Regulatory Affairs Executive

This role is for one of the Weekday's clients

Salary range: Rs 600000 - Rs 1100000 (ie INR 6 - 11 LPA)

Min Experience: 6 years

Location: Mumbai

JobType: full-time

We are seeking a detail-oriented and proactive Regulatory Affairs Executive with 6–10 years of experience to join our team. In this role, you will be responsible for ensuring that all products, processes, and operations comply with applicable regulatory requirements across relevant markets. You will act as a key liaison between internal teams and regulatory authorities, helping drive product approvals, maintain compliance, and support business growth through effective regulatory strategies.

Key Responsibilities:

• Develop and implement regulatory strategies to support product development, registration, and commercialization in domestic and international markets.
• Prepare, review, and submit high-quality regulatory dossiers, including applications, amendments, and renewals in accordance with local and global regulatory guidelines.
• Monitor and interpret regulatory requirements, guidelines, and industry trends to ensure ongoing compliance and provide actionable insights to cross-functional teams.
• Liaise with regulatory authorities, addressing queries, responding to deficiencies, and ensuring timely approvals.
• Collaborate with R&D, Quality Assurance, Manufacturing, and Marketing teams to ensure alignment of regulatory requirements throughout the product lifecycle.
• Maintain and update regulatory documentation, including technical files, product labeling, and compliance records.
• Support audits and inspections by regulatory bodies, ensuring readiness and timely closure of observations.
• Assess the regulatory impact of changes in product formulation, manufacturing processes, or labeling, and guide teams on necessary actions.
• Provide training and guidance to internal stakeholders on regulatory policies, procedures, and best practices.
• Ensure compliance with post-market surveillance requirements, including adverse event reporting and product recalls, if necessary.

Key Skills & Competencies:

• Strong expertise in Regulatory Affairs, with a deep understanding of global regulatory frameworks and submission processes.
• Proven experience in managing end-to-end regulatory submissions and approvals.
• Excellent knowledge of documentation standards, technical writing, and regulatory compliance requirements.
• Ability to interpret complex regulations and translate them into practical business actions.
• Strong communication and stakeholder management skills, with experience interacting with regulatory authorities.
• High attention to detail, with a structured and analytical approach to problem-solving.
• Ability to manage multiple projects simultaneously and meet tight deadlines in a fast-paced environment.
• Proficiency in regulatory information management systems and documentation tools.

Qualifications:

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, or a related field.
• Certification or specialization in Regulatory Affairs is an added advantage.