Assoc. Dir., Regulatory Affairs
Assoc. Dir., Regulatory Affairs
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Job Description
Job Description
POSITION OVERVIEW:
The Associate Director of the Regulatory Affairs (RA) is responsible for the overall management of regulatory affairs activities including pharmacovigilance work at RA department at PDRA division Animal Health in Japan. The position requires a combination of scientific knowledge understanding of regulatory requirements strategic thinking and team leadership to ensure timely development of new products and regulatory affairs activities.
The individual will ensure that the RA team develops and successfully executes project plans for timely product registrations.
The individual will motivate and encourage the RA Team to perform successfully and will mentor and coach team members to oversee their personal development in the organization.
The individual will closely communicate with members at the Product Development department to optimize the regulatory submission and get products approved.
Reporting lines:
- The RA Associate Director reports directly to the PDRA director
- The RA Associate Director manages a team of 5-7 colleagues of RA department.
PRIMARY ACTIVITIES:
- Support PDRA director to optimize/maximize PDRAs activities by following ways:
- Build PDRA as one team to have a seamless communication/collaboration
- Review/advice Gap analysis done at PD department and create PDRAs one
- Set up agreed product profiles among PD and RA.
- Harmonize local requirements into the global development plan based on the well-prepared development plan.
- Liaise with Sales BU in the identification of market potential/requirements for new vaccines vaccine improvements and pharmaceutical products
- Oversee the scientific quality of work within the unit to maintain and enhance reputation for excellence
- Lead the RA team to ensure timely development of biological and pharmaceutical veterinary products in Japan in compliance with the general pharmaceutical guidelines and with local laws.
- Ensure that the RA team develops optimized development plan by leveraging global data.
- Oversee the collaborations with Contract Research Organizations (CROs). Ensure contract management and quality oversight of CROs.
- Ensure compliance of organizational structures internal processes operational activities & reporting including national and overseas pharmacovigilance requirements in line with the respective pharmaceutical law guidelines
- Provide advice on research issues problems and trends having significant impact on RA activities of short and long-term goals
- Optimize the performance of RA colleagues by coaching motivating training and evaluating them properly in line with global and local development program including setting and reviewing individual yearly objectives and development plans
BACKGROUND REQUIREMENTS
Following leadership behaviors are expected
- Be Purposeful Capturing the meaning of our work following our mission to improve peoples lives and adhere to ethical behaviors.
- Be empowering Unfolding potential in self and others by providing guidance driving personal development and sharing enthusiasm.
- Be collaborative Working together across departments encouraging teamwork that respects diverse backgrounds and culture differences.
- Be Results-driven Setting ourselves stretch performance target as well as establishing as establishing a feedback culture and taking responsibility.
- Be innovative Constantly experimenting and driving change initiatives. This includes being open to new ideas. Making quick decisions and taking risks.
- Be future-oriented Continuously seeking best practice solutions and embracing opportunities of new technologies to shape the future of our business.
Education
- Veterinarian or PhD in Biological or Animal Sciences preferable.
Experience
- Minimum 7 years of relevant experience in a regulated industry preferably healthcare most preferably in the field of veterinary vaccines or pharmaceuticals.
- Knowledge of Japanese Regulatory System preferable
- Experience leading teams and developing/coaching people to maximize people/team capability.
- Working in a matrix environment with multiple stakeholders at local and global levels.
- Experience in planning and drafting budgets.
Skills Knowledge and Competencies
- Language Japanese (fluent) English (professional level verbal and writing)
- Highly developed skills in negotiating influencing leadership and staff motivation.
- Excellent communication and organizational skills.
- Ability to work well with other departments in a multicultural team setting and matrix organization
- Familiarity with animal diseases and animal husbandry techniques and ability to understand our product users including farmers and veterinarians.
- Knowledge of Microsoft Office
Current Employees apply HERE
Current Contingent Workers apply HERE
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Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.
Employee Status:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Required Skills:
Adaptability Adaptability Animal Husbandry Change Management Communication Cross-Cultural Awareness Cross-Team Coordination Data Management Employee Training Programs FDA Regulations Maintenance Processes Management Process Microsoft Office Pharmacovigilance Policy Implementation Product Development Product Registrations Regulatory Affairs Compliance Regulatory Affairs Management Regulatory Compliance Regulatory Labeling Regulatory Management Regulatory Operations Regulatory Submissions Software Office 2 morePreferred Skills:
Job Posting End Date:
06/30/2026*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Employment Type
Full-Time
