The Regional Regulatory Policy Lead role leads the regional Regulatory Policy activities. The objective of this role is to Developing and executing a regional policy roadmap and associated Roche positions to drive global regulatory convergence in the best and most sustainable interest of Roche.
Ensuring alignment and regulatory stakeholder engagement within PD, PT, Government Affairs, DRAs in the region as well as external interest groups according to PDR Policy priorities.
The main Responsibilities and Accountabilities are :
Develops and implements strategic plans and objectives for priority areas for Regional Market regulatory convergence and advocacy, and effectively engages in international forums such as EFPIA, IFPMA Networks, local trade associations and DIA in enabling long term regulatory convergence.
Manages and has command of all Roche regulatory policy activities for the region including oversight on requirements, legislations and regulatory environment.
Supports the development of Roche regional positions on key topics relevant to Pharma Development and advocates effectively such positions in external forums.
Ensures organizational awareness, alignment and support for identified topics as well as respective position development for all regional aspect.
Lead planning and organization of educational workshops with relevant local and regional agencies to enhance capacity building in the respective region.
Supports overall Roche efforts for strong health authority relationships through effective communications, interactions and participation in meetings, conferences and committees with focus on the region.
Builds and maintains relationships based on trust and respect with trade organizations and actively engages and leads industry or scientific task forces of importance to Roche priorities.
Collaborates and partners with other Policy Teams within the organization (Pharma Technical Regulatory policy, EU and US policy, Government affairs, Policy Governance committees, External Interactive Steering Committee, Regional Policy leads and also other related functional groups e.
g. legal, clinical science).
Is the primary contact for affiliates in the region on PDR policy requests and questions to filter and triage at corporate level.
Represents Roche regulatory policy views in the region during external stakeholder engagement.
Serves as a deputy to the Global Head of International Regulatory Policy, as required.
The expertise required (Qualifications, Experience, Knowledge and Competencies) for the role are :
University degree, preferably in a scientific / technical discipline, additional business or science degree is a plus
Long and broad (preferably 10+ years) professional experience within the pharmaceutical industry, in development and / or technical function at a global level, preferably in policy with at least 3 years
Successful track record in developing and pushing through product related regulatory strategies
Strong knowledge and experience of the drug development process before and after launch
Hands on functional participation in several global Phase 0 IIII product development programs, post approval variations and line extensions.
Experience and track record of making decisions and aligning the organization behind them
Capable of establishing and maintaining relations and leadership responsibilities in major scientific and industry associations
Existing network with regulators and industry peers
Has made impactful presentations to senior management and the external environment
Has demonstrated leadership of cross-functional teams
Relevant scientific and regulatory knowledge
Pharmaceutical industry knowledge and understanding / experience with drug discovery and commercialization process
Understanding of regulatory environment and trends as well as the business context
Fluency in written and spoken English and other languages
We are looking for passionate candidates with the next competencies :
High ethical standards
Ability to demonstrate Roche Values and Leadership Commitments
Roche Core Competencies
Functional competencies, including but not limited to, organization, prioritization and planning skills, negotiation skills, communication & presentation skills
Strong inspiring, influencing, engaging and motivating capabilities
Strategic thinking and analytical skills
Conflict and change management skills
Ability to work across multiple cultures and countries
Ability to operate successfully in a global matrix environment with shared accountability and responsibilities
Fluency in written and spoken English and Spanish, Portuguese would be an advantage
Travel to affiliates and conferences as needed (20% - 30%)
If you are a professional that seeks for new challenges as Regional Regulatory Policy and have the following characteristics, please apply directly in our web page
Who we are Roche Mexico has more than 1000 employees and sells more than 50 primary care and highly specialized medicine on a 100 diagnostic products catalogue.
Roche it's part of 5 most important pharmaceuticals companies in Mexico.
Roche is an equal opportunity employer.