Assistant Manager-Project Management

Rubicon Research Limited is a fast-growing pharmaceutical formulation company delivering value to our customers and investors by developing, manufacturing, and marketing branded specialty and generic prescription pharmaceutical products in regulated markets.

Our product portfolio comprises over 250 SKUs across more than 70 product families. We have an established marketing, sales, and distribution platform in the US through our subsidiaries AdvaGen Pharma which markets non-branded prescription products, and Validus Pharmaceuticals which markets branded prescription products and promotes them to healthcare practitioners in the US.

We have two US FDA-inspected R&D facilities – one each in India and Canada, and two manufacturing facilities in Maharashtra, India with multiple accreditations from multiple regulatory agencies such as US FDA, Food and Drugs Administration, Maharashtra (WHO-GMP accreditation) and Health Canada. Our facilities are equipped with various drug development and manufacturing capabilities across dosage forms.

Headquartered in Thane, India we have a sales and marketing office in New Jersey, USA.

For additional information visit www.rubicon.co.in

Position Title:

Type:

Location:

Department

Job Summary:

incumbent -

Key Responsibilities:

Project Planning & Execution:

• Develop and maintain

  project timelines, budgets and risk mitigation plans

  to meet critical milestones
• Manage pipeline of

  505(b)(2) and complex generic product development

  projects
• Ensure compliance with FDA’s r

  egulatory requirements

Regulatory & NDA Submission Strategy:

• Coordinate pre-NDA meetings and address FDA queries during the review process.
• Ensure

  CMC (Chemistry, Manufacturing, and Controls) readiness

  for regulatory submissions.
• Work closely with Regulatory Affairs teams to support

  NDA, and ANDA

  filings.

Cross-Functional Leadership & Stakeholder Management:

• Collaborate with R&D, Clinical, Regulatory, Supply Chain and Commercial teams to ensure project alignment.
• Ensure project governance meetings and provide regular updates to senior leadership.
• Engage with

  external partners (CDMOs, CROs, CMOs, API suppliers, KOLs)

  for project execution.

Risk Management & Problem Solving:

• Identify and mitigate technical, regulatory and commercial risks

  associated with new or complex dosage forms

  .
• Resolve project bottlenecks by driving proactive solutions with cross-functional teams.

Qualifications & Skills:

• Education:

  M. Pharm or PhD, in Pharmaceutical Sciences or related field. MBA is a preferred in addition to M. Pharm.

• Experience:

• 5-7 years

  of experience in

  pharmaceutical project management

  , with a focus on NDA, 505(b)(2) and complex generics.
• Proven track record in

  NDA submissions and approval processes

  .
• Experience with

  injectables, inhalation/nasal sprays, transdermal, liposomes, peptides, long acting injectables, OSD, or other complex drug delivery systems

  .

• Project Management Skills:

• Proficiency in

  MS Project, Excel or other project management tools

  .

• Regulatory Knowledge:

• Strong understanding of

  FDA, and ICH guidelines

  for NDA and complex products.
• Hands-on experience with

  CMC, Clinical & Regulatory aspects of NDA filings

  .

• Soft Skills:

• Excellent communication and stakeholder management skills.
• Strong problem-solving, analytical, and leadership capabilities.
• Ability to manage multiple projects under tight deadlines.

Preferred Experience:

• Experience working with

  CDMOs, CROs, and external partners

  for product development.
• Knowledge of

  cGMP, ICH, and pharmaceutical quality systems

  .

Qualifications & Skills:

• Education:

  M. Pharm or PhD, in Pharmaceutical Sciences or related field.
• Proven Track record in Project Management.