Head/GM - Drug Regulatory Affairs - Injectables Pharma

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

Qualification:

- 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