Drug Regulatory Affairs MEDYUR PHARMACEUTICALS LIMITED

About MEDYUR PHARMACEUTICALS LIMITED

Job Description

We are seeking a detail-oriented Drug Regulatory Affairs Specialist to join our dynamic team at MEDYUR PHARMACEUTICALS LIMITED. In this role, you will play a crucial part in ensuring compliance with regulatory requirements for our products while collaborating closely with cross-functional teams to drive successful product launches and maintain regulatory compliance. Responsibilities Prepare and submit regulatory documentation such as dossiers, including pre-market submissions, to regulatory authorities to obtain necessary approvals. Ensure compliance with current regulatory requirements by staying up to date on regulations, guidelines, and industry trends in global markets. Develop and maintain strong relationships with regulatory bodies to facilitate smooth communication and approvals. Review and assess changes to regulatory policies and recommend actions to ensure continued compliance. Conduct regulatory impact assessments to evaluate potential changes in regulations or market conditions that could affect product development or commercialization. Maintain regulatory files, records, and reports in accordance with internal and external requirements. Support regulatory inspections and audits by providing necessary documentation and expertise. Collaborate with product development, quality assurance, and marketing teams to develop regulatory strategies that align with business goals. Serve as the primary point of contact for regulatory agency inquiries and facilitate communication between the agency and internal stakeholders. Required and Preferred Qualifications Required: Bachelor's degree in Life Sciences, Regulatory Affairs, or a related field. Minimum of 2-8 years of experience in regulatory affairs within the healthcare or pharmaceutical industry. In-depth knowledge of regulatory requirements and guidelines . Strong analytical skills with the ability to interpret complex regulatory documents and data. Preferred: Master's degree in a relevant field. Experience with medicines and formulations products. Technical Skills and Relevant Technologies Proficiency in regulatory submission software and electronic document management systems. Strong understanding of risk management principles and methodologies. Familiarity with project management tools and techniques to ensure timely delivery of regulatory submissions. Soft Skills and Cultural Fit Exceptional verbal and written communication skills, with the ability to convey complex regulatory concepts to diverse audiences. Strong organizational skills and attention to detail, ensuring accuracy in regulatory submissions. A proactive approach and ability to work independently, as well as collaboratively within a team environment. Adaptability and resilience in a fast-paced, evolving regulatory landscape. Job Types: Full-time, Permanent Benefits: Cell phone reimbursement Internet reimbursement Schedule: Day shift Performance bonus Ability to commute/relocate: Faridabad, Haryana: Reliably commute or planning to relocate before starting work (Preferred) Experience: Drug regulatory affairs: 2 years (Required) Language: English (Preferred) Work Location: In person,