Mumbai or Vadodara India

Associate Manager Regulatory Affairs – India

Based in Mumbai or Vadodara India

Full time, permanent position

Competitive salary, bonus and benefits

If you are a Regulatory Affairs Specialist with extensive knowledge of new Marketing Authorization Applications in the EU and ROW regulatory framework and guidelines, then we want to hear from you!

Join us to help improve peoples’ lives and make healthcare better for everyone!

Why Pharmanovia?

Pharmanovia is a dynamic, fast-growing international pharmaceutical company with a portfolio of over 20 brands across more than 140 markets. Our mission is to improve patient health globally through the revitalisation of niche, tried-and-trusted medicines.

Since its inception in 2013, Pharmanovia has grown consistently year on year, focusing on delivering high-quality branded prescription medicines to patients, prescribers and healthcare providers across the world. Our growth has enabled the company to reinvest in its products, brands, people, and to give back to its communities. A people business with a strong, supportive culture that encourages innovation and entrepreneurial spirit, our team comprises over 250 employees and 29 nationalities, operating from offices in the UK, Denmark, Netherlands, Switzerland, U.A.E., India, Singapore, Italy, and South Korea.

We are an agile and imaginative global specialty pharma business and a preferred partner for innovator pharma companies, instigating a paradigm shift in the life cycle management of iconic medicines. We seek to extensively engage with clinical communities to communicate product improvements and prioritise environmental, social, and governance considerations across the business and workforce.

Pharmanovia’s therapeutic areas include Cardiovascular, Oncology, Endocrinology and Neurology.

The role:

  • Provides strategic and operational regulatory support to project management on new divestment projects, technical transfer, CMOs, quality assurance and commercial departments.
  • Leads the preparation of core dossiers and submissions for global roll out.
  • Authors, reviews and approves M3 dossier sections as necessary, justification documents and Product Information.
  • In collaboration with global partners, consultancies and distributors, outlines global regulatory intelligence and form a global regulatory strategy.
  • In collaboration with senior management and project strategy teams, develops and reviews global cross functional regulatory strategies.
  • Ensure diligent reporting and progress updates on regulatory workload at weekly/bi-weekly internal regulatory meeting.
  • Negotiates and makes agreements on behalf of the department.
  • Interprets applicable regulations and guidelines for project team use.  Keeps project team abreast of regulatory decisions, evolving regulatory requirements, risks and mitigation plans.
  • Serves as a primary contact to the local health authority (HA(s), local consultancies/ distributors and internal stakeholders, to ensure timely and accurate submissions.
  • Facilitates communication between the HA(s) and the project team.
  • Coordinates and solicits components of the submission from various functional areas, distributors and CMOs.
  • Proactively identifies project issues to the project team and supports mitigation plans.
  • Attends cross functional meetings, vendor meetings and kick-off meetings as required.
  • Mentors and/or manages Regulatory Associates and other junior level or administrative Regulatory staff.
  • Maintains a high level of professional expertise through familiarity with scientific literature and participation in training courses.
  • Responsibilities may include interviewing, hiring, and training employees; planning, assigning, and overseeing regulatory submissions.

About you:

  • Bachelor’s / Master’s degree is required in a Scientific/health related field.
  • Generally, has at least 7 years of related experience within a pharmaceutical company, CRO, CMO or similar. 
  • Your regulatory experience should be broad as a “generalist” regulatory professional.
  • Must be able to communicate comfortably and effectively with regulatory authorities.
  • Must be able to independently present complex global regulatory strategies internally and to partners. 
  • Strong knowledge of EU regulatory framework and guidelines.
  • Awareness of emerging markets submission rollouts.
  • Expertise in regulatory submission structure and content (e.g., MAA, NDA).
  • Experience in compliance and maintaining product life cycle data bases and RIMs systems.
  • Ability to work successfully within a cross-functional team.
  • Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling, and meeting deadlines. 
  • Must be able to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands.
  • Expertise to write scientific and technical documents.
  • Proven ability to independently resolve problems.
  • Strong knowledge of MS Word, Excel, PowerPoint, Project and Outlook.
  • Global regulatory strategy and deployment decisions; defining strategic priorities.
  • Ability to work independently, take initiative and complete tasks to deadlines.
  • Strong Communication skills.

What we offer:

We offer a competitive salary plus bonus and rewards package including holiday, health & wellbeing program, employee recognition awards, social events and hybrid working.

By applying for this role, your details will be sent to Ortolan People, who are engaged to provide recruitment support in processing applications. We will endeavour to respond to all applicants within three working days. Occasionally for roles with a very high volume of applicants, this may not be possible.

Apply now and become part of our team

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