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Senior Manager Life Sciences Practice; Regulatory Services

Date: Oct 13, 2021

Location: London, United Kingdom

Company: KPMG UK

The Role

Lead client engagements and define pharmaceutical or medical device regulatory service needs, project timelines, strategic goals and client expectations for delivery of regulatory services.

Lead regulatory affairs services with an emphasis on regulatory strategy and the preparation, review and submission of documents to regulatory authorities globally.

Provide life science regulatory advice to cross-functional teams on regulatory requirements to support regulatory submissions to authorities in different global jurisdictions.

Lead teams responsible for the technical review, authoring or assembly of Clinical, Pre-Clinical or CMC dossiers, for example preparation and maintenance of IND, CTA, EU IMPD, NDA, BLA, MAAs or scientific advice procedures with global regulatory authorities.

Lead research strategy for clinical development and product development plans for pharmaceutical products or medical devices and product launch considerations with Managers.

Able to effectively communicate with clients and project teams through correspondence, regulatory status reports as defined and agreed with the client.

Advanced understanding of the global regulatory environment and advises clients of regulatory changes in the future within Life Sciences and how these changes should be managed.

Maintains current knowledge of EU, FDA and global regulations as necessary depending on client requests.

Advise clients on the impact of the changing pharmaceutical regulatory landscape on their business models and support them through change.

Provide subject-matter expertise on engagements run by others.

Develop and maintain strong relationships with clients and build an external network

Develop and maintain strong relationships with KPMG colleagues and build an internal network

Lead mentoring, coaching and development of colleagues.

Lead with business development opportunities for the Life Science Regulatory Services Team and wider business, which might include building propositions and taking these to market as well as identifying opportunities for on-sell from existing client engagements.

Lead research, insight development and knowledge management.

Ensure the delivery of all client work and internal projects to a high standard

Qualifications and Skills:

- Life Sciences Degree BSc; Law Degree LLB; or related Degree BA and or higher qualification

A minimum of 8 years life science regulatory services experience

Expertise delivering pharmaceutical regulatory services e.g. program management, Clinical, Pre-clinical or CMC.

Expertise in medicinal product and or medical device regulatory services.

Expertise with pharmaceutical product development.

Excellent written and verbal communication skills.

- Active listener.

- Planning and project management skills.

- Proven ability to achieve results, even when faced with obstacles or setbacks.

- Positive and flexible attitude to work and a willingness to embrace new initiatives.

- Networking, influencing and stakeholder management.

- Confident and highly motivated individual.

- Flexibility to work across the UK (and internationally) where required.

Experience and Knowledge:

- Knowledge of the Pharmaceutical and or Medical Device regulatory service industry is important

Advanced understanding of pharmaceutical regulations and an ability to identify and interpret legislation, guidelines, and all relevant information published by global regulatory bodies is important

Ability to work with interdisciplinary team members, manage timelines and compile documents for global regulatory submissions is important

Ability to identify global risks to client assets and to assist Managers to provide solutions to regulatory authority challenges and requests globally.

- Previous experience in consulting roles or working for a regulatory authority is desirable but not essential.

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