Regulatory Affairs Contractor - Cosmetics and OTC's
- Recruiter
- i-Pharm Consulting
- Location
- Reading
- Salary
- Competitive
- Posted
- 01 Jul 2022
- Closes
- 08 Jul 2022
- Sectors
- IT, Contractor
- Contract Type
- Permanent
- Hours
- Full Time
UK REGULATORY AFFAIRS - CONTRACTOR
6 month contract
International CRO partnered with renowned pharmaceutical company
GBP65 per hour
Hybrid working - 2 days in High Wycombe, 3 days from home
KEY RESPONSIBILITIES
Management of a product or specified products within a therapy area for Cosmetics, OTC and/or Medical Devices
Supports the Northern Cluster team (as appropriate) for UK, Ireland and Malta products across the portfolio range .
Development of regulatory strategies, preparation of regulatory applications and support maintenance activities within relevant therapy area
Supports the team with regulatory activities for National and/or European procedures (Decentralised, Mutual Recognition) as appropriate.
Supports the team with regulatory strategies (local and regional) in line with business plan.
Supports the team to complete identified regulatory activities to ensure all regulatory obligations and business objectives are met.
Prepares and compiles regulatory submissions (Marketing Authorisations, Reclassifications etc.), responses to Regulatory Agency (RA) questions and other correspondence in accordance with EU regulations and guidelines.
Sign off of packaging material, leaflets, SmPCs and advertising material (as appropriate) to ensure regulatory compliance for submissions via Zinc, COCOON, Starfish systems etc.
Ensure Marketing Authorisations are maintained and renewed.
Inform the Regulatory Agency/Department of Health (as appropriate) of product discontinuations and licence cancellations.
Ensures compliance within the department by ensuring
Global, EAME and local databases are fully maintained.
Processes, SOPs, working instructions and Job Aids are adhered to.
Update relevant local and global databases (e.g Documentum, Aris, Connect etc.) to track current product information.
Provides regulatory advice and performs due diligence for product acquisitions and distributor agreements with third parties (as appropriate).
Note, if an individual is to have full interaction with the Health Authorities and respond to submissions on behalf of us, then the HCBI due diligence process must be completed prior to an individual having this contact.
Seek advice when appropriate.
Respond to requests for further information and queries.
Resolve any regulatory matters and expedite approval of pending applications.
Provides regulatory guidance to internal stakeholders, to allow them make key decisions on business critical activities and project feasibility.
If required, represent and provide regulatory advice at e.g. joint Company/Trade Association initiatives, Regulatory Agency meetings etc (as appropriate).
SKILLS, KNOWLEDGE; QUALIFICATIONS & EXPERIENCE
- 10 years of regulatory experience in development of regulatory strategies, regulatory applications and supporting maintenance activities with cosmetics, OTC and/or devices background.
Life sciences or chemistry graduate to honours level or equivalent.
Works with minimal supervision to plan, conduct, and manage regulatory submissions and multiple projects to meet department and company objectives.
Work with minimal supervision to determine and develop approaches to solutions with technical guidance on a variety of problems of moderate scope and complexity.
May mentor Graduate and Regulatory Executive and provide day to day support (as appropriate).
Project management, understanding of regulatory environment, interaction with the Regulatory Authorities (as appropriate), commercial / strategic awareness, implement regulatory strategy, managing and maintaining Marketing Authorisations etc
6 month contract
International CRO partnered with renowned pharmaceutical company
GBP65 per hour
Hybrid working - 2 days in High Wycombe, 3 days from home
KEY RESPONSIBILITIES
Management of a product or specified products within a therapy area for Cosmetics, OTC and/or Medical Devices
Supports the Northern Cluster team (as appropriate) for UK, Ireland and Malta products across the portfolio range .
Development of regulatory strategies, preparation of regulatory applications and support maintenance activities within relevant therapy area
Supports the team with regulatory activities for National and/or European procedures (Decentralised, Mutual Recognition) as appropriate.
Supports the team with regulatory strategies (local and regional) in line with business plan.
Supports the team to complete identified regulatory activities to ensure all regulatory obligations and business objectives are met.
Prepares and compiles regulatory submissions (Marketing Authorisations, Reclassifications etc.), responses to Regulatory Agency (RA) questions and other correspondence in accordance with EU regulations and guidelines.
Sign off of packaging material, leaflets, SmPCs and advertising material (as appropriate) to ensure regulatory compliance for submissions via Zinc, COCOON, Starfish systems etc.
Ensure Marketing Authorisations are maintained and renewed.
Inform the Regulatory Agency/Department of Health (as appropriate) of product discontinuations and licence cancellations.
Ensures compliance within the department by ensuring
Global, EAME and local databases are fully maintained.
Processes, SOPs, working instructions and Job Aids are adhered to.
Update relevant local and global databases (e.g Documentum, Aris, Connect etc.) to track current product information.
Provides regulatory advice and performs due diligence for product acquisitions and distributor agreements with third parties (as appropriate).
Note, if an individual is to have full interaction with the Health Authorities and respond to submissions on behalf of us, then the HCBI due diligence process must be completed prior to an individual having this contact.
Seek advice when appropriate.
Respond to requests for further information and queries.
Resolve any regulatory matters and expedite approval of pending applications.
Provides regulatory guidance to internal stakeholders, to allow them make key decisions on business critical activities and project feasibility.
If required, represent and provide regulatory advice at e.g. joint Company/Trade Association initiatives, Regulatory Agency meetings etc (as appropriate).
SKILLS, KNOWLEDGE; QUALIFICATIONS & EXPERIENCE
- 10 years of regulatory experience in development of regulatory strategies, regulatory applications and supporting maintenance activities with cosmetics, OTC and/or devices background.
Life sciences or chemistry graduate to honours level or equivalent.
Works with minimal supervision to plan, conduct, and manage regulatory submissions and multiple projects to meet department and company objectives.
Work with minimal supervision to determine and develop approaches to solutions with technical guidance on a variety of problems of moderate scope and complexity.
May mentor Graduate and Regulatory Executive and provide day to day support (as appropriate).
Project management, understanding of regulatory environment, interaction with the Regulatory Authorities (as appropriate), commercial / strategic awareness, implement regulatory strategy, managing and maintaining Marketing Authorisations etc