Regulatory Affairs Manager

Regulatory Affairs Manager

Mumbai, India (hybrid: 3 days office, 2 days home)

Salary: Competitive + Benefits + Bonus

If you are an agile, committed, and innovative regulatory affairs professional in the pharmaceutical sphere, 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 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, U.A.E., India, Singapore, Italy, Spain, and South Korea.

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:

Reporting to the Associate Director, Regulatory Affairs, you will be a key member of the team responsible for providing strategic and operational regulatory support to project management on new divestment projects, technical transfer, CMOs, and quality assurance and commercial departments.

Our Regulatory Affairs Department has an ethos of continuous improvement, refining systems and creating efficiencies. This, along with the rapid growth of the business, leads to a varied and dynamic working environment.

Main responsibilities & duties:

• Providing strategic and operational regulatory support to project management on new divestment projects, technical transfer, CMOs, quality assurance and commercial departments
• Leading the preparation of core dossiers and submissions for global roll out
• Authoring, reviewing and approving M3 dossier sections as necessary, justification documents and Product Information
• In collaboration with global partners, consultancies and distributors, outlining global regulatory intelligence and form a global regulatory strategy
• In collaboration with senior management and project strategy teams, developing and reviewing global cross functional regulatory strategies
• Ensuring diligent reporting and progress updates on regulatory workload at weekly/bi-weekly internal regulatory meetings
• Negotiating and making agreements on behalf of the department
• Interpreting applicable regulations and guidelines for project team use, keeping project teams abreast of regulatory decisions, evolving regulatory requirements, risks and mitigation plans
• Serving as a primary contact to the local health authority (HA(s), local consultancies/ distributors and internal stakeholders, to ensure timely and accurate submissions
• Facilitating communication between the HA(s) and the project team. Attends and generally leads agency meetings, if required
• Coordinating and soliciting components of the submission from various functional areas, distributors and CMOs
• Proactively identifying project issues to the project team and supporting mitigation plans
• Attending cross functional meetings, vendor meetings and kick-off meetings as required
• Mentoring and/or managing other Regulatory Managers, Regulatory Associates and other junior level or administrative Regulatory staff
• Maintaining a high level of professional expertise through familiarity with scientific literature and participation in training courses
• Other responsibilities may include interviewing, hiring, and training employees; planning, assigning, and overseeing regulatory submissions

About you:

Candidates with at least 5 years of regulatory generalist experience within a pharmaceutical company, CRO, CMO, or similar organisation, are likely to have the skills required to be successful in this role. We are also looking for:

• Bachelor's degree in science/health discipline
• Great IT skills including MS Word, Excel, Project, PowerPoint, and Outlook
• Expertise in regulatory submission structure and content (e.g., MAA, NDA)
• Expertise in artwork requirements and review in line with regulations
• Strong knowledge of EU regulatory framework and guidelines
• Experience in compliance and maintaining product life cycle databases and RIMs systems
• Ability to effectively communicate with regulatory authorities
• Ability to independently present complex regulatory strategies with internal stakeholders and partners
• Awareness of emerging markets submission rollouts
• Expertise in writing scientific and technical documents, and strong attention to detail with proofreading materials
• Excellent time management skills with demonstrated ability to juggle multiple competing tasks and demands
• Strong organisational skills to establish priorities including scheduling and meeting deadlines
• Ability to work successfully within cross-functional teams
• Excellent professional communication skills, both written and verbal
• Fluent English language (written and verbal) is required, and another language, especially Italian or French, is desirable

What we offer:

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