Freelance Regulatory Consultant, Emerging Markets - Remote

3 days left

Location
United Kingdom
Salary
competitive pay rate
Posted
06 Feb 2021
Closes
08 Mar 2021
Ref
SAMRAEM62
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

SUMMARY

This position will report to the Head of International Regulatory Affairs and will be responsible for supporting the development and execution of submission strategies for assigned markets within the Emerging Markets, ensuring alignment with key stakeholders i.e. commercial, corporate, medical, R&D.

KEY RESPONSIBILITIES

  • Leads the planning and construction of the International dossier for assigned products.
  • Submission of marketing authorisation applications, variations, renewals, line extensions and responses to requests for further information.
  • Ensures appropriate cross-functional consultation with appropriate R&D and Commercial stakeholders.
  • Ensures effective regulatory representation in partnership with appropriate technical experts at all health authority meetings and clear documentation of the discussion and agreements where needed.
  • Coach and mentor junior regulatory staff members as needed by the line management.
  • Keep line management up to date on the status of regulatory strategies, submission and approvals and any risk and mitigation strategies.
  • Interfaces cross-functionally within RA, as well as with Commercial, Clinical Development, Global Marketing, etc. to identify what emerging markets requirements will impact the global strategy and how to best move forward to meet project plans.
  • Maintains a detailed knowledge of designated market regulatory requirements and guidelines and communicates changes in regulatory information to product teams and line management in a timely manner.

 

QUALIFICATIONS

  • Preferably a Life Science degree (BSc, MSc, PhD.)
  • Relevant experience in regulatory Affairs.
  • Direct experience of working in the International region (ex-US/EU) Regulatory Affairs including International markets (Japan, China, S.Korea, Taiwan, Australia/NZ, Mexico, Brazil, etc.) is mandatory.
  • Proven experience of filing new marketing authorisation applications and post-marketing activities in the International regions (ex- US/EU).
  • Experience of interactions with Regulatory Authorities or local business partners within the APAC or LATAM region.

 DURATION

1.0FTE / 1 year contract

SALARY

Competitive hourly pay rate (very attractive approach to IR35)

LOCATION

UK – Fully remote (or office based in the South if preferred)

ABOUT PLANET PHARMA

Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.

Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

www.planet-pharma.com

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