Regulatory Affairs Manager

il y a 2 semaines


Alger, Alger, Algérie Cipla Temps plein

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

Support 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.


Accountabilities

Provides 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 activities

  • Provides 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 relationships

  • Build 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, etc
  • 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.
  • 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 registrations
  • Engages and interacts with IPD/ 3rd parties to explore synergies and opportunities for collaboration

Cross Functional Integration support

  • Ensures the team aligns with a matrix management approach
  • Communicates company vision and service culture
  • Provides 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 outputs

Supports and enables delivery for the Regulatory Affairs Department

  • Supports 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 team
  • Builds trust among team members by setting a highly visible example in terms of professional excellence and commitment to demonstrating Cipla values and competencies
  • Leads and supports the establishment of a team culture that values, recognizes and generates high performance, supports innovation and challenges the status quo
  • Participates in processes to share information and leverage initiatives across the department where appropriate
  • Supports 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 MOH

  • Engage 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 Experience

  • Pharm or higher (post graduate) scientific degree; Member of the pharmacists' professional body inAlgeria
  • Minimum 8-10 years experience and a minimum of 5-7 years experience in people management
  • Own regulatory intelligence, gap closures, and compliance

Required 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 registrations
  • Experience with registering generics, complex dosage forms, biologics etc. for drug registration in Algeria
  • Proven 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 thinking
  • Makes 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 working
  • Data driven recommendations on workload prioritization to teams on key focus areas to improve efficiencies and effectiveness in respective area of responsibility
  • Provide decisions and recommendations on Performance management and ratings
  • Provide key decisions on career discussions, training and development for the team and direct reports
  • Provide 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 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


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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