong organizational and time management abilities. · Attention to detail and accuracy in work. · Proficiency in HR software and MS Office (Word, Excel, PowerPoint). · Ability to handle sensitive and confidential information with discretion. · Excellent communication (oral and written and presentation skills) Job Type: Full-time Job Type: Full-time Pay: ₹25,000.00 - ₹30,000.00 per month Benefits: Paid sick time Paid time off Schedule: Day shift Fixed shift UK shift Experience: Recruitment: 2 years (Required) HR : 2 years (Preferred) Location: Gota, Ahmedabad, Gujarat (Preferred) Work Location: In person