Location: Mumbai – Andheri East, Maharashtra, India, with frequent travels up to 25% of the working time.
The Medicines Patent Pool (MPP) is a United Nations-backed public health organisation working to increase access to, and facilitate the development of, life-saving medicines for low- and middle-income countries. Through its innovative business model, MPP partners with civil society, governments, international organisations, industry, patient groups and other stakeholders, to prioritise and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations. To date, MPP has signed agreements with ten patent holders for thirteen HIV antiretrovirals, one HIV technology platform, three hepatitis C direct-acting antivirals and a tuberculosis treatment. MPP was founded by Unitaid, which serves as sole funder for MPP’s activities in HIV, hepatitis C and tuberculosis. MPP is now expanding its activities to cover essential medicines, which requires engagement with many new stakeholders, including potential funders.
For more information, please see our website, https://medicinespatentpool.org/
The BDM – Technical & Regulatory Affairs works under the supervision of the BDM – Head of Alliance Management (based at the head-office in Geneva (Switzerland)) as part of a dynamic and international team to provide technical expertise in our out-licensing activities.
- Provide professional technical drug development expertise and strong leadership in applicable guidance and regulations (regulatory affairs) to generic manufacturers (MPP Licensees).
- Proactively identify potential technical areas of supporting generic manufactures developing the most appropriate formulations in the most effective way.
- Closely work with generic manufacturers to ensure the implementation of the most appropriate regulatory path for a given compound/formulation to be approved in the shortest time.
- Troubleshooting on technical development/manufacturing and regulatory processes that generic manufactures might face.
- Effectively coordinate with the team to ensure alignment on alliance management and technical development activities.
- Participate in the quarterly meeting reviews (F2F and remote meetings with generic manufacturers) and reporting on those. Subsequently ensure the timely and accurate reporting that allows the team to report back to originators (patent holders).
- Support the development and implementation of feasibility studies (in relation with the evaluation of manufacturing and regulatory capabilities amongst generic manufacturers).
- Closely work with the MPP team in charge of the Expression of Interest process to manage the selection of generic manufacturers (out-licensing).
- Explore strategies to increase accuracy, efficiency and effectiveness of the development/manufacturing and regulatory activities performed by the generic manufacturers.
- Closely monitor FDA, WHO-PQ and other Stringent Regulatory Authorities guidelines updates.
- Liaise with Institutional stakeholders when appropriate (e.g. Ministry of Health).
- Represent the team and/or MPP at external relevant forums.
- Perform other duties as assigned by the BDM – Head of Alliance Manager or by the Head of Business Development.
- Solid understanding of the drugs technology, development and regulatory processes.
- Knowledge of the therapeutic and partnering landscape within a sector of interest to MPP is a plus.
- Project management skills – Proven ability to manage multiple projects effectively in a fast-paced environment.
- Ability to permanently improve processes to use resources in an optimum way.
- Experience working with/in developing countries (emergent markets) is a plus.
Education and special training:
University degree in Pharmacy or any other related discipline with strong scientific/technical component.
Experience (length and nature):
Around 10 years of experience in the pharmaceutical industry – drug development position a must. Experience with regulatory affairs an advantage.
Use of Languages:
Native-level fluency in English is required.
MPP’s richness lies in its staff: a small dynamic and multicultural team!
To flourish in our team, you must recognise yourself in our values: Respect, Courage, Teamwork and Commitment.
Moreover, the BDM – Technical & Regulatory Affairs will need to demonstrate the following qualities:
- Demonstrable personal commitment to the public health goals of the MPP.
- Energetic and result-driven.
- Organisation skills, autonomy and ability to work within short timelines.
- Self-starter with a strong executive presence.
- Ability to work strategically and analytically, creatively and proactively in a problem-solving environment.
- Ease with multi-stakeholders environment.
- Collaborative and supportive approach to teamwork.
- Sensitivity to different cultures and work styles.
MPP respects all individuals regardless of race, gender, ethnicity, sexual orientation, religion, HIV status or disability. All qualified applications are welcome.
If you recognise yourself in this description and wish to join our outstanding team, please send a cover letter and C.V. to firstname.lastname@example.org including “BDM – Technical & Regulatory Affairs” as reference in the subject line by 19 April 2020.
Please note that due to the current health crisis, this recruitment process may be potentially delayed.