Senior Regulatory Affairs Specialist

6 days ago


Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 20,00,000

Main Purpose

Drive business growth by overseeing the regulatory affairs function.

This involves working under limited supervision to apply subject matter knowledge in the area of Regulatory Affairs.

Requires capacity to apply skills/knowledge within the context of specific needs or requirements.

Main Responsibilities

Direct development of product registration submissions, progress reports, supplements, amendments, or periodic experience reports.

Interact with regulatory agencies to expedite approval of pending registrations.

Serve as regulatory liaison throughout the product lifecycle.

Participate in product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).

Ensure timely approval of new drugs, biologics, or medical devices and continued approval of marketed products.

Serve as regulatory representative to marketing, research teams, and regulatory agencies.

Advise on manufacturing changes, line extensions, technical labeling, appropriate regulations, and interpretations.

Qualifications

Associate Degree (13 years)



  • Mumbai, Maharashtra, India beBeeCompliance Full time ₹ 30,00,000 - ₹ 50,00,000

    Job Title: Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our Portfolio Management Services team. The successful candidate will be responsible for ensuring that all activities align with relevant regulatory frameworks and internal guidelines.The ideal candidate will possess a strong academic background,...


  • Mumbai, Maharashtra, India beBeeRegulatoryAffairs Full time ₹ 90,00,000 - ₹ 1,50,00,000

    Regulatory Affairs SpecialistMain Purpose of Role:We are seeking a highly experienced and knowledgeable Regulatory Affairs Specialist to join our team. The ideal candidate will have comprehensive knowledge in the area of Regulatory Affairs and be able to execute complex projects.The Regulatory Affairs Specialist will direct the development of product...


  • Mumbai, Maharashtra, India beBeeRegulatoryAffairs Full time ₹ 15,00,000 - ₹ 30,00,000

    Job OverviewThe Manager of Regulatory Affairs will be a specialist professional with comprehensive knowledge in the area of regulatory affairs.Main Responsibilities:Develop and manage product registration submissions, progress reports, supplements, amendments, or periodic experience reports as a highly experienced and knowledgeable resource within the...


  • Mumbai, Maharashtra, India beBeeRegulatoryAffairs Full time ₹ 1,04,000 - ₹ 1,30,878

    Job Overview:">Lead Consultant - Regulatory Affairs Specialist. At our company, we are seeking an experienced and skilled professional to support our clients in regulatory affairs. The ideal candidate will have a strong background in chemistry, manufacturing, and controls (CMC) with excellent analytical and problem-solving skills.">The role involves...


  • Mumbai, Maharashtra, India beBeePharmaceutical Full time ₹ 1,04,000 - ₹ 1,30,878

    As a qualified professional in the pharmaceutical industry, we are seeking an experienced individual to take on the role of Regulatory Affairs Specialist. The ideal candidate will have a strong understanding of various pharmacopoeias and regulations.The responsibilities of this position include:


  • Mumbai, Maharashtra, India beBeeRegulatoryAffairs Full time ₹ 15,00,000 - ₹ 25,00,000

    Regulatory Affairs SpecialistMain Purpose of Role:The Regulatory Affairs Specialist will be a key contributor to the development and implementation of regulatory strategies for our products.This role requires an individual with comprehensive knowledge in the area of Regulatory Affairs, who can execute highly complex or specialized projects, and adapt...


  • Mumbai, Maharashtra, India beBeeCompliance Full time ₹ 12,00,000 - ₹ 18,00,000

    Regulatory affairs specialists play a vital role in ensuring compliance with regulatory requirements and facilitating the smooth operation of businesses.This position requires an individual with expertise in regulatory affairs, including experience with eCTD software and e-publishing requirements throughout the project lifecycle. The ideal candidate will...


  • Mumbai, Maharashtra, India beBeeRegulatoryAffairs Full time US$ 80,000 - US$ 1,20,000

    About Our Senior Regulatory Affairs RoleWe are seeking an experienced Senior Executive to join our team in a pivotal regulatory affairs function, overseeing finished dosage form products.Lead the development and review of product dossiers, ensuring compliance with regulatory requirements.Conduct thorough gap analyses to identify areas for improvement and...


  • Mumbai, Maharashtra, India Chemical Manufacturing Full time

    Job Title: Senior Executive / Assistant Manager – Regulatory Affairs Location: Mumbai, India (On-site) Employment Type: Full-time | Permanent Experience Required: 3 to 8 years Industry: Chemicals | Pharmaceuticals | Food & Beverages Job Function: Legal | Quality Assurance | Regulatory Affairs Salary: up to 9 LPA About the Role: We are hiring for...


  • Mumbai, Maharashtra, India Tek Support Full time ₹ 1,04,000 - ₹ 1,30,878 per year

    Job Title:Regulatory Affairs Specialist Med/Pharma (Female)Location:RemotePosition Overview:We are seeking an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring...