Liaisoning - Regulatory Affairs - Pharma

Job Description:

Job Title: Local Regulatory Liaison (EU Region)

Employment Type: Full time

Location: Bangalore, India

About Company :

Company is an innovation driven company providing platforms, services and solutions to global life sciences clients addressing their critical business and scientific needs. Our platforms, services and solutions include Pharmacovigilance, Regulatory Affairs and Clinical Research. Company's corporate office is based out of Princeton, NJ and has offices in Philippines & India. Led by a strong management team, with decades of experience and thought leadership with leading pharmaceutical, biotech, medical devices, consumer healthcare and technology enterprises, Company is designed to deliver high quality and cost effective solutions and services for our clients in the Americas, Europe, Asia and Australia.

Overview:

The local regulatory liaison provides support to product portfolio through execution of regulatory maintenance activities on existing products (OTC and non-OTC) and expanding portfolio with new product registrations where required in local markets within EU region. This individual principal responsibilities include preparation, submission and obtaining approval for marketing authorization variations from health authorities for OTC product licenses (where required in local markets) with support from Regional Regulatory colleagues.

Additional responsibilities will include preparation, submission and obtaining approval for marketing authorization applications from health authorities for OTC product licenses (where required in local markets) with support from Regional Regulatory colleagues; preparation, submission and obtaining approval changes to product labeling from health authorities for OTC product licenses (where required in the local market) with support from Regional Regulatory colleagues; preparation, submission and obtaining approval for reclassification applications from health authorities (where required in local markets) to enable OTC marketing of products in that market; preparation, submission and obtaining approval for responses to any requests for further information from health authorities with regards to above-mentioned tasks, with support from Regional Regulatory colleagues.

The local regulatory liaison will prepare risk assessments for non-OTC products (where required for local markets).

- He/she may review and approve artwork for NPI for non-OTC products (where required in local markets) with support from Regional Regulatory colleagues in addition to reviewing and approval of artwork changes for existing non-OTC products (where required in local markets) with support from Regional Regulatory colleagues.

- He/ she may also review and approve promotional materials for non-OTC products (if required) and ensure all global, EU and local databases and trackers are maintained (e.g. Aris Register, CONNECT, Documentum, CCDS trackers, spontaneous report tracker. Furthermore, responsibilities will include responding to CFIs for local markets wherever required and seeking support from Regional client's Regulatory colleagues when required.

- In addition to monitoring changes in regulatory environment for both OTC and non-OTC areas and highlight any potential impact to client's products to Regional client's Regulatory colleagues.

Roles & Responsibilities:

Specific day to day responsibility of the local regulatory liaison role (within EU region) includes, but not limited to:

- Ensure that standards and timelines are met.

- Ensure that relevant local processes for specific tasks are followed.

- Create and update working practices for processes used between outsource partner & EU Regulatory Affairs for OTC and non-OTC products, using lessons learned approach.

Essential Skills Required and Education:

- Life Science Degree or equivalent qualification.

- Experience in European Regulatory Affairs for pharmaceutical products, including managing product registrations, variations and renewals within mutual recognition procedures.

- Experience with cosmetic, medical devices and commodities within EU.

- Experience with local markets in EU.

- Experience with OTC products would be desirable.

- Experience working across the full medicinal product regulatory dossier (modules 1-5).

- Demonstrate excellent communication skills - both oral and written.

- Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific and manufacturing.

- Well organized, detail-oriented excellent attention to detail.