Sign In
 [New User? Sign Up]
Mobile Version

Head of Regulatory Affairs


Thành Công, Hà Nội
Apply on the Company Site
  • Save Ad
  • Email Friend
  • Print
  • Research Salary

Job Details

**Position Purpose**

+ To lead, manage and provide strategic direction and oversight to the Country based regulatory teams to develop and execute regulatory strategies and plans for the country and region, where applicable.

+ To ensure collaborative connectivity with the key stakeholders (e.g. Commercial, Medical, etc) and a more focused regulatory approach to supporting country business objectives.

**Primary Responsibilities**

+ Lead and manage the local RA team in the development of regulatory strategies to support the registration of clinical trial applications, new products, line extensions, major variations and lifecycle management.

+ Develop strong partnerships with in-country (e.g. Country Managers, Medical, Marketing, Supply Chain) and Regional Teams to facilitate the development and implementation of registration strategies to expedite the registration of new products, line extensions and life-cycle optimization.

+ Provide strategic contribution to the country leadership team

+ Responsible for the development, leadership and performance management of the local RA team to achieve company objectives.

+ Responsible for developing and enhancing relationships with key external agencies (HA's/BoH, RKOL's, etc.). Manage the HA/BoH interface throughout the development and lifecycle of a product. Develop a long-term and positive relationship characterized by integrity, quality, compliance and leadership. Act in the capacity as the main liaison and primary contact for local government regulators with regards to all regulatory affairs related activities.

+ Active participation in local trade organization and effective communication to key stakeholders of key issues that could impact regulatory strategies or the business. Understand local regulations and developing trends in the local regulatory environment and provide assessment of the impact to key stakeholders. Leverage regulatory intelligence / landscape knowledge to support the development and implementation of regulatory and business strategies and decision making. Positively influence local legislative initiatives that could impact the business.

+ Maintain licenses (e.g. Marketing Authorizations) in compliance with local regulations by ensuring that corporate regulatory processes, SOP's and systems (e.g. CMC change control, product labelling, etc.) are in place, and that the local RA staff (permanent and contract) are properly trained in these systems and procedures.

+ Oversee and manage the completion of CTA, NDA and Lifecycle (LC) submissions and approvals as per established performance metrics.

+ Responsible for ensuring that all regulatory activities (new product submissions, clinical trial applications, existing licenses, etc.) are compliant with local regulations, requirements and practices.

**Technical Skill Requirements**

+ Knowledge of the Regional and Global regulatory environment and how this impacts regulatory strategy and implementation: Understanding of regulatory agency philosophies, culture, and developing trends in the regulatory environment. Working with and influencing, opinion leaders, external organizations and facilitating approval of submissions. Is driven to continually enhance regulatory expertise, both locally and globally.

+ Knowledge of drug development practice, rules, regulations and guidelines: Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines relevant to Regional regulatory strategies and implementation plans. Maintains internal and external networks to learn in advance about new regulatory trends or changes impacting the Regulatory, Medical and overall Business strategy.

+ Strategic Thinker: Provides strategic contribution and anticipates what RA needs to contribute to develop and achieve business objectives. Effectively explores alternative regulatory strategies and positions to reach outcomes that gain the support and acceptance of all parties.

+ Communication skills: Clearly conveys information and ideas through a variety of media to individuals or groups in a manner that engages the audience and helps them understand the message.

+ Negotiation skills: Can negotiate skillfully in tough situations with both internal and external groups. Can be direct and forceful as well as diplomatic. Gains trust quickly of other parties to the negotiations. Has built a strong relationship with the local health agency and other relevant stakeholders (KOL's) and pro-actively manages issues with the HA's and other key external stakeholders.

+ Problem Solving: Effectively identifies issues and challenges and works with partner groups to identify options and implement agreed upon solutions.

+ Understands Business and Financial Environment: Understands how role is impacted by and contributes to external business environment and financial drivers.

+ Understands Pharmaceutical Industry: Understands and develops mitigation strategies for issues and drivers impacting the Pharmaceutical industry. Understands the need for connectivity and active contribution to local trade industry groups, being a recognized regulatory professional partner, and the strategic importance of this information to the local business.


**Training & Education Preferred:**

+ Scientific Degree. MsC. PhD in Medicine.

+ Appropriate Regulatory Experience - 8 years experience

**Prior Experience Preferred:**

+ Demonstrable experience across the Drug, Discovery, Development and commercialization lifecycle, with proven examples of contribution.

+ Proven ability to manage complex regulatory issues.

+ Proven ability to consistently deliver to time, cost and quality standards.

+ Regional regulatory experience including knowledge of CTA's and NDA submission processes and product life cycle management activities.

+ General management experience and previous line management and leadership experience at senior management level is essential.

+ Demonstrable experience of effective delivery in a complex matrix environment

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Apply on the Company Site
Powered ByLogo

Featured Jobs[ View All ]

Featured Employers [ View All ]