CMC Regulatory Affairs Director
Affibody AB is looking to recruit a CMC Regulatory Affairs Director to strengthen the company’s capabilities within Chemistry Manufacturing and Controls (CMC) and Regulatory Affairs. The role will be part of the Regulatory Affairs team and will be located at our premises in Solna.
The Regulatory team manages strategies and oversight of all regulatory submission and authority advice for Affibody and its development partners. The function holds the responsibility for strategic and operational regulatory input to our development plans, as well as regulatory operational tasks to support submission activities.
The role in general
The person suitable for this role has a strong interest in CMC regulatory affairs and medical device development. You will collaborate with the CMC team and together develop strong and sustainable CMC plans to support our projects. You need to be up to date with the industry regulatory standards and the development of biopharmaceuticals.
As CMC Regulatory Affairs Director your main responsibilities will include:
- Preparation and delivery of strategic CMC contributions to regulatory submissions
- Together with the CMC team author the CMC part of regulatory documentation, including e.g. IND, CTA, briefing documents etc.
- Be up to date with and give support in quality and regulatory requirements for biopharmaceutical drug development
- Lead the regulatory part of medical device and combination product development
- Oversee internal and outsourced regulatory CMC activities
- Participate in authority interaction and prepare company positions in alliance with internal specialists
- Participate and provide advice for the preparation of the quality TPP
- Responsible for internal regulatory intelligence within regulatory CMC
- Write and/or review internal and external SOP´s within regulatory CMC
The right candidate mainly fulfills the following qualifications:
- PhD or MSc in Life Science or equivalent
- Regulatory Affairs experience (>10 years) with focus on CMC from the pharmaceutical industry or competent authority
- Experience of authoring CMC documentation, IMPD, CTD module 3
- Experience of development and requirements for medical devices and combination products
- Ability to think strategically and evaluate risk to regulatory CMC activities
- Understanding of cGMP manufacturing of biologics and industry regulatory standards
- Experience of cross-functional team work
- Excellent verbal and written communication skills in English and ability to communicate in a business environment.
To be successful in the role you need to be highly self-motivated and driven. You need to be comfortable working in a dynamic environment in a growing organization and in cross-functional teams. You have strong team working skills and can establish and maintain good collaboration with different parties both externally and internally.
You have capabilities to analyze complex information or situations and provide sound solutions to regulatory strategies. The role requires both operational management and strategic overview. You have the ability to prioritize activities in order to deliver business critical goals in time.
In this recruitment we are collaborating with Haeger & Carlsson. Welcome to apply through this link.
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Affibody in short
Affibody is a Swedish biotech company focused on developing next generation biopharmaceuticals based on its unique proprietary technology platforms: Affibody® molecules and Albumod™.
Upcoming reports Financial calendar
- Interim Report January to March 2020 (May 15, 2020)
- Interim Report January to June 2020 (August 21, 2020)
- Interim Report January to September 2020 (November 13, 2020)
- Year End Report 2020 (February 2021)