Business Operations at Stalwart People Co.
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Head/GM - Drug Regulatory Affairs - Injectables Pharma (12-16 yrs)
Designation: G.M. (Head Drug Regulatory Affairs)
Location: Panchkula, Haryana
Qualification: B. Pharma, M. Pharma
Experience: 12-20 Years in injectable Pharmaceutical Company. Person will be responsible for overall activities related to the Drug Regulatory Affairs.
Minimum of 10 years of experience working in the pharmaceutical /
biotechnology industry with direct extensive experience in Regulatory Affairs;
Regulatory Affairs Certification (RAC) preferred.
Min 3 - 5 years experience in EU and USA procedures and regulations, Variation filing etc
Company: One of the Largest Pharmaceutical companies in Injectables and Oncology
Key Responsibilities :
- Responsible for managing activities of Regulatory Affairs with emphasis on global regulatory strategy and the preparation, review and submission of documents to SRA and other regulatory authorities.
- Provide regulatory advice to multidisciplinary teams on the regulatory requirements to support clinical and nonclinical development, including preparation of IND and CTA fillings.
- Lead multidisciplinary teams in the development and authoring of major regulatory documents such as pre IND advice, PIP.
- Lead, coordinate, write, critically review and provide strategic input on regulatory filing documents (e.g., eCTD Module 2 summaries, integrated summary documents, Investigator's Brochure, clinical study reports).
- Lead and facilitate MA grant, including team preparation, for meetings with various FDAs, EMA, and other regulatory authorities.
- Guide team to address queries smartly for shortest time to registration.
- Proactively identify program issues and implement appropriate regulatory strategies to mitigate risks.
- Oversee and ensure compliance with regulatory procedures and work practices.
- Develop and implement regulatory operating guidelines/SOPs and common work practices/strategies within the team.
- Train, mentor and supervise regulatory employees. Maintain a positive team spirit and lead by ethical principles Qualifications.
Must have :
- Experience with pharmaceutical, nonclinical, and clinical development of NDAs (in antibiotics preferred)
- Desirable to have been trained in large pharma or biotech and subsequently also found success in a small company to leverage his/her learnings.
- Demonstrated experience in the preparation and submission of CTAs, and (s)NDAs.
Desired Skills :
- Excellent written and verbal communication skills. Strategic thinker, planner with excellent organizational skills
- Proven ability to effectively work collaboratively in cross functional teams
- Master's degree in science within a relevant scientific discipline required; M.Pharm, Ph.D.
- Minimum of 10 years of experience working in the pharmaceutical / biotechnology industry with direct extensive experience in Regulatory Affairs; Regulatory Affairs Certification (RAC) preferred.
- Min 3 - 5 years experience in EU and USA procedures and regulations, Variation filing etc
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