81 Pharmaceuticals jobs in Ahmedabad

• Prepare and submit regulatory submissions (e.g., CTD, ANDA, NDA) to health authorities.
• Manage product registrations and renewals in various target markets.
• Ensure compliance with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP).
• Monitor and interpret regulatory guidelines and advise the company on their impact.
• Liaise with national and international regulatory agencies on behalf of the company.
• Review and approve labeling, promotional materials, and advertising for regulatory compliance.
• Provide regulatory support for product development, clinical trials, and post-marketing activities.
• Conduct regulatory intelligence gathering and risk assessments.
• Collaborate with R&D, quality assurance, manufacturing, and marketing departments.

• Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
• Minimum of 6 years of experience in regulatory affairs within the pharmaceutical industry.
• Proven experience in preparing and submitting regulatory dossiers for various product types.
• In-depth knowledge of pharmaceutical regulations in key markets (e.g., India, US FDA, EMA).
• Strong understanding of drug development processes and lifecycle management.
• Excellent written and verbal communication skills.
• Meticulous attention to detail and strong organizational skills.
• Ability to work independently and manage multiple projects simultaneously.
• Proficiency in regulatory affairs management systems and databases.

• Develop and implement regulatory strategies for new drug applications (NDAs), variations, and post-approval changes across various global markets.
• Prepare, review, and compile high-quality regulatory submission documents (e.g., CTD modules, INDs, MAAs).
• Liaise directly with regulatory health authorities (e.g., FDA, EMA, CDSCO) for submissions, inquiries, and meetings.
• Ensure all regulatory activities are conducted in compliance with relevant regulations, guidelines, and company policies.
• Provide regulatory guidance and support to R&D, clinical, manufacturing, and marketing teams.
• Maintain regulatory databases and tracking systems for submissions, approvals, and compliance.
• Monitor and assess the impact of new and evolving regulations on the company's products and strategies.
• Manage responses to regulatory agency questions and deficiency letters.
• Participate in regulatory inspections and audits.
• Contribute to the development and improvement of internal regulatory processes and SOPs.
• Conduct due diligence for potential business development opportunities from a regulatory perspective.

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biotechnology, or a related life science discipline. A Ph.D. is a plus.
• Minimum of 5-8 years of progressive experience in pharmaceutical regulatory affairs.
• Proven experience in preparing and submitting successful regulatory dossiers for various regions (e.g., US, EU, India).
• In-depth knowledge of drug development processes and regulatory requirements for different dosage forms.
• Familiarity with ICH guidelines and regional regulatory frameworks.
• Excellent written and verbal communication skills, with a strong command of scientific and regulatory terminology.
• Strong analytical and problem-solving abilities.
• Meticulous attention to detail and organizational skills.
• Ability to manage multiple projects simultaneously and meet tight deadlines.
• Experience working with cross-functional teams.
• Proficiency in regulatory information management (RIM) systems is desirable.

• Develop and execute global regulatory strategies for new and existing pharmaceutical products.
• Prepare, review, and submit regulatory dossiers (e.g., INDs, NDAs, MAAs, CTDs) to health authorities worldwide.
• Interpret and apply complex regulatory guidelines and ensure compliance.
• Liaise effectively with regulatory agencies, health authorities, and internal stakeholders.
• Manage the lifecycle of regulatory submissions and respond to agency inquiries.
• Provide regulatory guidance and support to R&D, manufacturing, and commercial teams.
• Assess the regulatory implications of product changes and manufacturing processes.
• Monitor and evaluate changes in the global regulatory landscape.
• Develop and maintain regulatory documentation and databases.
• Contribute to the development of regulatory policies and procedures.
• Conduct regulatory intelligence activities to identify emerging trends and requirements.
• Participate in regulatory inspections and audits.
• Lead or support cross-functional teams on regulatory matters.
• Ensure timely approval of marketing authorizations and post-approval variations.
• Advise on labeling requirements and promotional material compliance.

• Conducting in-vitro and in-vivo experiments to evaluate the efficacy and safety of potential drug candidates.
• Designing and executing complex experiments, analyzing data, and interpreting results in the context of drug discovery objectives.
• Developing and validating new assays and methodologies to support research programs.
• Maintaining accurate and detailed laboratory notebooks and contributing to the preparation of scientific reports and publications.
• Collaborating with cross-functional teams, including chemists, biologists, and toxicologists, to advance research projects.
• Staying current with scientific literature and emerging trends in pharmaceutical research and development.
• Operating and maintaining sophisticated laboratory equipment.
• Adhering to all safety protocols and laboratory procedures.
• Presenting research findings at internal meetings and potentially at scientific conferences.
• Contributing to the intellectual property strategy through patent filings.

About Us:

Duowei Medical Group is a comprehensive enterprise specializing in the pharmaceutical and chemical industries. Established in 1996, after nearly 30 years of stable development, the group's business portfolio encompasses agrochemicals, active pharmaceutical ingredients (APIs), bio-organic fertilizers, healthcare products, human pharmaceutical preparations, as well as animal nutrition and pet products.

Currently, the group is formulating strategic plans to expand its business footprint into more international markets, including India, North America, and the majority of European countries.

We are actively seeking highly motivated and talented individuals who are passionate about driving business growth, achieving sales target, enhancing international sales performance, and acquiring new clients on a global scale.

Working Locations

• Office-based positions in Hong Kong
• Remote positions in India, the USA, and European countries

General Purpose:

This integral role is to identify and qualify new business leads for the company. Lead generation is critical to the growth of Duowei Medical Group, and the prospective candidate will be at the forefront of business development and the sales cycle.

Essential Duties & Responsibilities

• Identifying potential customers and prospects
• Formulate, manage and execute sales plan with sales team Generate Leads, making cold call to introduce Duowei and its products
• Daily progress reports
• Work on lead generation campaigns i.e. seminars and pre-conference meeting out reach
• Responsible for the sales of all company products including but not limited to animal medicine preparations, pesticides, vitamins, and raw materials for human medicine in the company
• Develop new customers and maintain relationships with existing customers
• Expand international markets through multiple channels, optimize customer service systems, and enhance customer satisfaction
• Conduct market research and analysis: collect industry trends, competitor information, customer voice and needs, develop market strategies and adjust sales plans
• Make first contact with inbound leads and secure follow up meetings
• Attend seminars and conferences in certain regions around the globe

Minimum Requirements

• University degree, preferably in business/marketing/pharmaceutical/chemistry related
• More than 2 years sales experience in related Active Pharmaceutical Ingredients including: pesticide, veterinary drug.
• Experience in cold calling
• Must be tenacious and hungry to succeed and generate sales

About Us:

Duowei Medical Group is a comprehensive enterprise specializing in the pharmaceutical and chemical industries. Established in 1996, after nearly 30 years of stable development, the group's business portfolio encompasses agrochemicals, active pharmaceutical ingredients (APIs), bio-organic fertilizers, healthcare products, human pharmaceutical preparations, as well as animal nutrition and pet products.

Currently, the group is formulating strategic plans to expand its business footprint into more international markets, including India, North America, and the majority of European countries.

We are actively seeking highly motivated and talented individuals who are passionate about driving business growth, achieving sales target, enhancing international sales performance, and acquiring new clients on a global scale.

Working Locations

• Office-based positions in Hong Kong
• Remote positions in India, the USA, and European countries

General Purpose:

This integral role is to identify and qualify new business leads for the company. Lead generation is critical to the growth of Duowei Medical Group, and the prospective candidate will be at the forefront of business development and the sales cycle.

Essential Duties & Responsibilities

• Identifying potential customers and prospects
• Formulate, manage and execute sales plan with sales team Generate Leads, making cold call to introduce Duowei and its products
• Daily progress reports
• Work on lead generation campaigns i.e. seminars and pre-conference meeting out reach
• Responsible for the sales of all company products including but not limited to animal medicine preparations, pesticides, vitamins, and raw materials for human medicine in the company
• Develop new customers and maintain relationships with existing customers
• Expand international markets through multiple channels, optimize customer service systems, and enhance customer satisfaction
• Conduct market research and analysis: collect industry trends, competitor information, customer voice and needs, develop market strategies and adjust sales plans
• Make first contact with inbound leads and secure follow up meetings
• Attend seminars and conferences in certain regions around the globe

Minimum Requirements

• University degree, preferably in business/marketing/pharmaceutical/chemistry related
• More than 2 years sales experience in related Active Pharmaceutical Ingredients including: pesticide, veterinary drug.
• Experience in cold calling
• Must be tenacious and hungry to succeed and generate sales