Sr Regulatory Affairs Director
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Kongens Lyngby
PharmaRelations is the Nordic market leader within talent services for the life science industry. We specialise in partnering with some of the top and most innovative organisations exclusively in the Life Science sector across our region. We add value to our clients and candidates with our consultancy services, outsourcing solutions and recruitment of specialists and leaders.
We are proud to again partnering with a Vicore Pharma - a top, innovative, research and development company dedicated to creating life-changing treatments for rare lung diseases. The company is currently rapidly progressing four development programs addressing fibrotic lung diseases and related indications. The lead candidate drug C21, a first-in-class, orally administered, angiotensin II type 2 receptor (AT2R) agonist, is in Phase 2 and 3 clinical development in Idiopathic Pulmonary Fibrosis and COVID-19, respectively, and has the potential to target multiple other disorders, given the dual vascular and anti-fibrotic effects.
Vicore is expanding the development pipeline and aims to strengthen the organization with a Sr. Regulatory Affairs Director to join the Clinical Development team in Stockholm or Copenhagen. The Clinical Development team currently consists of 7 highly dedicated and experienced people. The working environment is very flexible and pleasant, and with an informal atmosphere.
You will get the opportunity to be a key contributor to the success of Vicore. This requires interest in and knowledge in the area, as well as leadership in general. The position will cover CMC, preclinical and clinical development activities and is a full-time position.
Key responsibilities include:
Requirements:
Personal attributes:
Why?
The company is in growth with good economic conditions and has several products in the pipeline, in four different development programs, which shows the company's broad repertoire and diversity of activities. Furthermore, a completely new mechanism of action is explored, which in itself makes the company unique and leads to great opportunities.
More about the development programs VP01, VP02, VP03 and VP04:VP01 aims to develop the substance C21 for the treatment of idiopathic pulmonary fibrosis (IPF) and COVID-19. VP02 is based on a new formulation and delivery route of thalidomide and focuses on the severe, persistent cough associated with IPF. VP03 includes the development of new AT2R agonists. VP04 develops a clinically validated, CBT-based, digital therapeutic for IPF patients. The company's shares (VICO) are listed on Nasdaq Stockholm’s main market. For more information, see www.vicorepharma.com.
How?
For further information, do reach out to Kristina Edholm (Sr Recruitment Manager)or apply directly here. Due to GDPR, we cannot receive any CVs via e-mail. Interviews are already taking place, so please get in touch or apply at your earliest convenience.
At PharmaRelations we are committed to being an employer of equal opportunities for all and recruitment practices shall be free from discrimination based on race, color, ancestry, national origin, ethnic group identification, age. Religion, material or parental status, physical or mental disability, sex, sexual orientation, gender, gender identification or expression, or genetic information; the perception of one or more of such characteristics; or associated with a person or group with one or more of these actual or perceived characteristics.
We are proud to again partnering with a Vicore Pharma - a top, innovative, research and development company dedicated to creating life-changing treatments for rare lung diseases. The company is currently rapidly progressing four development programs addressing fibrotic lung diseases and related indications. The lead candidate drug C21, a first-in-class, orally administered, angiotensin II type 2 receptor (AT2R) agonist, is in Phase 2 and 3 clinical development in Idiopathic Pulmonary Fibrosis and COVID-19, respectively, and has the potential to target multiple other disorders, given the dual vascular and anti-fibrotic effects.
Vicore is expanding the development pipeline and aims to strengthen the organization with a Sr. Regulatory Affairs Director to join the Clinical Development team in Stockholm or Copenhagen. The Clinical Development team currently consists of 7 highly dedicated and experienced people. The working environment is very flexible and pleasant, and with an informal atmosphere.
You will get the opportunity to be a key contributor to the success of Vicore. This requires interest in and knowledge in the area, as well as leadership in general. The position will cover CMC, preclinical and clinical development activities and is a full-time position.
Key responsibilities include:
- Lead development and ensure implementation of a global regulatory strategy for candidate drugs to fit the company´s business needs and meet the appliable regulations.
- Oversee internal and outsourced regulatory activities related to Vicore’s development programs.
- Prepare, contribute to and/or review regulatory applications and documents e.g., IMPD/IND/CTAs, IBs, PIPs, annual reports, briefing documents for scientific advice and MAA/NDA, and coordinate regulatory activities related to above activities. Specify vendor management and oversight, if activities are outsourced.
- Plan, organize and participate in meetings with Health Authorities.
- Regulatory representative in development program teams and provide support to the clinical study teams, as needed.
- Regulatory review of clinical study outlines, CTPs and CTRs.
- Monitor new regulatory requirements and communicate requirements of legislation and guidance to the company.
Requirements:
- PhD or MSc in Life/Health Sciences.
- Solid regulatory affairs experience ( 10 years) from pharmaceutical industry or competent authority, preferably both with CMC and clinical development.
- Experience and knowledge of regulatory requirements in main markets and ability to interpret relevance for product development activities.
- Experience with Health Authority interactions.
- Excellent verbal and written communication skills in English.
- Ability to think critically, strategically and evaluate risk to regulatory activities.
Personal attributes:
- A high level of proactivity, commitment, and energy.
- Strong leadership and coaching skills.
- Strong communication skills.
- Excellent problem-solving skills and a “can do attitude”.
- Strong individual initiative, organization skills and multi-tasking abilities.
- Open and social personality and easy to work with.
Why?
The company is in growth with good economic conditions and has several products in the pipeline, in four different development programs, which shows the company's broad repertoire and diversity of activities. Furthermore, a completely new mechanism of action is explored, which in itself makes the company unique and leads to great opportunities.
More about the development programs VP01, VP02, VP03 and VP04:VP01 aims to develop the substance C21 for the treatment of idiopathic pulmonary fibrosis (IPF) and COVID-19. VP02 is based on a new formulation and delivery route of thalidomide and focuses on the severe, persistent cough associated with IPF. VP03 includes the development of new AT2R agonists. VP04 develops a clinically validated, CBT-based, digital therapeutic for IPF patients. The company's shares (VICO) are listed on Nasdaq Stockholm’s main market. For more information, see www.vicorepharma.com.
How?
For further information, do reach out to Kristina Edholm (Sr Recruitment Manager)or apply directly here. Due to GDPR, we cannot receive any CVs via e-mail. Interviews are already taking place, so please get in touch or apply at your earliest convenience.
At PharmaRelations we are committed to being an employer of equal opportunities for all and recruitment practices shall be free from discrimination based on race, color, ancestry, national origin, ethnic group identification, age. Religion, material or parental status, physical or mental disability, sex, sexual orientation, gender, gender identification or expression, or genetic information; the perception of one or more of such characteristics; or associated with a person or group with one or more of these actual or perceived characteristics.
Information og data
Denne ledige stilling har jobtypen "Jurist", og befinder sig i kategorien "Økonomi og jura".
Arbejdsstedet er beliggende i Kongens Lyngby.
Jobbet er oprettet på vores service den 8.9.2021, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Jurist
- Kongens Lyngby
- Fredag den 08. oktober 2021
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