Head of RA, Philippines

Kingfisher Recruitment (Singapore) Pte Ltd

-

Head of Regulatory Affairs (Pharmaceuticals), Philippines
Position purpose
  • Responsible and accountable for all regulatory affairs activities of Bayer Pharma (PH)
  • To provide effective functional leadership and governance into planning, development and execution of regulatory strategies and RA departmental activities, alignment of these with business plans and strategies through cross-functional collaboration enabling efficient implementation of growth, brand value and other programs; drive and lead regulatory expert input to all stakeholders in development of business plans and strategies and on issues management.
  • Scope of regulatory activities includes all maintenance and development product activities dealing with the relevant Health Authorities and government bodies in relation to pharmaceuticals (Rx-Non-Rx), listable products & medical devices marketing authorisation/permission / notification.
  • The position will have to consider and balance the business objectives and priorities of the divisional country heads.
  • Ensure the best regulatory planning and preparation for all new chemical/biological entities (NCE/NBEs), new indications and line extensions to be registered in the best possible timeframe and with the best possible label. Maintains full awareness of all regulatory activities for assigned geography and ensures project deadlines and performance standards for these projects are established and met.
  • Ensure that the overall regulatory functions and all PH products remain compliant with all relevant regulatory, corporate and legal policies, procedure and practices throughout their product life cycle. Develop and implement standards to enable compliant practices and processes.
  • To partner with relevant stakeholders within PH to assist in achieving optimal company outcomes, cross-functionally and not limited to cluster stakeholders only but also the AP region and global regulatory affairs.
  • Formulate and develop roadmap for Regulatory Affairs department in short term and long term vision. Provide leadership to RA to ensure goals are achieved in the most optimal and timeous way with solution oriented ‘can do’ approach.
  • Inspire, motivate the RA team towards functional excellence to meet current and future regulatory affairs objectives in alignment with commercial objectives effectively for assigned geography and be acknowledged as value-add business partners
  • Ensure maintenance of required licenses for proper functioning of the company, e.g. GMP certificate, manufacturing license (if applicable), special functioning licenses, and provision thereof on request
  • To ensure local regulatory processes and procedures reflect current best practice
  • Act as the regulatory expert and voice to country management organization for assigned geography
  • Prepare and manage RA Singapore/Malaysia/Brunei resources and corresponding budget within defined targets set

 
  1. Major tasks and responsibilities of position
  • Accountable for setting and leading local regulatory strategic and operational matters to fulfil the local business strategies, in collaboration with the local cross-functions and in consultation with Regional RA Heads and other Global regulatory units for functional alignment. Ensures transparent, timely and efficient communication with business, supply chain and other local functions, regional/global regulatory affairs, providing regulatory expertise to achieve common decisions.
  • Lead, develop organization to assure diligent and professional regulatory checks for assigned portfolio and timely delivery of documentations, compliance support to R&D and other stakeholders on development activities and issue management. Continuously identifies and implements efficiency, productivity goals for integrated RA organization (resources, processes, systems).
  • Identifies resource requirements and allocates resources to meet regulatory needs.
  • Ensures early identification of conflicts between projects and ensures transparent and aligned prioritisation.
  • Ensures the preparation of the application files for products based on the documentation provided from RA Regulatory Partners in accordance with local regulations, is of acceptable standard and quality for the respective authorities.
  • Where applicable, ensures the preparation of the application files for clinical trials, based on the documentation provided from RA Regulatory Partners, are in accordance with the local regulations and presents them to the respective authorities, where locally relevant.
  • Supports the LQR to plan, manage GMP inspection requirements incl. GMP applications, inspections and certifications of the manufacturing sites as locally relevant. Work closely with LQR to provide regulatory expert input to manage product complaints and recall process, including health authority interaction and communications.
  • Provide necessary functional input and documents to enable LQR to complete local compliance checks and develop local QSD process.
  • Regulatory quality management: Responsible for local and internal compliance to regulatory affairs relevant processes and systems, creation and maintenance of a local quality system including archiving, contact reporting, maintenance of regulatory tracking database and tracking of documents submitted.
  • Manages training and audits of the quality system
  • Ensures regulatory compliance for a sustainable life-cycle management: Labelling and CMC changes are performed in accordance with local regulations and relevant Bayer SOPs
  • Responsible to represent PH as a competent reliable partner to the local Health Authorities in all regulatory matters, to enable timely approvals with optimal labels. Establish, maintain and drive external contacts, networks, partnerships and both-ways communication with national regulators, local industry organisations, key opinion leaders and other external stakeholders to proactively shape the regulatory environment in the country.
  • Identify best options and opportunities for business and to pre-empt business issues. Ensures appropriate representation of Bayer in the local industry associations. Oversees communication with Health Authority to ensure Bayer one voice policy.
  • Provides local RA intelligence: Identifies current and emerging national regulations which impact the drug development and / or marketing processes and ensures appropriate contribution and communication with all involved areas. Contributes actively to design and assessment of RA strategic options as a member of regional regulatory teams.
  • Track regulatory updates that affect Bayer portfolio and translate regulations into opportunities for Bayer.
  • Partners with regional PH RA heads to ensure alignment with functional vision and direction:
  • o Following PH integration, establish an integrated RA team, setting common and aligned functional vision and purpose to deliver functional excellence and regulatory leadership to internal/external stakeholders
  • o To provide regulatory stewardship in role as Head of Regulatory Affairs PH providing leadership and functional excellence in addressing important regulatory issues, performing gap analysis and develop mitigation plan, timely inform country management and functional stakeholders of issues with impact on portfolio, fully leveraging the resources and functional expertise available through regional/global regulatory teams
  • o To timely communicate to regional team emerging issues, status and progress of key regulatory activities pertaining to submissions, approvals, safety & quality alerts, health authority interaction, supply constraints
  • o Creates and supports a learning environment for team members with development plans balancing country business and RA needs vs individual’s aspirations, continuously raising performance standards benchmarking against high-performing organizations.
  • o To promote cross-fertilisation between PH RA team with flexibility to work across diverse portfolio of products as needed
  • o To manage department’s budget and headcount within targets provided while continuously looking for ways to improve efficiency in processes, resource allocation
  1. Value added to the success of the company
  • Responsible and accountable for Regulatory submissions and approvals in the country for the PH portfolio enabling the achievement of business strategic objectives as well as for ensuring regulatory compliance. Priority setting and flexibility are constantly needed.
  • Develop and execute HA interaction plan to obtain Health Authorities buy-in to Bayer’s Regulatory strategies’
  • Responsible for probability assessment of approval permitting optimal business planning.
  • Actively lead and contribute to the development of measures in order to increase approval chances based on a solid knowledge of drug development.
  • Operating in a highly regulated environment that is constantly changing, the RA head provides input and insights for regulatory probability assessments, anticipating these changes when making probability assessments based on experience and knowledge of the environment. Building relationships with the Health Authorities, as key customers essential for achieving business goals. The relationship is based on trust, transparency and partnership and is clearly a major focus of this function.
  • Maintain compliance with all relevant regulatory requirements with no supply disruption due to lack of regulatory oversight
  • Put in place and maintain system for archiving of regulatory documentation with easy access to regulatory history and regulatory documents
  • Secure and maintain compliant product licences, product labelling and participate in promotional material review/approval for a product range, including optimisation of shared labelling where feasible
  • Provide high quality and timely support and regulatory information

 
 
  • Responsible for continuous staff training and people development. Ensure RA and relevant stakeholders in are aware of relevant local regulatory requirements and changes within local regulatory environment, knowledge sharing and best practices sharing to deliver best possible business outcomes
  • Success of the position is measured through the strategic goals achievement of PH
  • Responsible for managing regulatory affairs departmental budget
  1. Work relations
External
  • Health authorities
  • industry associations
  • local third parties
  • Other government bodies: Ministry of Health, Market access & Pricing
Internal:
  • Regional Heads Regulatory Affairs
  • Local PH & CH CDH and business functions
  • Local Medical functions
  • Local Quality functions
  • Local/Regional/Global Product supply
  • Local Legal department
  • Regional/Global Regulatory functions
  • Other RA country managers
  1. Qualifications
  • Master’s Degree in Life Sciences or equivalent scientific degree with a minimum of 7-10 years pharmaceutical industry experience in regulatory affairs with at least 5 years of proven leadership role experience with PH health authority interactions and negotiations, in managing projects and resources and demonstrated track record of providing workable solutions to complex regulatory problems.
  • Sound product knowledge and hands on experience, including successful bridging strategy development, across wide product portfolios and various types of applications and across various types of therapeutic areas, including medical devices and Consumer Health highly desired.
  • The successful candidate will have the requisite experience to act as an effective business partner to country division heads. He/She will need to be a self-starter with excellent interpersonal and communication skills to facilitate the ability to negotiate and influence others, while dealing with issues which have considerable scientific and regulatory uncertainty
  • Analytical capability to evaluate complex/ambiguous situations and to proactively identify potential issues and future trends and to translate into business cases. Ability to come up with solutions to deal with heterogenous environment.
  • Ability to focus on multiple issues at one time, ability to organize, prioritize and direct diverse activities in a changing environment often under time pressure.
  • Excellent managerial, leadership and interpersonal skills to lead and motivate cross functional teams and direct reports, in line with our company LIFE values and to effectively support the PH business and RA goals. Proven track record of building high performing team incl. change management.
  • Solid and demonstrated knowledge of all compliance aspects related to the regulatory affairs function.
  • Thorough knowledge of company policies and procedures. Detailed understanding of the process and policies of the national agency or extensive experience with a related national health authority.
  • Analytical capability to evaluate complex/ambiguous situations and to proactively identify potential issues and future trends and to translate into business cases. Ability to develop effective solutions to diverse and complex business problems, recognizing business needs, thinking strategically and develop risk mitigation strategies.
  • Exposure to wide range of business activities and projects, including in-licensing and out licensing projects
  • Global understanding of Regulatory Affairs and good working knowledge of regulatory framework in EU, US and International Standards (e.g. ICH, GCP, GMP) highly desired
  • Other non-financial figures describing the complexity of the position (e.g. number of clients, administrative reports, products or projects)