Regulatory Affairs Manager
il y a 2 jours
Job Title
Regulatory Affairs Manager
Reports to
Regulatory Affairs Executive / Director
Location
Algeria, Algiers
Division
Integrated Product Development (
Employment Type
Permanent
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.
Job Purpose
To manage the therapeutic portfolios assigned to Algeria, in every aspect of new product submissions, product registration and life-cycle management including artwork control by ensuring high quality, timeous submissions, responses and approvals. To conduct and complete technical and administrative duties on dossiers.
Accountabilities
Regulatory intelligence
· Provide regulatory intelligence pertaining to the current regulatory landscape and potential impacts for the team and wider business
· Stay up-to-date on the different local, regional and global regulatory issues and specific regulatory requirements for Algeria and North Africa.
Prelaunch stage product submission and registration activities
· Ensure pre-launch stage product submission and registration activities including establishing regulatory strategies for submission,
· First-to-market focus: Prioritize early engagement with ANPP to secure competitive registration timelines.
· Operational excellence: Complete quality checks on dossier, monitor dossier payments and conduct regular follow-ups with ANPP.
Dossier life cycle management activities
· Compliance assurance: Stay aligned with the latest regulatory guidelines.
· Document integrity: Ensure all documents meet regulatory standards through thorough quality checks
· Labeling & packaging: Oversee the review and approval of product artwork to ensure full compliance with local regulations
Support and enable delivery for the Cipla India regional regulatory team
· Build trust among team members by setting a highly visible example in terms of professional excellence and commitment and participating in team culture.
· Promote transparency and shared accountability across functions
· Participate in processes to share information and leverage initiatives across the region where appropriate.
· Support and encourage knowledge sharing between/across Cipla Regulatory and Regional North Africa teams
Develop and manage stakeholder relationships
· Build and pro-actively maintain critical relationships with the Health Authority and equivalent bodies in other countries to ensure streamlined submissions, evaluations and quicker registrations.
· Engage with relevant officials and evaluators at ANPP and MOPI to ensure quicker approvals for Cipla applications.
· Engage and interact with suppliers to explore synergies and opportunities for collaboration.
Ensure execution of all regulatory activities
· Represent Cipla for annual import program,
· Prepare and monitor request of import permits required for sample, reagent and materials
· Ensure submissions of regulatory applications within targeted timelines
· Ensure regular and on-time payments of any retention and renewal fees due.
· Carry out Pharmacovigilance
· Maintain records of the applications submitted to authorities and keep track of approvals
· Notify relevant stake holders about the outcome of applications
Cross functional integration support
· Ensure alignment with a matrix management approach.
· Communicate company vision and service culture.
· Provide input and feedback around how the function can service the business optimally.
Engagement with Exploitant and MOH
· Engage with respective Exploitant in Algeria to ensure on-time submissions and registrations.
Qualification and Relevant Experience
· Pharm or higher (post graduate) scientific degree; Member of the pharmacists' professional body in Algeria
· Own regulatory intelligence, gap closures, and compliance
Required Skills:
• Proven skills in Business acumen, People Management experience, Negotiation and influencing skills and a collaborative approach.
• Analytical mindset with attention to detail and strategic thinking
• High integrity and commitment to quality and ethical standards
• Good French and English communication skills
• Vehicle is mandatory for field work
Employee Benefits & Perks
From 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 it
Hybrid Work Model
Individual centered upskilling
Mentorship & Coaching Pathways
Wellness First: Mental health, physio, mindfulness & more
Full-Day Birthday Leave
Recognition & Great Place to Work Vibes
Green Office Spaces Built for Well-being
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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