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Regulatory Affairs Director, APAC (Therapeutic Areas)
The Regional Regulatory Affairs Director, Therapeutic Areas, plays an integral role for developing and aligning APAC regions regulatory strategy of specific projects assigned in the Therapeutic Areas of Ophthalmology & Women Health and RD pipeline and incorporates this into the global regulatory strategy project plan. The position leads the planning and implementation of APAC\xe2\x80\x99s regional regulatory strategy to guide and steer global product development teams to achieve earliest possible submission, first cycle approvals with best possible target labels for assigned portfolio aligned with APAC business strategy. This includes the assessment and reconciliation of all probabilities/possibilities of regulatory success as well as identification of risks and mitigation actions for the assigned portfolio covering RD pipeline and lifecycle projects, including early pipeline projects in Oncology.
YOUR ROLE AND RESPONSIBILITIES:

• Responsible for providing regional specific regulatory advice to Global Regulatory Strategists, scientific and technical leadership to regional brand teams and country RA in the development and deployment of APAC regulatory strategy for the assigned Therapeutic Area and pipeline projects throughout an assets entire product life cycle from Phase 1 onwards through product R&D, product approval, lifecycle management (incl. CMC and CCDS) and launch roadmap of pipeline assets.
• Acts as integral bridge between the global regulatory teams, local regulatory teams and global development teams to incorporate APAC regional requirements into RD programs enabling future go-to-market strategy at key drug development decision points and assesses options and likelihood of regulatory success in APAC region.
• Responsible for leading the creation and review of APAC submission plans aligned with APAC business strategy and Therapeutic Area objectives capturing submission requirements of health authorities and regulatory guidelines in the APAC region to achieve \xe2\x80\x98first-cycle approval\xe2\x80\x99. Works closely with MACS to shape APAC product labels and communicate this to Global Regulatory Teams.
• Guides global/regional/country participants in planning and preparing for health authority interactions and regulatory agency meetings.
• Guides regional regulatory due diligence for potential candidates for in-licensing and divestures.
• Leads regional regulatory teams and coordinate regional regulatory input into the global regulatory plans and global development plans.
• Monitors changes in regulatory environment in APAC, including competitor intelligence gathering. Communicates latest developments in regulations timely and advises global Regulatory Affairs organization and regional brand teams the relevance on assigned portfolio. Assesses impact and develops risk minimization proposal.
• Has oversight of roll out of regulatory compliance activities for assigned portfolio / APAC region according to local regulatory requirements, and to internal standards and KPIs. Provide guidance into internal process and standards development as needed.
• Represents Bayer and participate in industry association\xe2\x80\x99s forums to establish networks and look for opportunities to shape regulatory framework in alignment with the company\xe2\x80\x99s policy direction and business objectives.

WHO YOU ARE:

• Degree in Life Sciences or other scientific discipline with minimum of 12 years of pharmaceutical industry experience, including at least 5-7 years in regional/global regulatory roles. Proven track record in managing complex regulatory submissions to successful outcomes across various types of applications (e.g. Clinical Trials, New Drug Application, New Indication, major CMC) and across diverse portfolio (e.g. medical devices, therapeutic areas). Expert knowledge of regulatory process and regulations in South Korea, Taiwan, India, Australia, ASEAN. Advanced knowledge of regulatory process and regulations in US and EU.
• Must have advanced knowledge about clinical study methodology, pharmacovigilance, and clinical auditing procedures. Clinical data interpretation and statistical methodology knowledge is a plus.
• Demonstrated leadership and project management skills to handle complexity and ambiguity in a dynamic fast-paced environment, including stakeholder influencing and stakeholder engagement, cross-functional collaboration, effective communication.
• Must have strong analytical and critical thinking to evaluate complex ambiguous situations, identify potential issues and future trends. Demonstrated problem solving skills applied to regulatory topics such as application rejection, issue management, supply disruption and guiding country RA in health authorities\xe2\x80\x99 interaction.
• Fluent in English (verbal and written) with ability to communicate effectively, present and discuss (complex) technical information to regional stakeholders / global area experts confidently.
• Ability to remotely interact and lead highly diverse cross-cultural teams.
• Strong business acumen to partner effectively with regional and country management organizations.

YOUR APPLICATION





Local regulations and legal requirements vary per country of hire and will be discussed with considered candidates individually based on their potential of hire.





Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.




Bayer is committed to providing barrier-free access and support-facilities for individuals with disabilities - during the application process and beyond. Applicants with disabilities are encouraged to request any support / equipment they may need via the contact information below.




IMPORTANT NOTE for POTENTIAL CANADIAN CANDIDATES: This position requires full vaccination against COVID-19.




Location:
Singapore : Singapore : Singapore



Division:
Pharmaceuticals



Reference Code:
790059