Regulatory Affairs Manager

Regulatory Affairs Manager - Mumbai or Vadodara, India (hybrid role: 3 days office, 2 days home per week)

About the Company

Pharmanovia is a dynamic, fast-growing international pharmaceutical company with a portfolio of over 20 brands across more than 160 markets. Our mission is to improve patient health globally through the revitalisation of niche, tried-and-trusted medicines. Our core behaviours are:

• We act decisively but we never compromise on quality.
• We keep our promises and do as we say.
• We value our heritage and foster an entrepreneurial spirit.
• We reinvest in our future – in our products, our brands and our people.
• We give back to our communities.

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 300 employees and 29 nationalities, operating from offices in the UK, Denmark, Netherlands, Switzerland, Italy, Spain, Germany, U.A.E., India, Australia and Singapore. We are an agile, committed, and innovative 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.

About the Role

Our regulatory department is responsible for providing regulatory strategic advice and life cycle maintenance for the portfolio, globally, and additionally supports with new product development initiatives. This role reports directly into the Senior Manager, Regulatory Affairs.

Responsibilities

• 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.
• Ensures 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.
• Attends and generally leads agency meetings, if required.
• 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 other Regulatory Managers, Regulatory Associates and other junior level or administrative Regulatory staff.

Qualifications

• Bachelor's degree in a scientific/health field.

Required Skills

• Excellent IT skills across all MS packages, including Excel, Word, PowerPoint, Project, Outlook, and Teams.
• Experience in compliance and maintenance of product life cycle databases and RIMs systems.
• Strong knowledge of the EU regulatory framework and guidelines, and awareness of emerging markets submission rollouts.
• Global regulatory strategy and deployment decisions, defining strategic priorities.
• Expertise in regulatory submission structure and content (e.g. MAA, NDA).
• Expertise in writing scientific and technical documents, and strong attention to detail in composing and proofing materials.
• Ability to independently present complex global regulatory strategies internally and to Atnahs partners.
• Ability to communicate comfortably and effectively with regulatory authorities.
• Ability to work independently, resolve problems, take initiative and schedule and complete tasks to deadlines.
• Ability to work successfully across cross-functional teams and environments.
• Enjoyment of working in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands.
• Ability to build strong professional relationships.
• Excellent professional English communication skills, both written and verbal.

Preferred Skills

• At least five years of relevant experience within a pharmaceutical company, CRO, CMO or similar organisation, with generalist regulatory knowledge.

Pay range and compensation package

We offer a competitive salary plus a bonus and rewards package, including holidays, employee recognition awards, social events, a pension scheme, and hybrid working.

Equal Opportunity Statement

We are committed to diversity and inclusivity.