Johnson & Johnson Careers
Head of Regulatory Affairs
Requisition ID: 1905763627W
Johnson & Johnson Services, Inc. is recruiting for a Head of Regulatory Affairs to be located in Istanbul.
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for more than 130 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
With $81.6 billion in 2018 sales, Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. There are more than 260 Johnson & Johnson operating companies employing approximately 135.000 people and with products touching the lives of over a billion people every day, throughout the world.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer. And our culture is interconnected by the shared values of Our Credo. It’s a culture that celebrates diversity and diverse perspectives. It helps employees achieve an effective mix between work and home life and supports their efforts to have a positive impact on their communities.
A. REGULATORY AFFAIRS ACTIVITIES
- To perform all required product tasks, following the plan and updates from EMEA, enabling optimal label implementation and maintenance and to make sure core CVT is up to date with all relevant RA product-related updates, enabling local strategy optimization
- Ensure an efficient cooperation with all Regulatory Affairs colleagues
- optimal internal and external communications and alignment with the EMEA regional Regulatory Affairs (GRA) organization
- Ensure that, where relevant local issues are identified as potentially impacting RA strategy, these are highlighted to IBVT RA, to ensure that the IBVT RA strategy can be implemented smoothly
- Ensuring optimal compliance to local, regional and Janssen regulations, to minimize risk for the patient and Janssen business
- Provide relevant regulatory intelligence to other company departments and its interpretation / impact to enable strategic decisions e.g. CVTs.
- Have a strong leading influence on main regulatory external stakeholders and regulations, in line with EMEA strategy, maximizing the possibilities of success for market access, reimbursement and lifecycle maintenance of Janssen products
B. OVERALL RESPONSIBILITIES
1. Management of the Regulatory Affairs Department;
- Ensure marketing authorizations and updates are in line with Regulatory Affairs requirements
- Prioritize Regulatory Affairs objectives and projects to best meet the needs of the Local Operating Company
- Ensure and promote strategic role and partnership of the Regulatory Affairs though the core role of TA Experts at the CVTs
- Align LOC Regulatory Affairs goals and objectives and ensure implementation of the EMEA/GRA strategic functional objectives
- Set-up budget and its priorities and follow-up on expenditures
2. Management of the external regulatory environment;
- Oversight and building and sustaining positive relationships with the local health authorities and represent company in regulatory trade association to lead and influence the regulatory environment changes and evolution
- Ensure a high level of regulatory professionalism, which allows high quality local interaction with HAs, at product- and non-product level
- Assess the impact of the legislation changes on the business and ensure organization readiness to address them proactively
3. Influence and shape the external environment applying a long-term strategy while focusing on and being aware of priorities and objectives (J&J, Janssen, GRPI, EMEA RA, LOC (RA) and sensitive issues), by:
- Being active in regulatory workgroups in local trade associations, making sure we are part of (sub)workgroups on specific topics that are relevant to the Janssen objectives.
- Building relationships with regulators and policy-makers, bringing the Janssen opinion to the discussion / negotiating where possible
4. Shares updates on the Regulatory environment locally and regionally
5. Providing background information to EMEA on KOLs involved in regulatory decision making (e.g. approval procedures, scientific advice meetings, etc
C. PEOPLE MANAGEMENT
- 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 act as a coach to the members of the RA team
- Accountable for talent- and career development of team-members
- University Degree (preferably Pharmacy, Chemistry, Chemical Engineering)
- 8 or more years of experience in RA, at least 3 years experience in TA Expert or External lead role, including proven experience with people management.
- Big picture view of the regulatory role in the pharmaceutical industry
- Able to analyze (complex) information and situations and to formulate clear advises
- Very strong interpersonal and communication skills; able to influence without authority.
- Strong project management, problem solving and negotiating skills
- Able to make independent decision
- People management skills
- Apart from a language, very good knowledge of English, verbal and written
- Multitasking, accurate and conscientious
- Knowledge of regulatory IT systems (document management, planning, databases…)
Johnson & Johnson Sihhi Malzeme Ltd. (7347)