Head - Regulatory Affairs - Pharmaceutical

Industry - Pharma / Biotech / Clinical Research

Category - Operations

Job Type - Permanent

Job Description :

- This position will be responsible for managing all activities within RA in India, SL and Pakistan. The incumbent is expected to align RA activities to local/regional business strategies

Client Details :

Our client is a global leader in the pharmaceutical industry. They have been in the business for more than 100 years.

Description :

- Staying current with the relevant regulations, legislations and policies in responsible countries, and provide timely update and assessment to Regional RA/LTD to assist in development or revisions to global product development/maintenance strategies.

- Developing and maintaining SOPs and related documents for regulatory affairs under the direction of Regional RA/LTD

- Develop and implement regulatory strategies for new/generic product registrations, medical devices, variations, licence renewals, and importation permission in compliance with relevant regulations and the company's plan

- Manage submission of application dossiers with relevant regulatory authorities, monitor the review process and take appropriate actions to obtain regulatory approvals as planned.

- Support Artwork and labelling process development. Review and approval of artwork as per current SOP, regulations and laws of D&C Act.

- Representing the organization, to build and maintain strong relationships with relevant government agencies, industry groups or associations in India.

- Work in collaboration with local, regional and global business partners to provide regulatory insights, and to facilitate execution of business strategies and plans.

- Train and develop regulatory affairs team member on strategic thinking, and to improve technical and practical knowledge skillset.

- Back-up for local PV Officer In-charge (PVOI) to handle safety reporting during PVOI's absence.

- Supporting commercial functions (e.g. marketing, market access) to review, submit, follow up and archive promotional materials and events (e.g. symposium etc).

- Management of RA activities in collaboration with distributors in Sri Lanka and Pakistan

- Management of RA Department. Involve in day to day activity of the Department, management of the team and assigning the task to them on daily basis and ensuring the completion of the task in time. Approval of the departmental bills, attendance & leaves of team member. Providing guidance & support to the team in accomplishment of their task.

- Prepare and submit monthly RA update and participate in monthly meeting for relevant departments, and periodic budget/forecast updates for RA function.

Profile :

Essential Qualifications:

- Graduate/Post Graduate in Pharmacy or any relevant graduation and post-graduation with regulatory affairs experience.

Experience:

- Good knowledge of Regulatory Affairs for India and SAARC market with more than 8 years' experience.

- Additional experience in handling Pharmacovigilance and/or Quality Assurance for any Indian or multinational pharmaceutical company ideal but not essential.

Skills:

- Knowledge of Indian and SAARC market regulations related to pharmaceuticals, Medical Devices, OTC, Biologicals and Nutraceuticals.

- Knowledge of products development process, eye diseases, ophthalmic products

- Strong industry network and knowledge

- Fluency in English both in speaking and writing

- Having good MS Office software skills

- Careful and self-disciplined

- Have strong negotiation and communication skills

Job Offer

An opportunity to work in a leadership role with one of the world's oldest and most reputed pharmaceutical firm.

To apply online please click the 'Apply' button below. For a confidential discussion about this role please contact Utkarsh Gupta on +91 124 452 5469.

Contact - Utkarsh Gupta - +91 124 452 5469

The Apply Button will redirect you to website. Please apply there as well.