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Deputy Head of Regulatory Affairs

ABOUT US:

Pharmanovia is a fast-growing pharmaceutical company with a portfolio of over 20 brands across 140 markets. Our team of over 170 employees are based across our offices in Basildon (UK), Copenhagen (Denmark) and Vadodara (India).

We acquire, develop and market a portfolio of mature branded medicines globally:

Acquire -We acquire “mature” (i.e. post-patent expiry), established branded prescription medicines from large cap and specialty pharma.

Develop – We develop line extensions (new formulations or new markets) to the medicines we acquire. We also develop our own niche generic medicines in-house.

Market – We currently own and market a portfolio of more than 18 medicines and operate in more than 130 markets globally.

Our regulatory department is responsible for providing regulatory strategic advice and life cycle maintenance for the portfolio, globally. In addition, support with new product development initiatives.

We seek highly motivated individuals, with strategic thinking to join our growing team.

KEY TASKS & RESPONSIBILITIES:

  • Provides strategic leadership for new divestment projects, commercial growth, technical transfers and process improvements.
  • Develops and oversees regulatory activities focused to provide strategic areas of growth for the business.
  • Supports the hiring and talent management of the department as well as developing forecast of departmental workload. 
  • Mentors and/or manages Senior Regulatory Managers and establishes succession plans across the teams.
  • Participate in skill-development, coaching, and performance feedback of other regulatory staff working on the product/project.
  • Supports Senior Regulatory Managers in the development and onboarding of new processes/systems (eg. RIMS and regulatory intelligence database)
  • Supports budget build and management for the department.
  • Accountable for the workstream responsible for life-cycle maintenance for the portfolio and CMC related submissions in support of technical transfers.
  • Supports building the global infrastructure of global partners, consultancies and distributors including negotiating and making agreements on behalf of the department
  • In collaboration with senior management and project strategy teams, provides oversight for the global cross functional regulatory strategies.
  • Accountable for the delivery of regulatory milestones including assessment of the probability of regulatory success together with risk mitigation measures.
  • Serves as point of escalation for cross functional meetings, vendor meetings and kick-off meetings as required.
  • Maintains a high level of professional expertise through familiarity with scientific literature and participation in training courses.
  • Lead the regulatory staff working on a product/project to ensure prioritized objectives that focus on the critical activities are successfully delivered to time and quality.
  • Ensure effective regulatory representation in partnership with appropriate technical experts at cross-functional technical transfers, health authority meetings and dossier remediation projects.
  • Monitor changes in the regulatory environment, both general and specific to the therapeutic area, and support and advise teams and department staff accordingly.

KEY ACCOUNTABILITIES AND QUALIFICATIONS:

  • Bachelor’s degree in a Scientific/health field
  • Extensive experience within a pharmaceutical company, CRO, CMO or similar organization.  The regulatory experience should be broad as a “generalist” regulatory professional
  • Must be able to communicate and negotiate comfortably and effectively with regulatory authorities.
  • Experience in line management responsibilities of a team, including setting objectives, training and development plans and conducting performance review.
  • Strong knowledge of EU regulatory framework and guidelines and impact assessment of rollouts to emerging markets
  • Expertise in regulatory submission structure and content (e.g. MAA, NDA)
  • Experience in establishing procedures related to compliance and maintaining product life cycle data bases and RIMs systems

BENEFITS:

  • The ability to work from home in accordance with our flexible working policy (although we find that many of our colleague enjoy working from our new offices located in Essex when permitted).
  • We offer a generous bonus scheme.
  • Health care benefits.
  • All of our employees receive a subscription to Perk Box which includes various discounts and benefits.
  • The business hosts a staff party in the summer and Christmas each year and host quarterly town hall events for all staff to attend.
  • There are opportunities to be involved with various charity events hosted by the company.

Apply now and become part of our team

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