Call for Applications – Business Development Manager – Technical and Regulatory Affairs

Location: Mumbai, India with frequent travels up to 25% of the working time within India and occasional abroad travels.

Working time: 100% 

Contract: permanent

1. Main Duties/Responsibilities

This is a newly created role, which is a key member of the business development team, who will  report directly to  Technical and Regulatory Affairs Manager and directly assist the Head of Business Development and the Technical and Regulatory Affairs Manager in meeting the strategic, scientific, therapeutic, and commercial needs of MPP through the in-licensing and out licensing of target pharmaceutical assets and associated development & manufacturing technologies.

• Directly assist the Head of Business Development and BDM, Technical and Regulatory Manager in the following in licensing activities:
  • Provide technical and regulatory inputs to the scientific team in identification and prioritization of suitable candidates for in licensing
  • Support the feasibility studies in in licensing process by providing technical and regulatory assessments on different candidates
  • Support in conducting consultation calls with the potential partners as a part of feasibility studies for in licensing of different candidates (in relation with the evaluation of manufacturing and regulatory capabilities amongst generic manufacturers)
  • Work closely with the in-licensing team in preparing business case for in licensing of suitable candidates
  • Provide technical and regulatory inputs during license negotiations with the originator, and finalization of term sheet and agreements
• Directly assist the Head of Business Development and BDM, Technical and Regulatory in the following out licensing activities:
  • Support the MPP team in charge of the Expression of Interest process to manage the selection of generic manufacturers (out-licensing)
  • Interact extensively with MPP sublicensees and participate in the quarterly meeting reviews (F2F and remote meetings with generic manufacturers)
  • Track and monitor development activities and regulatory filings by MPP sublicensees.
  • Proactively identify critical areas of concern and bottlenecks with respect to product development and support the sublicensees with technical and regulatory inputs to accelerate development and filing process.
  • Work closely with Alliance management team and support wherever required in ensuring effective alliance management for both MPP sublicensees and Originator companies
• Provide technical and regulatory inputs on case studies carried out within MPP
• Update and maintain the internal MPP Regulatory Database on regulatory requirements of different product categories in LMICs. Analyse, monitor and track the regulatory environment in different LMICs with respect to registration of medicinal products.
• Closely monitor FDA, WHO-PQ and other Stringent Regulatory Authorities guidelines updates.
• Closely monitor and analyse the R&D pharmaceutical industry including new development and manufacturing technologies, long-acting technologies, novel small molecules, biotherapeutics, medical devices etc related to disease areas of public health importance
• Participate in cross-functional collaboration with legal, operations, policy, communications, technology transfer teams where BD input is required to achieve MPP’s mission.
• Perform other duties as assigned by the by the Head of Business Development and BDM – Technical and Regulatory

2.Knowledge/Qualifications

• Solid understanding of the generic and NCE drug development process in terms of product development, Bioequivalence, registration and commercialization
• Thorough knowledge of pharmaceutical manufacturing processes and technology transfer
• Knowledge of different product categories (small molecules, biologics, vaccines etc) and different dosage form (solid oral, injectables etc) is preferable
• Project management skills – Proven ability to manage multiple projects effectively and meet deadlines.
• Experience of working in developing countries (emergent markets) and understanding of LMIC regulatory landscape is a plus.

3. Personal Skills

• Autonomous with strong self-motivation and ability to work independently as well as in a highly collaborative environment within short timelines.
• Ability to work strategically and analytically, creatively, and proactively in a problem-solving environment.
• Ownership Attitude – ability to set priorities and meet specific deadlines in a rapidly changing global environment while flexible enough to adapt to global differences in work style and culture.
• Organizational Effectiveness– ability to gain trust of high-level management and leverage relationships to yield successful negotiations and long-term organizational relationships.
• Experience of working in a complex environment with a track record of accountability and execution.
• Ability to gain commitment from team members and other colleagues to act on strategies, plans and goals.

4. Education and Special Training

• Advanced university degree preferably in one of the following fields: Science, Pharmacy
• In depth knowledge of conducting literature survey from regulatory websites, FOIs and assessment reports, scientific journals, patents etc.
• Proficiency in MS Office (excel, presentation etc)

6. Experience (length and nature)

• Circa 8 years of relevant experience

7. Use of Languages

• Native-level fluency in English is required.

8. Personal Qualities

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, Generosity and Commitment.

Moreover, the Technical and Regulatory Affairs Manager will need to demonstrate the following qualities:

• Organised, autonomous, and able to work within short timelines and new areas
• Extremely meticulous and excellent attention to detail
• Supportive team player with demonstrated interpersonal, collaborative and conflict mitigation approach
• Ability to work with relatively senior and more experienced people especially those outside the direct sphere of influence
• Sensitivity to different cultures and work styles
• Friendly personality

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 recruitment@medicinespatentpool.org including “BDM Technical and Regulatory” by November 23^rd 2022.