Cipla

Regulatory Affairs Manager

Posted: 1 days ago

Job Description

Job TitleRegulatory Affairs ManageršŸ” Reports toRegulatory Affairs Executive / Director🌐 LocationAlgeria, Algiers🧭 DivisionIntegrated Product Development (šŸ“ Employment TypePermanent🧬 Why Cipla?At Cipla, Caring for Life isn’t just our purpose-it’s our promise. We’re here to Make Life Thrive by making quality healthcare more accessible, inclusive, and impactful across the continent. With innovation at our core and compassion in every decision, we’re building teams that challenge conventions, uplift communities, and shape the future of healthcare. Whether you’re in labs, logistics, leadership, or out in the field - every role fuels our mission. At Cipla, you grow with purpose, lead with empathy, and belong from day one. šŸŽÆ Job PurposeSupport the SAGA RA Director by leading and managing the Algeria region in every aspect of new product submissions, registrations, variations, and other dossier life cycle management activities, by ensuring high quality, timeous submissions and approvals.šŸ“Œ AccountabilitiesProvides regulatory Intelligence to Cipla RA Managers/Executives/ RA Director and CEO to aid decision making. Provide insight into business impact and recommend strategies to adapt.Assists the Regulatory Affairs Department Managers/Executives and Director by providing:Regulatory intelligence pertaining to the current regulatory landscape and potential impact for the team and wider business related to new registration pipeline and variation submission and registration/ approvals for Algeria with extended scope for North Africa.Up to date information on the different local and worldwide regulatory issues and specific regulatory requirements for different geographies where Cipla is involved.New dossier submissions, registrations, and life cycle management activitiesProvides direction and guidance to the Regulatory Affairs Managers/Pharmacists or team for specific pre- and post-registration activities and ensures that assigned workload and activity timelines are effectively set, managed and communicated. Aligns and influences key stakeholders involved in the new dossier submissions, variations, and approval processes, to ensure required support is provided by the stakeholders, thereby ensuring the desired outcomes for the department are attained.Ensures that all assigned dossiers and variations as received from Integrated Product Development team (IPD) and third parties are submitted timeously to relevant Health Authorities (HA) and are followed up on regularly to ensure first-to-market registrations/ approvals.Ensures that the Regulatory Affairs teams follow the standards, protocols and processes around obtaining dossiers and gathering supporting data from suppliers following signing of supply/purchase / financial agreements Develops and manages stakeholder relationshipsBuild trust among team members by setting a highly visible example in terms of professional excellence and commitment and participating in team culture.Identifies and develops key relationships within the Cipla North Africa Regulatory team (Algeria/ India), QA, Portfolio, Medical, Project Management, Commercial, BD, etcAligns and influences key stakeholders involved in the new dossier submissions, variations, and approval processes, to ensure required support is provided by the stakeholders, thereby ensuring the desired outcomes for the department are attained.Builds and pro-actively maintains critical relationships with the Exploitants, Health Authority (ANPP, MOPI) and equivalent bodies in other countries to ensure streamlined submissions, evaluations and registrationsEngages and interacts with IPD/ 3rd parties to explore synergies and opportunities for collaborationCross Functional Integration supportEnsures the team aligns with a matrix management approach Communicates company vision and service cultureProvides input and feedback around how the function can service the business optimally Engages, communicates and collaborates with various internal business units, to drive alignment and manage outputsSupports and enables delivery for the Regulatory Affairs DepartmentSupports the Regulatory Affairs Director and Regulatory Affairs Department Management team to ensure that Cipla values and leadership standards are communicated and understood at all levels within the teamBuilds trust among team members by setting a highly visible example in terms of professional excellence and commitment to demonstrating Cipla values and competenciesLeads and supports the establishment of a team culture that values, recognizes and generates high performance, supports innovation and challenges the status quoParticipates in processes to share information and leverage initiatives across the department where appropriateSupports and encourages knowledge sharing between and/or across the full SAGA Regulatory team (SA, SSA, CGA, North Africa), QA, Portfolio, Medical, Project Management, Commercial, BD, IT Engagement with Exploitant and MOHEngage with respective Exploitant in Algeria to ensure on-time submissions and registrations.Constant communication/follow-ups (email, phone, f-2-f visits) on the key priority products for Cipla so that outcomes are obtained in the shortest possible time. Face-2-face engagement wherever possible. Networking during industry meetings/workshops. Develop a process of HA Engagement that can be measured and tracked vs outcomes and results🧾 Qualification and Relevant ExperiencePharm or higher (post graduate) scientific degree; Member of the pharmacists’ professional body inAlgeriaMinimum 8-10 years experience and a minimum of 5-7 years experience in people management Own regulatory intelligence, gap closures, and complianceRequired Skills: Builds and pro-actively maintains critical relationships with the Exploitants, Health Authority (ANPP, MOPI) and equivalent bodies in Algeria to ensure streamlined submissions, evaluations and registrationsExperience with registering generics, complex dosage forms, biologics etc. for drug registration in AlgeriaProven skills in Business acumen, People Management experience, Negotiation and influencing skills and a collaborative approach.Represent Cipla for the Import Program in Algeria Analytical mindset with attention to detail and strategic thinkingMakes recommendations to One Africa RA Head for new dossier or variation submissions strategy on opportunities to create greater efficiency within the department and improve processes and general ways of workingData driven recommendations on workload prioritization to teams on key focus areas to improve efficiencies and effectiveness in respective area of responsibilityProvide decisions and recommendations on Performance management and ratingsProvide key decisions on career discussions, training and development for the team and direct reportsProvide decisions on stakeholder engagement and influence (internal and external) – who, what, when and how to communicate to key stakeholders and obtain buy-in.High integrity and commitment to quality and ethical standardsGood French and English communication skillsVehicle is mandatory for field workšŸŽ Employee Benefits & PerksFrom wellness days and hybrid work to Cipla University and real mentorship, we don’t just care for life, we power up your growth while we’re at itšŸŒ Hybrid Work Model 🧠 Individual centered upskilling 🧭 Mentorship & Coaching Pathways 🧘 Wellness First: Mental health, physio, mindfulness & more šŸŽ‚ Full-Day Birthday Leave šŸ… Recognition & Great Place to Work Vibes šŸš€ Ready to Apply? Hit Apply Now or connect with our Talent Acquisition Team. At Cipla, we don’t just hire talent, we invest in voices that move us forward

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