Position Title - Director – Regulatory Affairs,

Function - Competitive Strategy 

Location – Gurugram

Position Overview

As a Director – Regulatory Affairs, Competitive Strategy, your time will be divided as follows:

• 80% providing regulatory affairs and development expertise to our teams in an advisory capacity to ensure the data and analytics produced by the teams are of high quality across diverse therapy areas, especially oncology, immunology, neurology and CVRM
• 20% on mentoring and lending business development support

You will be part of a fast-growing PE-backed business that allows high-performing employees to make an impact and contribute to growing the business. You will play a critical role in both leading and advising on client engagements, ensuring the analysis, implications and recommendations delivered to clients are accurate and impactful.

The successful candidate will serve as a primary point of contact for any regulatory queries for stakeholders, and formulate and recommend effective resolution to the issues.

• Reporting: You will report to a senior executive within Prescient’s India office
• Time Allocation: 90% of your time will be spent in the local office and the remainder undertaking potential domestic and international travel to clients, conferences and other Prescient offices

To learn more, please visit us at: www.prescienthg.com.

Example Responsibilities

The following are example responsibilities of this position and are, as such, not meant to be exhaustive, nor convey every responsibility that may vary over time, without changing the essence of this position:

The primary focus of the Director – Regulatory Affairs, Competitive Strategy will be on:

• Subject Matter Expertise: Providing regulatory affairs and development expertise to our teams in an advisory capacity; helping guide the direction of research and working with teams to maximise the impact of their analysis and recommendations
• Monitor regulatory changes and advise on their implications for Prescient’s offerings
• Serve as the primary point of contact for regulatory queries for internal stakeholders and resolve their issues
• Engagement Leadership: Acting as the final arbiter of quality, accuracy, consistency and impact across a portfolio of engagements that include regulatory aspects; serving as a thought partner for internal stakeholders in regulatory affairs
• Team Mentorship: Working with our People, Performance & Culture function to expedite the development of our teams; providing consistent mentoring and feedback within the engagement setting; developing and delivering formal training modules; making podium presentations and networking at relevant conferences and forums
• Thought Leadership: Developing challenging and impactful thought leadership pieces and publishing peer-reviewed articles; keeping abreast of conferences and advances in regulatory affairs.
• Business Development Support: Acting as a subject matter expert on regulatory affairs in the development of proposals and the delivery of pitches

Education, Experience, Knowledge & Other Skills

The following criteria outline the minimum hiring criteria for this position, unless otherwise stipulated below as “preferred,” or “a plus.”

• A master’s or higher degree in biomedical sciences
• At least 15 years’ experience, including a minimum of 12 years of relevant regulatory affairs and clinical development experience, gained from working within the pharmaceutical industry or regulatory affairs consultancy
• Demonstrated experience and robust knowledge of regulatory affairs for the EU and US
• Analytical skills, with the ability to collect, organise and disseminate significant amounts of information with attention to detail and accuracy
• Ability to generate value-adding advice with the aim of resolving regulatory issues effectively
• Knowledge of drug development and commercialisation regulations as well as regulatory bodies, with the ability to monitor regulatory changes
• Familiarity with data science tools such as Tableau and Power BI will be an advantage
• Proficiency in the use of Microsoft Office applications, especially PowerPoint and Excel
• Fluency in English

We are committed to doing our part in the broader communities in which we work and live. As such, all employees will play their part in supporting our broader business mission, vision, purpose and the Prescient brand as well as our commitment toward optimising the social and environmental elements of our communities. We will support these efforts by ensuring regular communications, periodic trainings, volunteering, and other relevant activities. People managers will play a particularly active role in this by assuming responsibilities for certain social and environmental activities that we support as an overall organisation.

We are an equal opportunity employer and fully comply with applicable legislation in all the geographies in which we operate. Applicants are considered for positions without regard to veteran status, uniformed service member status, race, colour, religion, sex, national origin, age, physical or mental disability, genetic information or any other category protected by applicable national, federal, state, or local laws.