Careers

We are inviting applications for the role of Regulatory Consultant. We are looking for dynamic, driven individuals with strong initiative who can thrive in the entrepreneurial environment at our firm.

Role & Responsibilities:

The person will be responsible for project specific regulatory consulting services at the firm. The responsibilities of this position include, but are not limited to, the following:

• Complete ownership for all regulatory projects including dossier writing, submissions, approval tracking, query resolution across Developed and Emerging markets
• Ensure regulatory compliance, accuracy, timely completion, version control & adherence to internal SOPs
• Providing strategic input to the Management and Partners on regulatory projects
• Keep abreast of new developments in regulations across all critical health authorities

Experience & Qualifications:

• Formal regulatory affairs experience for a minimum of 8 years. Experience with a consulting company & a previous managerial role would be considered an advantage
• Experience with 505(b)(2) and 505(j) ANDA writing, ANDS submissions and approvals, experience in using eCTD software for publication.
• Experience in DCP filing and m1-m5 CTD writing for EU, Australia, Canada
• Computer and technical skills (including eCTD software knowledge)
• Strong & Flawless communication skills.
• Accuracy and attention to detail.

Location: Navi Mumbai

We are inviting applications for the role of Consultant – GMP. We are looking for dynamic, driven individuals with strong initiative who can thrive in the entrepreneurial environment at our firm.

Role & Responsibilities:

This will be an individual contributor role and the person will be responsible for GMP consulting (EU GMP & PIC/S) with specific expertise in manufacturing areas, utilities, and vendor qualifications at the client site. The responsibilities of this position include, but are not limited to, the following:

• Evaluation, gap assessment and resolutions of concerns pertaining to manufacturing areas, utilities, and vendor qualifications
• Identifying gaps for facility, QC and Documentation and ensuring adherence to compliance requirements.
• Participating in internal audit and preparation of relevant reports.

Qualification & Skills:

• M. Pharm is minimal requirement.
  Formal production & utility experience for a minimum of 5-8 years.
• A previous vendor qualification role would be considered an advantage.
• Candidate should have faced USFDA/ EU GMP inspections and inspections from other leading authorities.
• Strong & Flawless communication skills.
• Accuracy and attention to detail.
• Candidate should be willing to travel frequently in India and Internationally.

Location: Navi Mumbai

We are inviting applications for the role of Sr. Executive: Project Management & Business Development. We are looking for young, dynamic, driven individuals with strong initiative who can thrive in the entrepreneurial environment at our firm.

Role & Responsibilities:

The person will be in an individual contributory role and will be responsible for end-to-end Project Management & BD activities for the consulting services at the firm. They will also hold responsibility for the project management of the pharmaceutical product portfolio of the company.

The responsibilities of this position include, but are not limited to, the following:

• Oversee the project management of the Consulting projects & the pharmaceutical product portfolio, ensuring that key timelines and milestones are met as per the agreed plan with the client.
• Contribute actively towards project planning, initiation, execution, tracking, monitoring, and facilitating the completion of the pharmaceutical product portfolio of the company.
• Lead Cross Functional Team meetings to track & monitor projects and to apprise Management of the progress through Monthly MIS.
• Monitors resources, revenue and capital costs against the project budget
  Manages expectations of all project stakeholders.
• Facilitates open communication and discussion between stakeholders, acting as a single point of contact by developing, maintaining and working to stakeholder engagement strategies and plans.
• Work closely with Manager Business Development for prospecting clients, tracking new enquiries, draft proposals with the scope of work and convert new business for the company.
• Work on new product business cases and assist in negotiation and closure of agreements.
• Travel frequently to attend client meetings and conferences (national/international), as needed for expanding new business.

Experience & Qualifications:

• Graduate/ Post Graduate degree in Pharmaceutical Sciences. An MBA from a premier institute would be considered as a strong advantage.
• Formal pharmaceutical project management experience for a minimum of 2 years.
• Experience in Business Development & Commercial front would be considered an advantage
• Strong & Flawless communication skills.
• Must have a basic understanding of project financial tracking; Ability to provide input to financial plans and forecasts
• Strong time management skills, with the ability to work under pressure and adhere to deadlines
• Accuracy, diligence and attention to detail.
  Proficiency in MS Excel, MS PowerPoint