Mexico (remote)

Regulatory Affairs Manager (Mexico)

Based in Mexico (remote)

Salary: Competitive + Bonus + Benefits

If you are an agile, committed, and innovative regulatory affairs professional in the pharmaceuticals 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 Global RA Lead, as Regulatory Affairs Manager (or Senior Manager, depending on experience) you will lead the establishment of Regulatory Affairs management in the LATAM region.

Responsible for all aspects of the LATAM Regulatory Strategy, you will support the growth of the pipeline in LATAM. In this role you will work closely with the Global Regulatory Lead, Regulatory Product Leads, Scientific Affairs and General Manager in cross-functional project teams, to ensure LATAM growth strategies are realised.

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:             

  • Lead Pharmanovia’s Regional operations strategically aligned to growth plans in LATAM
  • Establish regional infrastructure and ensure regulatory compliance with the national competent authority legislation for the marketing and distribution of Pharmanovia’s products
  • Lead the successful launch of new product development by ensuring the timely roll out of new applications and post approval changes regionally 
  • Establish regulatory strategies and develop submissions for CTAs, CTA exemptions, NDA submission, pre-NDA meetings, life-cycle management and labelling management
  • Regional regulatory lead representing due diligence assessments and development opportunities
  • Ensure planning and optimal organisation of regional regulatory activities
  • Drive growth opportunities in LATAM through strategic planning and in depth understanding of the regulatory framework in LATAM
  • Ensure full readiness and compliance of the local entity and all related activities for products commercialization
  • Serve as a critical member of the Regulatory Affairs team providing LATAM focused product development strategies and the registration of foreign developed products
  • Lead interactions and submissions with the COPEFRIS and related Health Authorities for LATAM markets
  • Monitor, identify and communicate regulatory environmental trends and regulation development which would influence Pharmanovia’s growth opportunities

About you:

Candidates with at least 5 years of regulatory affairs experience within a multinational pharmaceutical company are likely to have the skills required to be successful in this role. We are also looking for:

  • Master’s degree or above in pharmacy, medicine or chemical sciences
  • Great IT skills including MS Word, Excel, Project, PowerPoint, and Outlook
  • Proven record and recent experience of CTA/NDA and associated strategy in LATAM
  • Good understanding of the regulatory infrastructure required for the marketing and distribution of pharmaceutical products
  • Strong knowledge of local regulatory framework and guidelines
  • Must be able to independently present complex global regulatory strategies internally and to Pharmanovia’s partners
  • Expertise in writing scientific and technical documents, and strong attention to detail with proofreading materials
  • Overall global expertise, professional gravitas and strong influence skills and will display personal and professional maturity
  • Data driven in decision making with the ability to analyse complex situations, focus on the key issues and communicate within the team and upwards with clarity and concisely
  • Must be able to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands
  • Strong networking, planning and organisational skills with a demonstrated capability to manage complex projects with short timelines
  • Ability to work successfully within cross-functional teams
  • Excellent professional communication skills, both written and verbal
  • Fluency in both Spanish and English languages required

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.

                                         

Apply now and become part of our team

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