Johnson & Johnson Carrières
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Head of Regulatory Affairs M/F - Maghreb and French Speaking Africa
Description du poste
Requisition ID: 1805634062W
Are you keen to join a multinational pharmaceutical company and lead the regulatory strategy for key development and marketed compounds in Maghreb and French Speaking African (FSA) sub‐Saharan FSA Countries?
Your regulatory expertise will be the key to opening up further opportunities for patients to access our rapidly expanding portfolio of ground breaking small and large molecules.
You will have the responsibility for developing and implementing an innovative and robust regulatory strategy for Janssen products to drive optimal market access for patients.
- Develop and lead the Regulatory strategy, Operational and Compliance activities in Maghreb, and FSA countries (including Global Public Health countries) to meet local requirements and company objectives
- Ensure an efficient cooperation with all Regulatory Affairs colleagues
- Contribute to Commercial Leadership Team Meetings as required
- Ensure appropriate Regulatory representation in cross‐functional strategic team by leveraging off Regulatory Affairs (RA) Expert for the corresponding Therapeutic Area.
- Represent Janssen as External Lead for Maghreb and FSA Countries, as appropriate
- Ensure Regulatory Affairs Experts are appropriately equipped to provide relevant regulatory intelligence to other stakeholders, e.g. country/cluster value teams, Emerging Markets Regulatory Liaisons, Regional Strategy Implementation team
- Mobilise appropriate regulatory support for tenders and daily business and product supply in accordance with J&J guidelines, local laws & regulations
- Ensure optimal internal and external communications and alignment with the EM Regulatory Affairs Head
- Contribution to the Global Regulatory Affairs (GRA) organization ‐ Support and ensure adequate contribution of the Regulatory Affairs team to GRA initiatives
- Lead the Regulatory Affairs Team in Maghreb & FSA
- Work with Commercial and cross‐functional teams to ensure Maghreb and French Speaking African market opportunities are understood and aligned with Global Regulatory strategies, to deliver ambitious Regulatory milestones.
- Ability to develop and lead the Regulatory strategies and activities in Maghreb & FSA countries to meet local requirements and company objectives whilst ensuring all labelling and CMC aspects are in keeping with product characteristic.
- Ensure Therapeutic Area aligned Regulatory Affairs Expert contribute to country/cluster value teams
- Contribute to shaping Regulatory policy by being the External Lead for Maghreb & FSA Countries
- Advocate a culture of strong compliance to internal and external regulatory requirements
- Provide regulatory assistance for tenders and support daily business from regulatory affairs perspective in accordance with Janssen guidelines and local laws & regulations
- Ensure direct reports receive appropriate training in the Regulatory Affairs environment and functional skills. Encourage appropriate training and development
- Set clear performance standards, provide feedback and coaching, and hold team members accountable for key deliverables
- Conduct annual performance reviews with direct reports to help support the creation of a diverse, high performing RA organization
- Provide leadership support to team members and coach members of the RA team where appropriate
- Take accountability for talent‐ and career development of team‐members
- Oversee and engage with Maghreb & FSA (including GPH countries in FSA /sub‐Saharan FSA) External Leads in building and sustaining positive relationships with the local health authorities and ensuring that External Leads represent the company in regulatory trade associations in order to lead and influence the regulatory environment changes and evolution
- Ensure a high level of regulatory professionalism, which allows high quality local interaction with health authorities, at product‐ and non‐product level
- Assess the impact of the legislation changes on the business and ensure organizational readiness to address them proactively. Communicate impact to Emerging Markets Regulatory Liaisons
- Work with Business Compliance to implement processes, standards and training that ensure a continuous high regulatory compliance level and a constant status of “audit & inspection readiness”.
- Ensure systems are in place to track Marketing Authorisation Holder obligations, queries in this region and maintain licenses valid for business continuity etc.
- Oversee regular archiving of health authority communications.
- Ensure Regulatory Management Centre staff manage variations to licenses according to internal timelines.
The above listed job duties and overall responsibilities are not exclusive or exhaustive and the post holder will be required to undertake such tasks as may reasonably be expected within the scope and grading of the post.
* Demonstrated experience of regulatory drug development, and regulatory approvals/product
launches within emerging markets of Maghreb and FSA or experience at a health authority
* Significant experience of regulatory filing of small and large molecules in Maghreb and FSA
- Big picture view of the regulatory role in the pharmaceutical industry
- Able to analyze (complex) information and situations and to formulate clear advice
- Very strong interpersonal and communication skills; able to influence at all levels
- Strong project management, problem solving and negotiating skills
- Able to make well informed decisions
- People management skills
- Multitasking, accurate and conscientious individual
- Knowledge of regulatory IT systems (document management, planning, databases etc.)
France-Haute-de-Seine-Issy Les Moulineaux
Janssen Cilag S.A.S. (7825)