Match score not available

Senior Specialist - Regulatory CMC - REMOTE

Remote:

Full Remote

Contract:

Full time

Experience:

Expert & Leadership (>10 years)

Work from:

India

Offer summary

Qualifications:

Degree in Life Science, higher degree preferred, 7-10 years of Pharma work experience, Minimum 5 years in regulatory affairs for medical devices and drug/device combinations, Experience with global submissions and life-cycle management.

Key responsabilities:

Contribute to dossier content and regulatory strategy development
Prepare and manage regulatory documentation
Lead continuous improvement and strategic thinking efforts
Participate in office duties matching global team hours

Lifelancer Information Technology & Services Startup https://lifelancer.com/

11 - 50 Employees

See more Lifelancer offers

Job description

Your missions

Your Role:

Ability to contribute to the dossier content and to support the life cycle management of regulatory Devices and Drug/Device combination activities.
Ability to develop, prepare and implement successful regulatory strategies and dossiers.
Experience in preparation and management of regulatory documentation, including full global submission roll outs (new product application) or large variations for medical devices and/or drug device combination products.
Experience with life-cycle management activities within the medical devices and drug/device combination products including prefilled pens, electronic autoinjectors and pre-filled syringes in the EU/US and International markets.
Understanding and awareness of global pharmaceutical and medical device legislation
Awareness of regulatory affairs contribution to Pharma business
Basic understanding of concepts of project management and Regulatory affairs
Good written and spoken English communications.
Ability to think strategically, to perform root cause analysis and to propose and drive continuous improvement.
Normal and routine office duties (hours of work may be adapted to match the Global team in EU and US region)
Position may require both domestic and international travel.

Who you are:

Education

Degree in a Life Science related disciplines, Pharmacy, preferably higher degree (e.g., MSc in scientific discipline or M. Pharm or Masters in Regulatory affairs)

Work experience:

7-10 years of overall work experience in Pharma environment
Competent authority or Academia/R&D experience related to the role.
Minimum 5 years of experience in regulatory affairs in medical devices and drug/device combinations.

Please apply on the Lifelancer platform at the below link for screening steps & quicker response.

https://lifelancer.com/jobs/view/42beadceddec265db65bc77ace4b669b