Johnson & Johnson Careers
Manager, Regulatory Affairs (Consumer)
Requisition ID: 1805698211W
Overall Purpose of the Job:
Ensure the organization complies with the statutory Regulatory, medical and drug safety requirements required by internal Johnson and Johnson policies/procedures and external government legislation/guidelines for Johnson and Johnson Consumer Company products.
Duties and Responsibilities:
- Ensure regional regulatory compliance is maintained for the full product range across all Philippines. Establish standard operational procedures to achieve efficiency within the Regulatory Affairs department, including interfacing with other departments to coordinate the development of regulatory procedures and controls to ensure product compliance in a timely manner.
- Lead and maximize operational performance and functional support for Philippines Regulatory Affairs function. Work with regional colleagues to identify core processes and support required to ensure projects can be aggressively implemented in Philippines with greatest commercial impact. Track, monitor and report on progress of regulatory applications.
- Manage internal regulatory resource, combined with external contract resource to best meet regulatory and business demands. Build a strong competent team to support each market.
- Proactively review, assess, influence and manage implementation of legislative changes within Philippines.
- Develop streamlined approaches across the countries in the Philippines sub-region including identifying where possible shared labeling or labeling components that exist across the sub- region/region.
- Establish and build on relationships with key contacts within the company and Regulatory Agencies. Act as an Ambassador for the R&D Department when required.
- Develop and maintain relationships, as warranted, with local Regulatory Agency and other external bodies. Use these contacts in lobbying or liaison activities,
- Manage expenses with budget and act on variances. Plan the allocation of funds and resources in line with R&D and business strategies.
- Work with regional colleagues to create, gain approval for and track the regional regulatory and medical budget.
Self and Staff Development
- Ensure development plans and training programmes are devised and maintained on an ongoing basis.
- Ensure personnel and contractors are adequately trained on company processes and policy.
- Ensure Performance Evaluations are carried out in line with Corporate guidelines.
Leadership and Management
- As appropriate and authorized, recruit and retain suitably qualified regulatory/medical personnel and assign responsibilities accordingly. Lead an effective team, and establish a strong talent development plan and succession pipeline
- Provide strategic direction and advice to local and regional business partners.
- Ensure systems are in place to ensure compliance with National Regulatory Authority and Corporate requirements.
- Represent the interests of R&D by participating with the Philippines Business Management/Retail Board and ASEAN Leadership teams. Take part in strategic decisions affecting the local business.
- Attend and contribute actively in Commercial Planning/appropriate R&D meetings.
- Adhere to relevant procedures and practices to ensure that Good Clinical/Regulatory Practice (GCL/GPR) is maintained within the department, as appropriate. Make recommendations where necessary.
- Instill in colleagues business ethics and compliance with company policies, laws, regulations related to their jobs and ensures their compliance.
- Registered pharmacist with Philippines (preferred)
- Appropriate Clinical/Regulatory Affairs experience – Minimum of 7 years spent within a pharmaceutical or consumer health or personal care company, within Philippines, including the preparation of Registration Files and contacts with Health Authorities and other official organization/professional entities related with this job.
- An extensive knowledge of pharmaceutical and/or cosmetic technology;
- Strong organizational and interpersonal skills;
- Management and inclusive leadership skills;
- Strategic thinking for effective influencing;
- Full command of English and native Philippines language;
- Fluency in some other Asian languages would be an advantage
Johnson & Johnson International (Singapore) Pte. Ltd. - ROHQ