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Job Details

CMC Consultant

Company: Pharmalink Consulting
Reference: 1401
Closing Date: 19 Jun 17
Type: Contract
Salary (£): Competitive

Job Summary:

Genpact Pharmlink is a highly specialised Regulatory Affairs Consultancy with a successful history. The success of Genpact Pharmalink depends on its people. Capitalizing on what is unique about individuals and drawing on their different perspectives and experiences will add value to the way we do business.


Job Description

Regulatory Affairs Manager (Labelling)



A reputation for excellence in regulatory affairs labelling attracts people from all over the world to Genpact Pharmalink – with major offices in North and South America, India and the UK. We work with the top 20 global pharmaceutical and biotech companies, as well as a diverse portfolio of small, emerging companies and start-ups. We have partnered with some of the biggest names in the healthcare world to ensure their products are safe, and efficacious as well as compliant and profitable!

Join our team and you'll have the chance to make a profound difference to our clients and to your career. 


Overview of the job

·         Take responsibility for assigned Regulatory activities associated with Labelling and

Pharmacovigilance support across Europe, including Summary of Product Characteristics (SPCs), Patient Information Leaflet (PIL) text and Company Core Data Sheets (CCDs).

·         Maintain records of tasks and registered product information in the internal regulatory


·         Provide guidance and support to other team members.



·         Advise on the strategy to address any labelling specific questions from Regulatory

Agencies, Associate Companies, other Regulatory Affairs personnel or other sources as


·         Write and update Patient Information Leaflet text for products authorised through the

Mutual Recognition, Decentralised or Centralised Procedure.

·         Schedule the user testing programme for PILs.

·         Act as primary contact for user testing service providers. Place user testing projects with

contract organisations, ensure compliance with agreed timelines, monitor budget and track


·         Provide regulatory advice for the preparation of Summary of Product Characteristics

(SPCs) for new products in association with the relevant project team members and

functional experts.

·         Liaise with Worldwide Drug Safety and Pharmacovigilance and relevant project teams

regarding the preparation, revision, review and issue of CCDs.

·         Maintain CCDs in the Regulatory Affairs document management system.

·         Monitor compliance of SPCs with CCDs across the associated companies and 3rd parties in Europe.


Pharmacovigilance Support:

·         Record Global Periodic Updates Requirements (GPSUR) requirements and safety

submission activities in the GPSUR database.

·         Collect and collate Regulatory data for provision to International Drug Safety Centres

(IDSCs) for inclusion in GPSURs.

·         Ensure timely despatch of GPSURs to the relevant associated companies and European

Regulatory Authorities and record submission dates.



·         Advise junior staff on data requirements for their activities.

·         Be aware of relevant scientific and technical information.

·         Lead interdisciplinary project teams, which are moderately complex.

·         Take a high degree of personal responsibility for representing the Department both

internally and externally.

·         Take a high degree of personal responsibility for decision making and problem solving.

·         Provide expert advice on items or issues which affect the Company.

·         Displays the leadership attributes in particular ownership and responsibility, and flexibility

and works by Company values.

·         Participate in project teams and provide guidance in areas of expertise for both research

and marketed products.

·         Provide guidance and support to other team members.





·         Science degree or equivalent qualified: e.g. chemical and physical sciences, pharmacy,

biochemistry, medical chemistry, biomedical science; or HND or equivalent industry

experience where appropriate.

·         High level of technical regulatory experience.

·         Excellent understanding of relevant Regulatory Guidelines and legislation.

·         Excellent analytical and problem-solving skills.

·         Ability to influence internal and external bodies.

·         Possesses excellent written and oral communication skills.

·         Positive work style, with an approachable, flexible manner.

·         Has a high attention to accuracy and detail.

·         Is IT literate particularly in relation to using databases and document management




·         Taking personal responsibility and accountability for managing and delivering Regulatory


·         Project managing and leading tasks.

·         Taking a high degree of personal responsibility for decision making and problem solving.

·         Working to strict deadlines and managing own time.

·         Building effective working relations internally and externally.

·         Working unsupervised.

·         Actively working as a team member.

Apply for this job: CMC  Consultant

Contact Information:

Address:  Pharmalink Consulting
Vandervell House
Vanwall Business Park
Tel:  +44 (0) 1628 860300
Fax:  +44 (0) 1628 860400
Website:  Visit Our Web Site

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