Head of RAS
We are Reckitt
Research & Development
We do the right thing, always, by ensuring we act with responsibility and integrity, by complying with regulatory legislation across the globe, whilst ensuring our products are safe for our consumers and are to the highest quality.
The size of our organisation means you'll have the opportunity to learn and work in different functions within R&D, giving you exposure to different disciplines, teams and environments. You will also have access to our Research and Development Academy, designed to develop our team and allow you to grow in our great organisation.
About the role
This pivotal Regulatory Manager role offers you the opportunity to champion collaboration across teams, enhancing your leadership abilities. As the bridge between Reckitt and regulatory agencies, your expertise will be key in guiding our innovative products through complex regulatory landscapes to reach consumers safely and efficiently.
The position reports to Senior Director Regulatory & Medical Affairs AMET, Global QPPV & dotted line to the Country General Manager.
Your responsibilities
Regulatory and Safety Advice:
- Providing regulatory and product compliance expertise in the area of advertising, label claims and printed packaging and promotional materials for existing and new products
- Protecting key brand and product claims using regulatory expertise
- Providing technical support and advice to respond to consumer and legal inquiries, regulatory issues for our products marketed in Pakistan
- Providing advice to Legal, Supply, Marketing and Finance in contract development, relating to medical and regulatory affairs and product safety
Drug Safety Training:
- Conducting training of employees and contracted services on Pharmacovigilance requirements
- Ensuring that drug safety is a positive asset for the Company in marketing our products successfully, and training the Sales Force for corresponding alertness
- Attending Pharmacovigilance training to remain up to date on the latest requirements
- Interacting with representatives of relevant government agencies, as and when required
Regulatory Compliance Champion:
- Ensure the registration and regulatory compliance of Reckitt Benckiser’s marketed products with relevant national regulatory requirements to bring competitive advantage to our brands.
- Ensure a co-ordinated and comprehensive approach to the management of compliance within Pakistan business
Regulatory Affairs – All Products – Pakistan / Afghanistan - Documentation Management System:
- Ensuring the compilation of national dossiers for submissions to authorities
- Ensuring the preparation, maintenance and update of product registration / license and regulatory compliance files
- Ensuring the amendment of registration dossiers as necessary for country-specific regulatory requirements and overseeing the submission of registration / variation applications and negotiating with governmental authorities to obtain rapid approvals
- Compiling Compliance Dossiers for manufacturing of products for the local market
- Managing and maintaining regulatory documentation filing system
- Co-ordinating for Certificates of Free Sales for export
- Developing national texts (e.g., PIL, SPC, packaging) including coordination of translations
Regulatory Requirements:
- Developing and maintaining a database of local regulatory requirements
- Monitoring and interpreting local regulatory issues and trends that will impact the marketability of company products, ensuring that the company is aware of significant local regulatory issues, and proactively leading the development and implementation of strategies to ensure regulatory compliance efforts that result in competitive advantage
Drug Safety Management:
- Collecting, assessing and reporting of all adverse events and adverse drug reactions to Global Medical Affairs (Drug Safety) Group
- Monitoring medical and regulatory publications and intelligence reports for changes in international regulations governing safety reporting, class labelling for relevant products, etc.
- Coordinating measures to address potential and identified drug safety risks
- Carefully evaluating reports from Global Medical Affairs concerning products that are of relevance to Pakistan, and taking corresponding actions, where necessary
- Collecting all adverse events and adverse drug reactions within Pakistan
- Fulfilling reporting requirements and timelines to authorities along with any submissions as per the requirements
The experience we're looking for
- At least 9 years’ experience in the in the OTC market and within a FMCG / pharmaceutical environment, with experience in Regulatory and / or Safety sales / trade marketing / marketing roles
- Must have approbation as pharmacist or degree in pharmaceutics, chemistry, human biology, human medicine, veterinary medicine, biochemistry or biology
- Broad knowledge of Pakistan regulatory and healthcare systems
The skills for success
What we offer
Equality
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Counseling, Pharmacovigilance, Nutrition, Healthcare