Senior Manager Regulatory Affairs Biosimilars & Speciality Medicines

Job Title: Senior Manager Regulatory Affairs CMC - Biosimilars

Location: London

About ADVANZ PHARMA

ADVANZ PHARMA is a global pharmaceutical company with the purpose to improve patients' lives by providing the specialty, hospital, and rare disease medicines they depend on.

Our ambition is to be a partner of choice for the commercialisation of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with innovative biopharma and pharmaceutical development companies to bring medicines to patients.

Headquartered in London, UK, we have c700 employees based across more than 20 countries, including key countries in Europe, the US, Canada, and Australia. Our Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialisation partner network complement our global operations.

About the Role

The Regulatory Affairs CMC Biosimilar- Sr. Manager will provide strategic regulatory and scientific assessment on CMC aspects of biological products to bring new products to patients in the most efficient way. This will encompass effective Regulatory strategy planning, assessment of CMC sections and data presentation, risk analysis, support during Marketing Authorisation Application and Life Cycle Management of in-licensed and development projects.

This highly visible and influential role will involve exposure to Senior and Executive Management and requires an individual with a collaborative approach and the ability to link with and influence others.

Key responsibilities:

1. Strategic Regulatory assessment of several New pipeline and M&A products in support of ADVANZ PHARMA's strategic initiatives and objectives.
2. Support RA NPI Manager, Program Manager - TO and the Business Development and Licensing (BD&L) team, with the regulatory activities to ensure on time delivery of all pipeline projects.
3. Working together with multi-functional / geographical teams and other internal stakeholders to ensure that projects meet all key objectives and are delivered on time.
4. Proactively identify and highlight potential regulatory risks, hurdles or issues which may impact project scope, and ensure practical resolution or escalation where necessary.
5. Work with external partners throughout the project lifecycle to ensure all parties have all the necessary elements in place to successfully secure timely Marketing Authorizations.
6. Contribute to the preparation of briefing packages for Scientific Advice of Biosimilar products.
7. Participate during the interactions with Competent Authorities (EMA, National EU Authorities, Health Canada, TGA and others). Address issues/requests by the Agency during MAA.
8. Preparation of regulatory roadmaps and gap analysis for the development of biosimilars up to approval.
9. Writing or review of IMPD CMC sections if required.
10. Writing or review of Modules 2.3 and 3 of the CTD for MAA and LCM variations.
11. Provide support and guidance to the BD&L Team when evaluating new projects and M&A by conducting dossier due diligence.
12. Direct communication with regulatory authorities to facilitate productive dialogue when required.
13. Timely and accurate responses to all regulatory queries in relation to Regulatory Affairs-New Products group activities.
14. Alliance Management of the relationship with all new partners and their regulatory departments to ensure timely feedback to all queries.
15. Report on regulatory progress and issues for new products or LCM activities at all project team and Project Review Meetings, and to Senior Management as required.
16. Escalate risks / issues appropriately to remove barriers to success or advise of delays and other changes which may impact the regulatory approval timeline.
17. Propose improvements or alternative approaches to obtain improved project deliverables.

About You

We are looking for highly motivated individuals who are passionate about making a meaningful difference to patients' lives.

Qualifications:

• University degree in a scientific discipline
• Additional Regulatory professional qualifications

Experience & Competences

• Regulatory role in CMC writing and assessment in Bio Pharma Industry (at least 8 years +)
• Broad understanding and experience preparing Common Technical Dossiers
• Relevant and current experience in submissions/managing of National and European MAA and support product launches
• Experience working with Biologic and Biosimilar applications
• Experience working with Generic and NCE applications
• Experience interacting with EU regulatory authorities - Scientific advice meetings/ Pre-submission meetings
• Experience in Medical Devices
• International Regulatory experience

Knowledge & Skills:

• Broad knowledge and awareness of the European regulatory guidelines and legislation and idiosyncrasies in multiple markets.
• Use of electronic portals for dossier submissions
• Have a good understanding of early development programs which includes non-clinical studies (PD, PK and toxicology) and clinical development plans for multiple indications, especially of Biosimilar products.
• Broad knowledge of the CMC development aspects of a Biosimilar product.
• Good working knowledge of Regulatory IT systems
• Strong project management skills
• Excellent communication skills: verbal, written and presentation with the ability to present information in an engaging manner.
• Ability to work under pressure and to tight deadlines.
• Influencing / Assertiveness
• Extensive experience working in a fast paced, dynamic organization

Personal Qualities:

• Excellent interpersonal and influencing skills to a broad audience, including Senior Management.
• Trustworthy and collaborative, strong team player.
• Excellent organizational skills and experience managing multiple regulatory projects.
• Attention to detail and focus on Quality.
• Problem solving and solutions orientated
• Strives consistently to overachieve with high standards
• Approaches work with a sense of urgency
• Analytical mind-set, with good problem-solving skills

Why ADVANZ PHARMA?

The success of any company is driven by its people, and we are no different.

At ADVANZ PHARMA, we believe in empowering our people to be entrepreneurs and embrace challenges to enable personal and company growth in an agile and fast-paced environment. We strive to do that inclusively and responsibly, treating all employees with integrity whilst rewarding outcomes and impact.

Our teams are made up of people from all walks of life and backgrounds. We thrive in an environment where uniqueness is celebrated, but we are all united by the same passion to help improve patients' lives by providing and enhancing the specialty and hospital medicines they depend on.

As a business, we like to tap into new ideas and fresh perspectives. So, if you join us, you'll be empowered to own your work, explore new possibilities and make things happen.

But there's more to you - and us - than just work, which is why our culture, vision and values are so high on our agenda. We believe in gender equality and actively encourage women into senior roles - we have an active ADVANZ PHARMA Women's Network; almost 40% of our managers are women.

We work hard to recognise and reward talent, and we actively promote from within - last year, approximately 25% of our people across the company achieved promotions. In addition, we recognise talent with our annual Impact Awards, in which our top performers are rewarded for their hard work and dedication.

We offer flexible, agile working options, and you will also enjoy a highly competitive salary and benefits package.

To join us on our exciting journey, Apply now! *

*Please include a CV and Cover letter.