Regulatory Affairs and Safety Associate

Reckitt Benckiser Pakistan Ltd

Islamabad , Pakistan

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Reckitt is a global leader in hygiene, health, and nutrition, committed to creating a cleaner and healthier world. Our Research & Development team includes skilled scientists, engineers, medical, clinical, and regulatory professionals who drive innovation through nine Centres of Excellence. We focus on developing and improving our product portfolio with the highest standards of quality and integrity. Joining Reckitt offers a dynamic work environment with opportunities for growth across various R&D functions and access to our dedicated Research and Development Academy.

Key Responsibilities
Manage all internal Regulatory and Government Affairs functions, including submissions and acknowledgments of NDAs, variations, renewals, regulatory intelligence, and CARA updates. Support the Regulatory Affairs Manager by delivering strategic and innovative regulatory solutions that facilitate business growth and ensure compliance. Oversee product registrations, renewals, and legal compliance in accordance with local regulatory legislation. Advise and coordinate approvals for product and manufacturing site changes. Implement, maintain, and update Reckitt Pakistan’s regulatory affairs processes to comply with local laws and regulations. Collect and analyze regulatory information to provide strategic insights for timely decision-making. Stay informed about the company’s product range and evaluate complex regulatory information. Provide immediate strategic advice on regulatory rules affecting local business in alignment with the Regulatory Affairs Manager. Resolve complex regulatory issues and prepare necessary documentation. Review company practices and recommend system improvements. Liaise with regulatory authorities, including conducting presentations and negotiations to resolve issues and secure approvals. Submit licensing and clinical trial applications, as well as pharmacovigilance reports, within required timelines. Manage all registration activities and negotiate with authorities on product registration and price fixation. Maintain regular communication with regulatory bodies and company headquarters. Provide regulatory input to management to support product development planning and ensure timely approvals. Conduct quarterly visits to PSQCA and PFA for renewals and issue resolution. Upload all products, both regulated and non-regulated, onto CARA and manage local regulatory intelligence updates. Assist the Regulatory Affairs Manager with matters involving other government departments and ministries as needed.

Required Qualifications
Bachelor’s degree in Pharmacy, Human Sciences, Chemistry, Human Biology, Biochemistry, Veterinary Science, or Medicine. A minimum of 3-4 years’ experience in OTC, FMCG, or pharmaceutical sectors, with exposure to regulatory affairs, safety, sales, trade marketing, or marketing roles. Comprehensive knowledge of Pakistan’s regulatory and healthcare systems.

Preferred Qualifications and Benefits
Strong commercial awareness, business partnership skills, collaboration, dossier writing, product lifecycle management, and the ability to challenge the status quo. Demonstrated accountability, adaptability, objective setting, and business strategy skills. Reckitt promotes an inclusive culture supported by global Employee Resource Groups and invests in employee wellbeing through parental benefits, mental health programs, and life insurance. Additional benefits align with local market standards and include global share plans and short-term incentives for eligible roles. Reckitt is committed to equal opportunity employment and encourages candidates who may not meet every criterion but demonstrate potential and alignment with our values to apply.

At Reckitt, we value diverse backgrounds and experiences. If this role excites you and you share our purpose, we welcome your application.