Company Description

At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit https://global.allerganaesthetics.com/. Follow Allergan Aesthetics on LinkedIn.
Allergan Aesthetics | An AbbVie Company

Job Description

The primary function of the Head of Regulatory Affairs, Allegan Aesthetics in China is to act as the representative of the regulatory affairs organization to the local commercial organization. The incumbent will ensure compliance with the company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives of AbbVie. The incumbent will have in-depth knowledge of the regulatory requirements in China. This expertise will also include but not be limited to the monitoring and influencing changes in regulatory policy and intelligence in China. The incumbent will oversee and manage the RA organization in China, including identification of resource needs and tasks in line with business priorities.

• Accountable for day-to-day management of the regulatory team in China, including effectively assigns team members responsibilities, plans and prioritizes resources.
• Manage competing priorities in partnership with the General Manager and local cross-functional teams in China, and in consultation with RA leadership teams.
• Develop and manage the China RA personnel through coaching, feedback, performance reviews and development plan discussions.
• Responsible for performance management of the China RA personnel, and for developing team members into more senior leaders within the organization.
• Assess the training and development needs of the China RA personnel, and ensure execution of the development plans taking both technical expertise and leadership capabilities into consideration.
• Effectively engage and interface with the local health authorities.
• Identify, plan and engage with industry associations relevant to the Allergan Aesthetics business.
• Provide leadership and guidance to RA personnel in China in assessing scientific data provided by specialist units for registration purposes against China regulatory/clinical requirements, identifying gaps and developing mitigation strategies to address gaps to ensure success registration of new products (including clinical trial applications). Ensure effective presentation of data, complete and timely responses to health authorities.
• Oversee RA members and ensure they represent China regulatory requirements and interests to Area Regulatory Product Team (ARPT) effectively to ensure those are met.
• Ensure regulatory compliance within China. Review and implement remediation plan to address identified gaps, if any.
• Primary RA interface with China Commercial and cross-functional teams. Provide strategic input for registration, ensure the business needs are met by anticipating and mitigating regulatory risks while ensuring compliance with regulations, assess probability of success for submission, approval and launch in China.
• Primary RA interface with other R&D functions, and provide strategic input from a regulatory perspective on matters such as but not limited to clinical development, inspection, safety etc.
• Maintain an active awareness of the legislative environment in China, assess the impact of any updates on AbbVie business and communicate effectively across the organization including but not limited to Area Regulatory Team, Regulatory Policy and Intelligence group.
• Support Long Range Planning and Future Fit initiatives in China. Provide regulatory counsel on selected business development activities as required.
• Oversees the regulatory affairs budgets for China including effective management of employee related resources. Monitor adherence to the budget throughout the financial year.
• Lead implementation and maintenance of processes and systems as appropriate. Review implementation of global processes and suggest improvements to current processes or develop new processes as required.
• Develop and maintain databases of regulatory knowledge as appropriate to drive efficiency and consistency. This includes but not limited to individual country data requirements, time to approval in China, fees payable to all types of regulatory submissions.
• Comply with Company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives of AbbVie.

Qualifications

• Bachelor’s degree in pharmacy, pharmacology, biology or related subject
• Minimum of 10 years’ pharmaceutical industry experience in R&D, with at least 8 years’ experience in Regulatory Affairs
• Experience in new drug or medical device applications including NCE or indication extension, clinical drug development and clinical trial applications
• People management experience
• Experience working effectively across cultures and in complex matrixed environment
• Strong leadership presence and solution-drive leadership style
• Excellent verbal and written communications at all levels
• Proficiency in communicating strategic and tactical issues to management
• Understands business needs and impact of regulatory issues on these
• Strong interpersonal, managerial, and organizational skills
• Experience in managing budget with finance acumen
• Ability to work independently

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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