Job Description

Regulatory Affairs Manager Benefits JOB TYPE: Permanent EMPLOYMENT TYPE: Full-Time EXPERTISE: PHARMACEUTICAL REGULATORY AFFAIRS SALARY TYPE: Annually SALARY: Negotiable REPORTS TO: Managing Director VACATION LEAVE: paid LOCATION: Shimla, Himachal Pradesh, India. This role will be office-based or hybrid REQUIRED: Direct experience working with UK MHRA / US FDA EuroNoxx Pharma We\'re EuroNoxx Pharma Ltd is a subsidiary of EuroNoxx Reserves (OPC) Private Limited, a new global pharmaceutical company, committed to increasing access to high-quality healthcare to patients around the world. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. We are looking for a Regulatory Affairs Manager to join our growing team. You will be responsible for European and global licensing for medicines and over-the-counter (OTC) products. You will be vital to the team, driving regulatory activities, which will ultimately contribute to the growth and success of the company. You will directly report to the Managing Director. Responsibilities

• You will oversee all regulatory activities for assigned projects including regulatory strategies, health authority advice, dossier risk assessments, compilation and submission of applications (post approval and new submissions), resolution of Health Authority questions in cooperation with other functions, post-approval commitments and submission of variations/renewal applications where requested.
• You will perform the necessary regulatory tasks \xe2\x80\x93 i.e. dossier compilation, data and documentation review, submission execution, file quality rating etc. - to obtain new Marketing Authorisations in UK and EU mainland for all products.
• You will review, compile and submit high quality regulatory submission packages to the UK MHRA US FDA and EU EMA.
• You will work closely, understand and communicate complex issues with manufacturing, QA, packaging testing, artwork origination and release sites, plus Medical and Pharmacovigilance departments, in order to support the preparation, compilation, review and submission of high quality regulatory documentation in accordance with UK/EU requirements, legislation, guidance and EuroNoxx Pharma procedures.
• You will provide timely UK/EU specific documentation and/or information in support of UK and EU new submissions and/or variations and renewals.
• You will co-ordinate resource effectively to ensure that Regulatory approvals are secured in line with business timelines, and regulatory project support is provided.
• You will work closely with line management to identify, evaluate and communicate clearly all perceived and evolving regulatory risks to project and business teams.
• Help to develop colleagues through mentoring and training.
• Keep up-to-date with changes in regulations and guidance.
• Participate in business development activities relating to clinical regulatory services, including bid defence presentations.

Qualifications

• Degree in life sciences/pharmacy or equivalent qualification(s)
• Experience in the Pharmaceutical Industry, including experience within EU or UK / US Regulatory Affairs (must have)
• Additional experience in R&D, Quality, chemistry, manufacturing and control (CMC) or Operations (desirable)

Skills

• Excellent oral and written communication
• Able to work effectively under pressure in a global matrix
• Creative thinking
• Team worker
• Analytical (data rational)

Get in touch to hear more about this new exciting opportunity! Email your CV to: Human Resources euronoxxreserves.com Job Type: Full-time Salary: 960,000.00 - 9150,000.00 per month Schedule:

• Monday to Friday

Supplemental pay types:

• Commission pay

Experience:

• total work (Preferred)