Regulatory Affairs - Pharmacist

52% of the world can’t access essential healthcare: we’re a business that does something about it. Join us.

We focus on access to health products and services in underserved communities through a three-part model. We’ve built an app that works offline, operating in rural areas to equip community health workers to form a network of field agents. They collect data on health needs, which is used to design and implement targeted awareness and screening campaigns and enable supply of affordable medicines and products to rural pharmacies and stores, and we are now looking for someone to help grow the range of products and partners that we will help commercialize and distribute in low- and middle-income settings.

Why work with us? We are challenging established business norms, with a new value proposition to build a socially minded business model for half the planet. You get to be creative, move fast, own truly important things, grow, learn, and help people. We’re not a charity, we are redesigning how affordable healthcare is delivered through truly innovative business and service delivery models.

We already work with over half of the world’s largest pharmaceutical companies and have footholds in markets such as India, Indonesia, Philippines, Kenya and South Africa. We will be expanding rapidly over the next year and entering a number of new markets, particularly in Africa.

We’re just getting started though, so get onboard: do something that matters.

Who are we looking for?

Title: Regulatory Affairs Pharmacist

Start Date:  October, 2024

Location: Mumbai

Reporting to:  Africa regulatory director

reach52 is seeking a Regulatory Affairs Pharmacist, that will support reach52’s mission to build access to healthcare for 52% of the world, who currently cannot access it.  You will be responsible for compiling new dossiers for registration, managing variations and renewals, creating Summary of Product Characteristics (SmPCs) and Patient Information Leaflets (PILs) and checking artwork to ensure compliance with regulatory standards.

The core role scope and responsibilities of the role will be:

Dossier Compilation:

Compile and prepare regulatory dossiers for the registration of new generic medicines.

Ensure dossiers are in compliance with regulatory requirements and guidelines.

Liaise with cross-functional teams to gather necessary documentation and data.

Variation and Renewal Management:

Manage and submit variations to existing product licenses, ensuring all changes are documented and compliant with regulatory standards.

Handle the renewal process for product licenses, ensuring timely submission and approval.

Creation of SmPCs and PILs:

Develop and update Summary of Product Characteristics (SmPCs) and Patient Information Leaflets (PILs) for generic medicines.

Ensure all product information is accurate, clear, and compliant with regulatory guidelines.

Artwork Review:

Review and approve product artwork and labelling to ensure compliance with regulatory requirements.

Coordinate with the design team to make necessary adjustments and improvements.

Regulatory Compliance:

Stay updated on current regulatory requirements and guidelines.

Provide regulatory guidance and support to other departments within the organization.

Ensure all regulatory activities comply with relevant laws, regulations, and company policies.

Documentation and Record Keeping:

Maintain accurate and organized records of all regulatory submissions and communications.

Prepare and submit reports as required by regulatory authorities and internal management.

Liaison and Communication:

Act as a liaison between the company and regulatory authorities, ensuring effective communication and timely responses to inquiries.

Collaborate with internal teams to ensure alignment on regulatory strategies and submissions.

Who you are (probably!)

• Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field.
• Minimum of 2 years of regulatory affairs experience in the pharmaceutical industry.
• Experience with the CTD compilation.
• Knowledge of African regulatory environments.
• Understanding of international regulatory guidelines (e.g., ICH, WHO, CTD).
• Excellent attention to detail and organizational skills.
• Ability to manage multiple projects and deadlines simultaneously.
• Strong written and verbal communication skills.
• Proficiency in using regulatory submission software and tools.
• Embodies reach52 values.

Keywords

Regulatory AffairsPharmacistHealthcarePharmaceuticalRegulatory ComplianceDocumentationCommunicationCTD CompilationAfrican Regulatory EnvironmentsInternational Guidelines