Product and Regulatory Development Manager

5 days ago

vadodara, India Ortolan Full time

Product & Regulatory Development Manager

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

Salary: Competitive + Benefits + Bonus

If you are agile, committed, and highly focused pharmaceutical professional, with experience in authoring and reviewing technical documents for regulatory submission, 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 directly into the Senior Director of Product Development, the key skills required to be successful in this role are an understanding of drug development and registration process in pharmaceuticals, excellent attention to detail, proactive nature and confident communication both within the business and with external partners. The ideal candidate would also be a problem solver with an inquisitive mind and appetite to develop their technical skills.

The 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:

Review of technical documents like: Specifications, Test Procedures, Process Validation Protocols/ Reports, Batch Manufacturing Records etc., ready for regulatory submission Authoring the relevant technical modules for dossier compilation ready for submission Mapping out and review of product development and/or regulatory strategy in line with project timelines Review of ASMF/DMF from API supplier as per product development/regulatory strategy Review and authoring scientific rationale/justification to RFIs received from regulatory agencies and/or other departments Active involvement in building/authoring/review of pre-submission/SA/pre-IND/NDA meeting package for submission planning Review of Clinical/BA/BE Protocol and coordinate with relevant Subject Matter Experts Active involvement in building global product development/clinical development and regulatory strategies. Due-diligence of in-licencing and acquired products Communication and coordination with the internal and/or external stakeholders for preparation/review of technical documents Provide project updates regularly to Project Management team and Execs

About you:

Candidates with relevant technical authoring/regulatory experience within a large-scale or multinational pharmaceutical company are likely to have the skills required to be successful in this role. We are also looking for:

Master's degree in Pharmacy (M.Pharm) Substantial relevant experience in technical authoring/regulatory, including Module 2 to 5 (CTD) authoring knowledge on recent and updated regulatory and technical guidance Proficiency in reviewing and authoring technical documents, including clinical package. Excellent analytical and problem-solving abilities Strong presentation skills Ability to work effectively in a fast-paced environment and meet tight deadlines Ability to build strong working relationships with internal and external stakeholders Exceptional verbal and written communication skills Self-motivated and a team player High level of integrity and professionalism

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.

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