Regulatory Affairs Specialist
About the Role
The Regulatory Affairs Specialist, reporting to the Head of Alliance and India Office, will play a pivotal role in providing regulatory expertise to Medicines Patent Pool (MPP) licensing activities. They will guide the MPP team and partners on global regulatory processes and lead the development and enhancement of the MPP regulatory database for healthcare products across Low- and Middle-Income Countries (LMICs).
Job Description
Regulatory Activities:
- Take ownership of the Regulatory Database development initiative, focusing on regulatory requirements for various product categories in LMICs.
- Collect, interpret, and verify raw data for the Regulatory Database, managing the project lifecycle until successful launch.
- Analyze and track regulatory landscape changes across LMICs for specified product categories, ensuring ongoing database maintenance.
- Stay updated on guideline changes from ICH, FDA, WHO-PQ, EMA, and other regulatory authorities.
- Engage with regulators to identify regulatory pathways for MPP licensees.
In Licensing:
- Provide regulatory guidance to facilitate identification and prioritization of suitable in-licensing candidates.
- Conduct regulatory assessments of selected products for in-licensing.
- Contribute to feasibility studies and develop business cases for in-licensing.
- Provide regulatory inputs during license negotiations and agreement finalization.
Out Licensing:
- Participate in Expression of Interest process and selection of out licensing beneficiaries.
- Monitor development activities and regulatory filings by MPP sublicensees.
- Maintain communication with sublicensees and identify areas for regulatory support to accelerate processes.
- Support Alliance Management team in fostering effective partnerships.
Other Responsibilities:
- Provide regulatory inputs to case studies within MPP.
- Collaborate with legal, policy, market access, technology transfer, and communications teams, offering regulatory insights.
- Perform other duties as assigned.
Candidate Profile
- University degree in Pharmacy or related discipline with strong regulatory background.
- 10+ years of regulatory affairs experience in pharmaceutical industry.
- Solid understanding of generic drug registration process, particularly in emergent markets.
- Ability to manage multiple projects effectively.
- Proficiency in regulatory guidelines from major authorities.
- Native-level fluency in English.
- Experience in handling registrations of different product categories and dosage forms.
- Knowledge of intellectual property and voluntary licensing.
- Interest in public health and access to medicines in low-resource settings.
- Understanding of general NCE registration process.
Personal Qualities
- Autonomous, self-motivated, and able to work independently or collaboratively.
- Strategic and analytical thinker with problem-solving skills.
- Ownership attitude with excellent organizational abilities and flexibility.
- Adaptable to diverse work styles and cultures.
- Strong relationship-building skills, able to gain trust and foster successful negotiations.
Additional Information
- Qualification: University degree in Pharmacy
- Experience: 10+ years
- Location: Mumbai, India
- Industry Type: Pharma/ Healthcare/ Clinical research
- Functional Area: Regulatory Affairs
- End Date: 30th May 2024
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