Director - Regulatory Affairs, Competitive Strategy, Gurugram

Director Regulatory Affairs, Competitive Strategy

India – Gurugram

About You

Do you want to play a critical role in leading and advising internal stakeholders in the domain of regulatory affairs for the EU and US? Prescient is offering the ideal opportunity for executives with deep knowledge of regulatory affairs to continue to develop their expertise, to keep abreast of new regulatory developments and to build on their commercial experience. Do you have:

• Experience of providing advisory services on regulatory affairs in the EU and US regions concerning the biopharmaceutical sector?
• Deep knowledge of the EU and US regulatory environment and market dynamics?
• Experience of monitoring regulatory changes, providing updates that elucidate the implications of those changes and potential issues arising from them, and advising on effective resolutions?
• The ability to communicate with impact, both verbally and in writing, and to operate effectively as part of a single, united team?
• Attention to detail, efficient time-management skills, professionalism and a strong work ethic?
• Excellent people and stakeholder management skills and the ability to mentor junior team members for their professional growth?

If so, consider turning your expertise into a valuable career at Prescient.

About Prescient Competitive Strategy

Prescient Intelligence & Insight, a Prescient Healthcare Group business, is a best-in-class biopharma intelligence agency providing impactful insight and decision support to product and portfolio teams from early clinical development through to loss of exclusivity.

About the Opportunity

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

Key Responsibilities

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

Required Experience and Skills

• 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

Personal Specifications

The successful candidate must demonstrate the following attributes:

• Professionalism: Using both formal and informal processes to obtain feedback on performance and development; developing expertise to meet strategic priorities and company requirements
• Accountability: Consistently delivering to expectations and commitments; meeting or exceeding agreed standards by coming up with new ways to overcome challenging circumstances; tracking progress and resolving issues promptly where necessary; taking full responsibility for meeting client expectations and company goals.
• Attention to Detail: Rigorously ensuring accuracy, consistency and quality across all aspects of the role; believing that the respect and trust of our clients and colleagues must be continuously earned through work excellence
• Ethical Behaviour: Acting and encouraging others to act in line with company and client codes of conduct; accepting responsibility and taking remedial and developmental action when mistakes are made; skilfully managing conflicts and sensitive issues within the team; representing the company and promoting its reputation to a high standard
• Team Interaction: Uniting team members to ensure their work benefits from diverse input, promoting a team ethos across the company and ensuring continued collaboration through effective communication
• Decisiveness: Making informed decisions after careful evaluation of multiple sources and application of intuition and judgment, and upholding company priorities throughout

What We Offer

• Competitive package and remuneration linked to performance
• High-growth, entrepreneurial environment where you can create significant business value and forge your own path
• Platform for accelerated professional development and career growth with significant levels of responsibility and accountability

About Prescient Healthcare Group

Prescient® is a pharmaceutical services firm specialising in dynamic decision support and the development of product and portfolio strategies. We partner with our clients to turn science into value by helping them understand the potential of their molecules, shaping their strategic plans and allowing their decision making to be the biggest differentiating factor in the success of their products. When companies partner with Prescient, the molecules in their hands have a greater potential for success than the same science in the hands of their competitors.

Founded in 2007, Prescient is a global firm with a footprint in 10 cities across three continents. Our team of nearly 475 experts partners with 27 of the top 30 biopharmaceutical companies, the fastest-growing mid-caps and cutting-edge emerging biotechnology companies, including some of the biggest and most innovative brands. More than 70% of our employees hold advanced life sciences degrees, and our teams deliver an impressive depth of therapeutic, clinical and commercial expertise.

Prescient has been a portfolio company of Bridgepoint Development Capital since 2021 and Baird Capital since 2017. For more information, please visit www.prescienthg.com.

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.